Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function
- PMID: 40197799
- PMCID: PMC11977049
- DOI: 10.1002/14651858.CD014855.pub2
Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function
Abstract
Background: Kidney transplantation is the preferred therapy for many patients with kidney failure. Delayed graft function (DGF) is more common in donors after cardiac death (DCD), especially those with older age, longer cold ischemia time, or higher creatinine levels. Currently, there is no agreement on the optimal immunosuppressive approach for patients at increased risk of DGF. Strategies include delaying the introduction of calcineurin inhibitors (CNI) or using an initial low dose of CNI.
Objectives: To evaluate the benefits and harms of delayed initiation of CNI or reduced CNI dose as initial immunosuppression therapy for kidney transplant recipients at high risk of DGF.
Search methods: The Cochrane Kidney and Transplant Register of Studies was searched up to 11 December 2024 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, and EMBASE, conference proceedings, the International Clinical Trials Registry Platform (ICTRP) Search Portal, and ClinicalTrials.gov.
Selection criteria: All randomised controlled trials (RCTs) and quasi-RCTs evaluating delayed versus early initiation of CNI or reduced versus standard initial dose of CNI in kidney transplant recipients at high risk of DGF.
Data collection and analysis: Three authors independently assessed study eligibility, and two assessed the risk of bias, certainty of evidence, extracted the data, and performed the analysis. Results were reported as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes and as mean difference (MD) with 95% CI for continuous outcomes. Statistical analysis was performed using the random-effects model. Risk of bias was assessed with the Cochrane risk of bias assessment tool 1.0, and the certainty of the evidence according to the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) methods, which are presented in the summary of findings tables.
Main results: We included 12 studies (2230 randomised participants). All studies were performed in Europe. Around 60% of the participants were males, reflecting the expected proportion in the population on kidney replacement therapy in Europe. Most studies had insufficient information to judge adequate random sequence generation and, or allocation concealment. All studies were unblinded, and judged as high risk of bias for DGF if the definition was based on need for dialysis, and for acute rejection if the diagnosis did not require a biopsy. Overall, the level of certainty was low, and reasons to downgrade were mainly due to risk of bias and imprecision. Delayed versus early initiation of CNI There may be little or no difference in DGF between the groups (6 studies, 905 recipients: RR 0.92, 95% CI 0.76 to 1.12; low certainty evidence) or in acute rejection (8 studies, 1295 recipients: RR 1.02, 95% CI 0.75 to 1.40; low certainty evidence). Delaying the initiation of CNI probably makes little or no difference to eGFR (6 studies, 851 recipients: MD -0.81 mL/min, 95% CI -3.33 to 1.72; moderate certainty evidence). Delaying the initiation of CNI may make little or no difference to graft loss censored for death (8 studies, 1295 recipients: RR 1.58, 95% CI 0.68 to 3.65; very low certainty evidence) or to all-cause death (8 studies, 907 recipients: RR 1.08, 95% CI 0.54 to 2.14; very low certainty evidence) although the evidence is very uncertain. There is probably little or no difference in all infections between the groups (6 studies, 1226 recipients: RR 1.10, 95% CI 0.97 to 1.25; moderate certainty evidence). Low versus standard initial dose of CNI There may be little or no difference to DGF between the groups (5 studies, 983 recipients: RR 1.16, 95% CI 0.90 to 1.50; low certainty evidence) or in acute rejection (5 studies, 947 recipients: RR 0.83, 95% CI 0.52 to 1.30; low certainty evidence). Starting CNI at a lower dose may make little or no difference to eGFR (5 studies, 935 recipients: MD 4.06 mL/min, 95% CI -1.36 to 9.48, low certainty evidence). Starting CNI at a lower dose may make little or no difference to graft loss censored for death, although the evidence is very uncertain (5 studies, 983 recipients: RR 1.05, 95% CI 0.64 to 1.71; very low certainty evidence), or to all-cause death (4 studies, 521 recipients: RR 1.01, 95% CI 0.41 to 2.47; low certainty evidence). There is probably little or no difference in all infections between the groups (4 studies, 828 recipients: RR 0.87, 95% CI 0.71 to 1.07; moderate certainty evidence).
Authors' conclusions: There may be little or no difference in DGF or acute rejection when delaying the start of CNI or when starting it at a lower dose in kidney transplant recipients at high risk of DGF. The available data are of low certainty.
Trial registration: ClinicalTrials.gov NCT00470665 NCT00681213 NCT01895049 NCT03644485 NCT03797196.
Copyright © 2025 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Conflict of interest statement
Laia Oliveras: no relevant interests were disclosed
Pamela López‐Vargas: no relevant interests were disclosed
Edoardo Melilli: no relevant interests were disclosed
Sergi Codina: no relevant interests were disclosed
Ana Royuela: no relevant interests were disclosed
Ana Coloma López: no relevant interests were disclosed
Alexandre Favà: no relevant interests were disclosed
Anna Manonelles: no relevant interests were disclosed
Núria Lloberas: no relevant interests were disclosed
Carlos Couceiro: no relevant interests were disclosed
Josep M Cruzado: no relevant interests were disclosed
Nuria Montero: no relevant interests were disclosed
Update of
- doi: 10.1002/14651858.CD014855
References
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Asher 2014 {published data only}
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ASSET 2012 {published data only}
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- Hames H, Shields AR, Yanqui E, Christianson A, Kremer J, Govil A, et al. Five-year follow-up from a prospective, randomized trial of belatacept-based, CNI free/early steroid withdrawal regimens [abstract]. American Journal of Transplantation 2022;22(Suppl 3):511. [EMBASE: 639186395]
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- Kaufman DB, Shields AR, Leone JP, Wiseman A, Matas AJ, West-Thielke P, et al. A prospective randomized multicenter trial (BEST trial) of belatacept-based C N I-and corticosteroid-free immunosuppression: final two year results [abstract]. American Journal of Transplantation 2019;19(Suppl 3):449. [EMBASE: 628453782]
Bromberg 2011 {published data only}
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- Bromberg J, Cibrik D, Steinberg S, West-Thielke P, Yang H, Erdman J, et al. A phase 2 study to assess the safety and efficacy of alefacept (ALEF) in de novo kidney transplant recipients [abstract]. American Journal of Transplantation 2011;11(Suppl 2):190. [EMBASE: 70405566]
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- Cibrik D, Steinberg S, West P, Yang H, Bromberg J, Erdman J, et al. A phase 2 study to assess the safety and efficacy of alefacept (ALEF) in de novo kidney transplant recipients [abstract]. Transplant International 2011;24(Suppl 2):70. [EMBASE: 70527323]
Budde 2007 {published data only}
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- Budde K, Bosmans J, Zeier M, Sennesael J, Hopt U, Fischer WH, et al. Safety and efficacy of reduced or full dose of cyclosporine (neoral®) in combination with mycophenolate sodium (myfortic®), basiliximab (simulect®), and steroids in de novo kidney transplant recipients [abstract no: O212]. Transplantation 2004;78(2 Suppl):83.
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- Budde K, Bosmans JL, Sennesael J, Zeier M, Hopt U, Fischer W, et al. Reduced cyclosporine exposure is safe and efficacious in combination with basiliximab, enteric-coated mycophenolate-sodium, and steroids [abstract no: 1195]. American Journal of Transplantation 2005;5(Suppl 11):461. [CENTRAL: CN-0064416]
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- Budde K, Bosmans JL, Sennesael J, Zeier M, Pisarski P, Schutz M, et al. Reduced-exposure cyclosporine is safe and efficacious in de novo renal transplant recipients treated with enteric-coated mycophenolic acid and basiliximab. Clinical Nephrology 2007;67(3):164-75. [MEDLINE: ] - PubMed
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- Budde K, Zeier M, Bosmans JL, Sennesael J, Glander P, Fischer W, et al. Reduced-exposure cyclosporine is safe and efficacious in de novo renal transplant recipients treated with enteric-coated mycophenolic acid and basiliximab [abstract no: F-PO1088]. Journal of the American Society of Nephrology 2006;17(Abstracts):565A. - PubMed
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- Budde K, Zeier M, Cohen D, Kirchherr B, MyProms SG. How much exposure is needed in the first week in patients receiving induction with basiliximab and enteric coated mycophenolate sodium? [abstract no: 1206]. American Journal of Transplantation 2005;5(Suppl 11):464. [CENTRAL: CN-00602063]
Burkhalter 2012 {published data only}
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- Burkhalter F, Oettl T, Descoeudres B, Bachmann A, Guerke L, Mihatsch MJ, et al. High incidence of rejection episodes and poor tolerance of sirolimus in a protocol with early steroid withdrawal and calcineurin inhibitor-free maintenance therapy in renal transplantation: experiences of a randomized prospective single-center study. Transplantation Proceedings 2012;44(10):2961-5. [MEDLINE: ] - PubMed
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- Oettl T, Descoeudres B, Burkhalter F, Bachmann A, Gürke L, Mihatsch MJ, et al. An open, single centre, prospective study to investigate a steroid free immunosuppressive regimen for de novo renal transplant recipients followed by a two arm randomisation to a CNI-sparing and a CNI-free maintenance immunosuppression after 3 months [abstract no: 38]. Swiss Medical Weekly 2008;138(Suppl 167):15S. [CENTRAL: CN-01657296] [~]
CAESAR 2007 {published data only}
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- Ekberg H, Grinyo J, Nashan B, Vanrenterghem Y, Vincenti F, CAESAR Study Group. Low-dose cyclosporine in conjunction with daclizumab, mycophenolate mofetil and corticosteroids is safe and effective in contrast to early cyclosporine withdrawal [abstract no: 93]. In: 3rd International Congress on Immunosuppression; 2004 Dec 8-11; San Diego (CA). 2004. [CENTRAL: CN-00550672]
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- Ekberg H, Grinyo J, Nashan B, Vanrenterghem Y, Vincenti F, Calleja E, et al. The use of daclizumab and mycophenolate mofetil in combination with corticosteroids and cyclosporine (low dose versus low dose followed by withdrawal) to optimize renal function in recipients of renal allografts [abstract no: P734]. Transplantation 2004;78(2 Suppl):458. [CENTRAL: CN-00509171]
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- Ekberg H, Grinyo J, Nashan B, Vanrenterghem Y, Vincenti F, Voulgari A, et al. Cyclosporine sparing with mycophenolate mofetil, daclizumab and corticosteroids in renal allograft recipients: the CAESAR Study. American Journal of Transplantation 2007;7(3):560-70. [MEDLINE: ] - PubMed
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- Grinyo J, Vanrenterghem Y, Nashan B, Vincenti F, Ekberg H, Spleiss O, et al. Association of three polymorphisms with acute rejection after kidney transplantation: an exploratory pharmacogenetic analysis of a randomized multicenter clinical trial (the CAESAR study) [abstract no: 1020]. American Journal of Transplantation 2006;6(Suppl 2):410. [CENTRAL: CN-00678972]
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- Kuypers DR, Ekberg H, Grinyo J, Nashan B, Vincenti F, Snell P, et al. Mycophenolic acid exposure after administration of mycophenolate mofetil in the presence and absence of cyclosporin in renal transplant recipients. Clinical Pharmacokinetics 2009;48(5):329-41. [MEDLINE: ] - PubMed
Cai 2014 {published data only}
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- Cai L, Zeng F, Liu B, Wei L, Chen Z, Jiang J. A single-centre, open-label, prospective study of an initially short-term intensified dosing regimen of enteric-coated mycophenolate sodium with reduced cyclosporine A exposure in Chinese live-donor kidney transplant recipients. International Journal of Clinical Practice Supplement 2014;68(Suppl 181):23-30. [MEDLINE: ] - PubMed
CAMPASIA 2005 {published data only}
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- Munoz AS, Cabanayan-Casasola CB, Danguilan RA, Padua FB, Ona ET. Campath-1H (alemtuzumab) as an induction agent for the prevention of graft rejection and preservation of renal function in kidney transplant patients: Philippine 3-year follow-up. Transplantation Proceedings 2008;40(7):2230-3. [MEDLINE: ] - PubMed
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- Vathsala A, Ona ET, Tan S, Suresh S, Chan Y, Lou H, et al. CAMPSIA: a pilot randomised controlled trial of the effectiveness of campath-1h (mabcampath®) as an induction agent for prevention of graft rejection and preservation of renal function in patients receiving kidney transplants [abstract no: 908]. American Journal of Transplantation 2004;4(Suppl 8):406. [CENTRAL: CN-00509539]
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- Vathsala A, Ona ET, Tan SY, Suresh S, Lou HX, Cabanayan-Casasola CB, et al. Induction therapy with alemtuzumab together with low dose cyclosporine monotherapy permits steroid-free immunosuppression, mitigates drug-related, non-immune toxicities and improves quality of life [abstract no: TH-PO550]. Journal of the American Society of Nephrology 2006;17(Abstracts):224A.
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- Vathsala A, Ona ET, Tan SY, Suresh S, Lou HX, Cabanayan-Casasola CB, et al. Lymphocyte recovery after depletion by alemtuzumab in renal transplant recipients: impact on outcome [abstract no: 1015]. American Journal of Transplantation 2005;5(Suppl 11):415. [CENTRAL: CN-00644284]
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- Vathsala A, Ona ET, Tan SY, Suresh S, Lou HX, Cabanayan-Casasola CB, et al. Randomized trial of alemtuzumab for prevention of graft rejection and preservation of renal function after kidney transplantation. Transplantation 2005;80(6):765-74. [MEDLINE: ] - PubMed
Chadban 2013 {published data only}
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- Chadban S, Campbell S, Russ G, Walker R, Chapman J, Pussell B, et al. A one-year, randomised, open label, parallel group study to investigate the safety and efficacy of enteric-coated mycophenolate sodium (EC-MPS) in combination with full dose or reduced dose cyclosporine microemulsion (CSA-ME), basiliximab and steroids in de novo kidney transplantation [abstract no: 32]. In: Transplantation Society of Australia & New Zealand (TSANZ). 24th Annual Scientific Meeting; 2006 Mar 29-31; Canberra (ACT). 2006:51. [CENTRAL: CN-00583470]
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- Chadban S. Enteric-coated mycophenolate sodium in combination with full dose or reduced dose cyclosporine, basiliximab and corticosteroids in Australian de novo kidney transplant patients. Nephrology 2013;18(1):63-70. [MEDLINE: ] - PubMed
Chan 2008 {published data only}
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- Chan L, Greenstein S, Hardy MA, Hartmann E, Bunnapradist S, Cibrik D, et al. Multicenter, randomized study of the use of everolimus with tacrolimus after renal transplantation demonstrates its effectiveness. Transplantation 2008;85(6):821-6. [MEDLINE: ] - PubMed
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- Chan L, Hartmann E, Cibrik D, Cooper M, Shaw LM. Everolimus (RAD001) concentration is associated with risk reduction for acute rejection in de novo renal transplant recipients [abstract no: SA-PO2529]. Journal of the American Society of Nephrology 2008;19(Abstracts Issue):678A.
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- Chan L, Hartmann E, Cibrik D, Cooper M, Shaw LM. Optimal everolimus concentration is associated with risk reduction for acute rejection in de novo renal transplant recipients. Transplantation 2010;90(1):31-7. [MEDLINE: ] - PubMed
Chan 2012 {published data only}
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- Andres A, Bloom R, Bunnapradist S, Cassuto E, Chan L, Hart M, et al. Randomized, multicenter study of the safety and efficacy of enteric-coated mycophenolate sodium combined with basiliximab and low or standard dose of tacrolimus in de novo renal transplant patients [abstract no: 507]. Transplant International 2007;20(Suppl 2):217.
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- Asderakis A, Chan L. Renal function with enteric-coated mycophenolate sodium in combination with reduced and standard tacrolimus levels: results of a 6-month study in de novo renal transplant recipients [abstract no: O111]. In: British Transplantation Society (BTS).12th Annual Congress; 2009 Apr 21-24; Liverpool, UK. 2009. [CENTRAL: CN-01657257]
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- Chan L, Hart M, Andres A, Gugliuzza K, Bunnapradist S, Parasumaran R. Renal function and incidence of NODM with enteric-coated mycophenolate sodium in combination with reduced and standard tacrolimus levels: results of a 6-month comparative study in de novo renal transplant recipients [abstract no: 718]. Transplantation 2008;86(2S):251. [CENTRAL: CN-01657259]
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- Nicholson ML, Chan L. Incidence of new onset diabetes mellitus in de novo renal transplant recipients treated with enteric-coated mycophenolate sodium in combination with reduced or standard tacrolimus target levels: Results of a 6-month randomized study [abstract no: P266]. In: British Transplantation Society (BTS).12th Annual Congress; 2009 Apr 21-24; Liverpool, UK. 2009. [CENTRAL: CN-01657260]
Cibrik 2007 {published data only}
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- Bresnahan B, Cibrik D, Jensik S, Whelchel J, Klintmalm G, Cohen D, et al. Treatment of high-risk renal transplant recipients with EC-MPS (Myfortic®) is safe and efficacious [abstract no: PUB216]. Journal of the American Society of Nephrology 2005;16(Abstracts):829A.
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- Budde K, Zeier M, Cohen D, Kirchherr B, MyProms Study Group. How much exposure is needed in the first week in patients receiving induction with basiliximab and enteric coated mycophenolate sodium? [abstract no: 1206]. American Journal of Transplantation 2005;5(Suppl 11):464. [CENTRAL: CN-00602063]
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- Cibrik D, Jensik S, Bresnahan B, Whelchel J, Klintmalm G, ERL2405-US01 Study Group. Safety and efficacy of EC-MPS in combination with simulect and neoral in de novo renal transplant high-risk recipients [abstract no: 135]. American Journal of Transplantation 2005;5(Suppl 11):190. [CENTRAL: CN-00644170]
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- Cibrik D, Jensik S, Meier-Kriesche H, Bresnahan B, Lieberman B, Myfortic US01 Renal Transplant Group. Enteric-coated mycophenolate sodium in combination with optimized neoral dosing, basiliximab, and steroids results in good efficacy and renal function in renal transplant recipients in the first six months [abstract no: 220]. American Journal of Transplantation 2004;4(Suppl 8):218. [CENTRAL: CN-00644278]
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- Cibrik D, Meier-Kriesche HU, Bresnahan B, Wu YM, Klintmalm G, Kew CE, et al. Renal function with cyclosporine C2 monitoring, enteric-coated mycophenolate sodium and basiliximab: a 12-month randomized trial in renal transplant recipients. Clinical Transplantation 2007;21(2):192-201. [MEDLINE: ] - PubMed
CIS 2014 {published data only}
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- Sommerer C, Brocke J, Bruckner T, Schaier M, Morath C, Meuer S, et al. Improved pulse wave velocity and renal function in individualized calcineurin-inhibitor treatment by immunomonitoring: the randomized controlled Calcineurin Inhibitor-Sparing (CIS) Trial. Transplantation 2018;102(3):510-20. [MEDLINE: ] - PubMed
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- Sommerer C, Brocke J, Meuer S, Zeier MG, Giese T. Monitoring of ciclosporin by NFAT-regulated gene expression reduces the cardiovascular risk- the CIS trial [abstract no: FR-PO1077]. Journal of the American Society of Nephrology 2015;26(Abstract Suppl):617A. [EMBASE: 641101251]
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- Sommerer C, Schaier M, Morath C, Schwenger V, Rauch G, Giese T, et al. The Calcineurin Inhibitor-Sparing (CIS) Trial - individualised calcineurin-inhibitor treatment by immunomonitoring in renal allograft recipients: protocol for a randomised controlled trial. Trials [Electronic Resource] 2014;15:489. [MEDLINE: ] - PMC - PubMed
Cockfield 2019 {published data only}
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- Cockfield S, Rush D, Jevnikar A, Paquet M, Prasad G, Howell J. Standard vs. low dose extended-release tacrolimus (Advagraf) in de novo renal transplant: 6-month interim analysis [abstract]. Transplantation 2014;98(Suppl 1):685. [EMBASE: 71545865]
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- Cockfield S, Rush D, Wilson S, Howell J. Impact of antihypertensive (AHT) choice and Advagraf dose on interstitial fibrosis/tubular atrophy (IF/TA) and IF/TA progression in renal allografts 24 months post-transplantation (Tx) [abstract]. American Journal of Transplantation 2017;17(Suppl 3):231. [EMBASE: 615704881]
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- Cockfield SM, Wilson S, Campbell PM, Cantarovich M, Gangji A, Houde I, et al. Comparison of the effects of standard vs low-dose prolonged-release tacrolimus with or without ACEi/ARB on the histology and function of renal allografts. American Journal of Transplantation 2019;19(6):1730-44. [MEDLINE: ] - PMC - PubMed
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- Rush D, Cockfield S, Wilson S, Howell J. Impact of antihypertensive (AHT) choice and Advagraf dose on immunologic events in renal allografts 24 months post-transplantation (Tx) [abstract]. American Journal of Transplantation 2017;17(Suppl 3):231. [EMBASE: 615704915]
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- Rush D, Cockfield S, Wilson S, Schwartz J. Long-term impact of antihypertensive treatment and tacrolimus dose in renal allograft recipients 5 years post-transplantation [abstract]. American Journal of Transplantation 2019;19(Suppl 3):966. [EMBASE: 628453151]
CRADLE 2018 {published data only}
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- Christian M, Bjerre A, Wennberg L, Ettenger R, Pape L, Tonshoff B, et al. Design and baseline characteristics of CRADLE: A study evaluating the efficacy and safety of everolimus to reduce CNI exposure and to withdraw steroids in pediatric renal transplant recipients [abstract no: P226]. Pediatric Nephrology 2014;29(9):1755. [EMBASE: 71662623]
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- Ettenger R, Tonshoff B, Tedesco-Silva H, Dello Strologo L, Marks S, Pape L, et al. Efficacy and safety of everolimus with reduced-exposure tacrolimus and corticosteroid withdrawal in de novo pediatric renal transplant recipients: 12-month results from the CRADLE study [abstract]. American Journal of Transplantation 2017;17(Suppl 3):407-8. [EMBASE: 615705896]
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- Gupta D. Design of a randomized study evaluating everolimus in pediatric renal transplant recipients [abstract no: P708]. Transplant International 2013;26(Suppl 2):328. [EMBASE: 71360310]
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- Pape L, Tonshoff B, Ettenger R, Dello SL, Martzloff ED, Ng J, et al. Rationale, design and baseline characteristics of pediatric renal transplant recipients in CRADLE study: a randomised study to evaluate the effect of early everolimus initiation to reduce calcineurin inhibitor exposure and to withdraw steroid [abstract]. Pediatric Nephrology 2015;30(9):1712. [EMBASE: 72033676]
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- Strologo LD, Tonshoff B, Pape L, Ettenger R, Niaudet P, Martzloff ED, et al. Rationale and design of a study evaluating the efficacy and safety of early conversion of calcineurin inhibitor to everolimus in paediatric renal transplant recipients [abstract no: P376]. Pediatric Nephrology 2012;27(9):1816. [EMBASE: 71386594]
David‐Neto 2014 {published data only}
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- David-Neto E, Galante N, Altona M, Paula F, Triboni A, Ramos F, et al. A randomized, prospective study comparing everolimus/low tacrolimus with regular tacrolimus/MPS for the elderly renal transplant recipients [abstract]. Transplantation 2014;98(Suppl 1):549. [EMBASE: 71545379]
de Sevaux 2001 {published data only}
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- Smak Gregoor PJH, Sevaux RGL, Hene RJ, Hilbrands LB, Gelder T, Hoitsma AJ, et al. The cyclosporine sparing effect of mycophenolate mofetil, a randomized study [abstract]. Journal of the American Society of Nephrology 1998;9(Program & Abstracts):699A. [CENTRAL: CN-00447776]
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- Sevaux RG, Gregoor PJ, Hene RJ, Hoitsma AJ, Vos P, Weimar W, et al. A controlled trial comparing two doses of cyclosporine in conjunction with mycophenolate mofetil and corticosteroids. Journal of the American Society of Nephrology 2001;12(8):1750-7. [MEDLINE: ] - PubMed
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- Sevaux RG, Smak Gregoor PJ, Hene RJ, Hoitsma AJ, Vos P, et al. Addition of mycophenolate mofetil to cyclosporine and prednisone allows for a lower dose of cyclosporine after renal transplantation [abstract]. In: XVIII International Congress of the Transplantation Society; 2000 Aug 27-Sep 1; Rome, Italy. 2000. [CENTRAL: CN-00583239]
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- Sévaux RG, Smak Gregoor PJ, Hené RJ, Weimar W, Hoitsma AJ, Van Gelder T, et al. A randomised study of conventional vs low dose cyclosporine in renal transplant recipients treated with cyclosporine, mycophenolate mofetil and prednisone [abstract no: 418]. Transplantation 1998;65(12):S107. [CENTRAL: CN-00583548]
DICAM 2010 {published data only}
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- Etienne I, Toupance O, Benichou J, Thierry A, Al Najjar A, Hurault dL, et al. A 50% reduction in cyclosporine exposure in stable renal transplant recipients: renal function benefits. Nephrology Dialysis Transplantation 2010;25(9):3096-106. [MEDLINE: ] - PubMed
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- Etienne I, Toupance O, Thierry A, Al NA, De Ligny HB, Rerolle J, et al. Impact of two years of 50% reduction of cyclosporine exposure in stable kidney transplant recipients treated with mycophenolate mofetil without corticosteroids on renal function: Results at 60 months of follow-up of a multicenter randomized controlled trial: The DICAM study [abstract]. American Journal of Transplantation 2011;11(Suppl 2):410. [EMBASE: 70406352]
EVEREST 2009 {published data only}
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- Citterio F, Scolari MP, Salvadori M, Castagneto M, Rigotti P, Albertazzi A, et al. A randomized trial comparing standard everolimus plus cyclosporine with higher blood everolimus levels plus very low cyclosporine levels in renal transplant recipients: preliminary results of the Everest Study [abstract no: P118]. Transplant International 2007;20(Suppl 2):124. [CENTRAL: CN-00724884]
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- Corbetta G, Salvadori M, Scolari MP, Citterio F, Rigotti P, Cossu M, et al. Exposure to everolimus, and not to cyclosporine, is associated with freedom from acute rejection in de novo renal recipients [abstract no: 447]. Transplantation 2008;86(Suppl 2):157. [CENTRAL: CN-00740485]
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- Ponticelli C, Salvadori M, Scolari MP, Citterio F, Rigotti P, Veneziano A, et al. Everolimus and minimization of cyclosporine in renal transplantation: 24-month follow-up of the EVEREST study. Transplantation 2011;91(10):e72-3. [MEDLINE: ] - PubMed
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- Salvadori M, Scolari M, Bertoni E, Citterio F, Rigotti P, Cossu M, et al. Targeting upper everolimus blood levels with very low-dose cyclosporine is effective and safe in de novo renal transplantation [abstract no: 448]. Transplantation 2008;86(Suppl 2):158. [CENTRAL: CN-00740453]
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- Salvadori M, Scolari MP, Bertoni E, Citterio F, Rigotti P, Cossu M, et al. Everolimus with very low-exposure cyclosporine A in de novo kidney transplantation: a multicenter, randomized, controlled trial. Transplantation 2009;88(10):1194-202. [MEDLINE: ] - PubMed
Fangmann 2010 {published data only}
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- Fangmann J, Arns W, Marti H, Budde K, Beckurts T, Hauss J. Low dose cyclosporine regimen with daclizumab induction and mycophenolate mofetil after kidney transplantation - impact on renal function and rejection episodes [abstract no: 113]. American Journal of Transplantation 2005;5(Suppl 11):185. [CENTRAL: CN-00644197]
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- Fangmann J, Arns W, Marti H, Budde K, Neumayer H, Beckurts T, et al. Impact of daclizumab and low dose cyclosporine in combination with mycophenolate mofetil and steroids on renal function after kidney transplantation [abstract no: 715]. American Journal of Transplantation 2004;4(Suppl 8):353. [CENTRAL: CN-00509182]
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- Fangmann J, Arns W, Marti H, Budde K, Neumayer H, Beckurts T, et al. Impact of daclizumab and low dose cyclosporine in combination with mycophenolate mofetil and steroids on renal function after kidney transplantation [abstract no: P249]. Transplantation 2004;78(2 Suppl):280. [CENTRAL: CN-01912449]
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- Fangmann J, Arns W, Marti HP, Hauss J, Ketteler M, Beckurts T, et al. Impact of daclizumab, low-dose cyclosporine, mycophenolate mofetil and steroids on renal function after kidney transplantation. Nephrology Dialysis Transplantation 2010;25(1):283-92. [MEDLINE: ] - PubMed
Ferguson 2006 {published data only}
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- Ferguson R, Mulgaonkar S, Tedesco Silva H, Oppenheimer F, Walker R, et al. FTY720 with reduced-exposure (R-E) cyclosporine [neoral] (CsA): acute rejection prophylaxis in de novo renal transplant (Tx) recipients [abstract]. In: Transplantation Society of Australia & New Zealand (TSANZ). 21st Annual Scientific Meeting; 2003 Apr 9-11; Canberra (ACT). 2003:63. [CENTRAL: CN-00509182]
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- Ferguson RM, Mulgaonkar S, Tedesco H, Oppenheimer F, Walker R, Kunzendor U, et al. FTY720 with reduced-exposure neoral provides adequate rejection prophylaxis in de novo renal transplant recipients. Interim results [abstract no: 0049]. In: XIXth International Congress of the Transplantation Society; 2002 Aug 25-30; Miami (FL). 2002. [CENTRAL: CN-00415638]
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- Ferguson RM, Mulgaonkar S, Tedesco H, Oppenheimer F, Walker R, Russ G, et al. High efficacy of FTY720 with reduced cyclosporine dose in preventing rejection in renal transplantation: 12-month preliminary results [abstract no: 624]. American Journal of Transplantation 2003;3(Suppl 5):311. [CENTRAL: CN-00445316]
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- Mulgaonkar S, Tedesco H, Oppenheimer F, Walker R, Kunzendorf U, Russ G, et al. FTY720/cyclosporine regimens in de novo renal transplantation: a 1-year dose-finding study. American Journal of Transplantation 2006;6(8):1848-57. [MEDLINE: ] - PubMed
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- Russ G, Ferguson RM, Mulgaonkar S, Tedesco-Silva H, Oppenheimer F, Walker R, et al. FTY720 with reduced dose Neoral (RDN) may offer a safety/tolerability profile advantage over conventional immunosuppressive therapies [abstract no: 1000]. American Journal of Transplantation 2004;4(Suppl 8):432. [CENTRAL: CN-00509451]
Fleming 2016 {published data only}
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- Fleming J, Taber D, Pilch N, Meadows H, Mardis C, McGillicuddy J, et al. mTOR-based CNI minimization vs withdrawal in African American kidney transplant recipients [abstract]. American Journal of Transplantation 2015;15(Suppl 3):D140. [EMBASE: 71953883]
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- Fleming JN, Taber DJ, Pilch NA, McGillicuddy JW, Srinivas TR, Baliga PK, et al. A randomized, prospective comparison of transition to sirolimus-based CNI-minimization or withdrawal in African American kidney transplant recipients. Clinical Transplantation 2016;30(5):528-33. [MEDLINE: ] - PubMed
Fricke 2009 {published data only}
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- Fricke L, Meier M, Bode W, Wong W, Lehnert H, Steinhoff J, et al. Low dose immunosuppression is not sufficient to avoid acute rejections in old for old kidney transplant recipients: a one year prospective multicenter randomized controlled trial [abstract no: P-384]. Transplant International 2009;22(Suppl 2):190.
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- Meier M, Bode W, Nitschke M, Wong W, Kramer J, Lehnert H, et al. Low does tacrolimus versus mycophenolate-mofetil in "old for old" kidney transplantation: a one year prospective multicenter randomized controlled trial [abstract no: 1090]. American Journal of Transplantation 2009;9(Suppl 2):498.
Ghadimi 2018 {published data only}
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- Ghadimi M, Dashti-Khavidaki S, Khatami MR, Mahdavi-Mazdeh M, Gatmiri M, Minoo FS, et al. Comparing the effect of immediate versus delayed initiation of tacrolimus on delayed graft function in kidney transplant recipients: a randomized open-label clinical trial. Journal of Research in Pharmacy Practice 2018;7(2):69-76. [MEDLINE: ] - PMC - PubMed
Ghafari 2007 {published data only}
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- Ghafari A, Makhdoomi K, Ahmadpoor P, Afshari AT, Farshid B, Fallah MM, et al. Mycophenolate mofetil (MMF) plus low dose versus high dose cyclosporine A (CSA) induction protocols in renal transplantation [abstract no: T-PO50034]. Nephrology 2005;10(Suppl):A216. [CENTRAL: CN-01657299]
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- Ghafari A, Makhdoomi K, Ahmadpoor P. Early low dose versus high dose cyclosporine A (CSA) induction protocols in renal transplantation [abstract no: SP742]. Nephrology Dialysis Transplantation 2006;21(Suppl 4):iv265. [CENTRAL: CN-01657300] - PubMed
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- Ghafari A, Makhdoomi K, Ahmadpour P, Afshari AT, Fallah MM, Rad PS. Low-dose versus high-dose cyclosporine induction protocols in renal transplantation. Transplantation Proceedings 2007;39(4):1219-22. [MEDLINE: ] - PubMed
HERAKLES 2018 {published data only}
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- Sommerer C, Duerr M, Witzke O, Lehner F, Arns W, Kliem V, et al. Five-year outcomes in kidney transplant patients randomized to everolimus with cyclosporine withdrawal or low-exposure cyclosporine versus standard therapy. American Journal of Transplantation 2018 May 2;18(12):2965-76. [MEDLINE: ] - PubMed
IRCT201604253043N11 {published data only}201604253043N11
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- IRCT201604253043N. Comparing the starting time of tacrolimus administration in management of kidney transplant recipients. https://trialsearch.who.int/Trial2.aspx?TrialID=IRCT201604253043N11 2016.
Jindal 2002 {published data only}
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- Jardine A. 12 month results of a phase III prospective, randomised study to evaluate concentration controlled rapamune with cyclosporin dose minimization or eliminiation in de novo renal allograft recipient [abstract no: 1206]. American Journal of Transplantation 2003;3(Suppl 5):461. [CENTRAL: CN-00445901] - PubMed
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- Jardine AG. Phase III prospective, randomized study to evaluate the safety and efficacy of concentration controlled rapamune (sirolimus) with ciclosporin dose minimisation or elimination in de novo renal allograft recipients at 12 months [abstract no: 464]. American Journal of Transplantation 2004;4(Suppl 8):286. [CENTRAL: CN-00520346]
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- Jindal RM, UK and Ireland Rapamune Study Group. A phase III prospective, randomised study to evaluate concentration controlled rapamune with cyclosporin dose minimization or elimination at six months in de novo renal allograft recipients [abstract no: 0436]. In: XIXth International Congress of the Transplantation Society; 2002 Aug 25-30; Miami (FL). 2002. [CENTRAL: CN-00415940] - PubMed
Kamar 2012 {published data only}
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- Kamar N, Mariat C, Albano L, Villemain F, Moal MC, Ladriere M, et al. Improvement in renal function following conversion from low-dose mycophenolate acid to higher-dose enteric-coated mycophenolate sodium (EC-MPS) with concomitant tacrolimus reduction in maintenance kidney transplant recipients [abstract no: O-295]. Transplant International 2009;22(Suppl 2):78. [CENTRAL: CN-01657134]
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- Kamar N, Rostaing L, Cassuto E, Villemain F, Moal MC, Ladriere M, et al. A multicenter, randomized trial of increased mycophenolic acid dose using enteric-coated mycophenolate sodium with reduced tacrolimus exposure in maintenance kidney transplant recipients. Clinical Nephrology 2012;77(2):126-36. [MEDLINE: ] - PubMed
Lee 2017 {published data only}
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- Oh CK, Lee SH, Kim MS, Kim SJ, Ha J. Cyclosporine sparing effect of entericcoated mycophenolate sodium in de novo kidney transplantation [abstract]. Transplant International 2015;28(Suppl 4):374. [EMBASE: 72112145]
Liu 2007b {published data only}
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- Liu M, Zhang W, Gu M, Yin C, Zhang WY, Lv Q, et al. Protective effects of sirolimus by attenuating connective tissue growth factor expression in human chronic allograft nephropathy. Transplantation Proceedings 2007;39(5):1410-5. [MEDLINE: ] - PubMed
Lo 2003 {published data only}
-
- Gaber AO, Egidi MF, Lo A, Gaber LW, Shokouh-Amiri MH, Grewal HP, et al. Defining the optimal doses of sirolimus and tacrolimus in high-risk cadaveric renal transplant recipients [abstract no: 541]. American Journal of Transplantation 2002;2(Suppl 3):274. [CENTRAL: CN-00415690]
-
- Lo A, Egidi MF, Gaber LW, Amiri HS, Vera S, Nezakatgoo N, et al. Comparison of sirolimus-based calcineurin inhibitor-sparing and calcineurin inhibitor-free regimens in cadaveric renal transplantation. Transplantation 2004;77(8):1228-35. [MEDLINE: ] - PubMed
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- Lo A, Egidi MF, Gaber LW, Amiri HS, Vera S, Nezakatgoo N, et al. Comparison of two different rapamycin based immunosuppressive regimens in cadaveric renal transplantation [abstract no: 1205]. American Journal of Transplantation 2003;3(Suppl 5):460-1. [CENTRAL: CN-00446446]
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- Lo A, Egidi MF, Gaber LW, Gaber AO. Observations on the use of sirolimus and tacrolimus in high-risk renal transplant recipients. Transplantation Proceedings 2003;35(3 Suppl):105S-8S. [MEDLINE: ] - PubMed
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- Lo A, Egidi MF, Gaber LW, Shokouh-Amiri MH, Nazakatgoo N, Fisher JS, et al. Observations regarding the use of sirolimus and tacrolimus in high-risk cadaveric renal transplantation. Clinical Transplantation 2004;18(1):53-61. [MEDLINE: ] - PubMed
Maamoun 2010 {published data only}
-
- Maamoun H, Soliman A, Zayed B. Cyclosporine and mycophenolate mofetil 48 hours before renal transplantation enables the use of low cyclosporine doses and achieves better graft function. Transplantation Proceedings 2010;42(10):4033-6. [MEDLINE: ] - PubMed
Maiorano 2006 {published data only}
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- Maiorano A, Stallone G, Schena A, Infante B, Pontrelli P, Schena FP, et al. Sirolimus interferes with iron homeostasis in renal transplant recipients. Transplantation 2006;82(7):908-12. [MEDLINE: ] - PubMed
Margreiter 2008 {published data only}
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- Margreiter R, Klempnauer J, Neuhaus P, Muehlbacher F, Boesmueller C, Calne RY. Alemtuzumab (Campath-1H) and tacrolimus monotherapy after renal transplantation: results of a prospective randomized trial. American Journal of Transplantation 2008;8(7):1480-5. [MEDLINE: ] - PubMed
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- Margreiter R, Klempnauer J, Neuhaus P, Muehlbacher F. Alemtuzumab (Campath-1H) induction followed by tacrolimus monotherapy vs tacrolimus based triple drug immunosuppression in cadaveric renal transplantation - results of a multicenter trial [abstract no: 333]. American Journal of Transplantation 2007;7(Suppl 2):234. [CENTRAL: CN-00644175]
MODIFY 2012 {published data only}
-
- David-Neto E, Lemos FC, Souza PS, Ventura CG, Castro MCR, Agena F, et al. Five-year follow-up of the MoDIFY Study (Modification of Doses to Improve Function through the Years) shows benefit of low tacrolimus and regular MMF doses [abstract no: 1655]. American Journal of Transplantation 2010;10(Suppl 4):508. [EMBASE: 70465030]
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- David-Neto E, Pereira LM, Castro MCR, Mattos RM, Sumita NM, Mendes E, et al. Interim analysis of the MODIFY study in renal transplantation [abstract no: P243]. Transplantation 2004;78(2 Suppl):278-9. [CENTRAL: CN-00509408]
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- David-Neto E, Pereira LM, Castro MCR, Mattos RM, Sumita NM, Mendes E, et al. Therapeutic levels of mycophenolic acid under fixed doses of MMF on the first two months after kidney transplantation [abstract no: P242]. Transplantation 2004;78(2 Suppl):278. [CENTRAL: CN-00509409]
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- David-Neto E, Pereira LM, Castro CR, Mattos RM, Sumita NM, Mendes ME, et al. Interim analysis of the MODIFY study in renal transplantation (Modification of Doses to Improve Function through the Years) [abstract no: 279]. American Journal of Transplantation 2004;4(Suppl 8):234-5. [CENTRAL: CN-00509150]
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- David-Neto E, Pereira LM, Castro MCR, Mattos RM, Ventura CG, Sumita NM, et al. Therapeutic levels of mycophenolic acid under fixed doses of MMF on the first two months after kidney transplantation [abstract no: 353]. American Journal of Transplantation 2004;4(Suppl 8):255. [CENTRAL: CN-00509409]
Muhlbacher 2014 {published data only}
-
- Muehlbacher F, Neumayer HH, Castillo D, Stefoni S, the European Sirolimus CsA Minimisation Study Group. An open-label study to evaluate the efficacy & safety of cyclosporine reduction in de novo renal allograft recipients receiving sirolimus: a dose comparative study [abstract no: 1224]. American Journal of Transplantation 2003;3(Suppl 5):465. [CENTRAL: CN-00446852]
-
- Muhlbacher F, Neumayer HH, del CD, Stefoni S, Zygmunt AJ, Budde K, et al. The efficacy and safety of cyclosporine reduction in de novo renal allograft patients receiving sirolimus and corticosteroids: results from an open-label comparative study. Transplant International 2014;27(2):176-86. [MEDLINE: ] - PubMed
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- Muhlbacher F, Paczek L. An open-label study to evaluate the efficacy & safety of cyclosporine reduction in de novo renal allograft recipients receiving sirolimus: a dose comparative study [abstract no: 399]. American Journal of Transplantation 2002;2(Suppl 3):238. [CENTRAL: CN-01912355]
-
- Neumayer H, Muhlbacher F, Stefoni S, Del Castillo D, Myfortic Maintenance Renal Transplantation Study Group. An open-label study to evaluate the efficacy & safety of cyclosporine reduction in de novo renal allograft recipients receiving sirolimus: a dose comparative study [abstract]. In: XIXth International Congress of the Transplantation Society; 2002 Aug 25-30; Miami (FL). 2002. [CENTRAL: CN-00416320]
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- Neumayer HH, Muehlbacher F, Castillo D, Stefoni S, the European Sirolimus CsA Minimisation Study Group. An open-label study to evaluate the efficacy & safety of cyclosporine reduction in de novo renal allograft recipients receiving sirolimus: a dose comparative study [abstract no: W738]. Nephrology Dialysis Transplantation 2003;18(Suppl 4):785.
Nashan 2004 {published data only}
-
- Curtis J, Nashan B, Kovarik J, Ponticelli C, Mourad G, Figueiredo J, et al. RAD (everolimus) pharmacokinetics are unaltered with full-dose versus reduced-dose cyclosporine [abstract no: 516]. American Journal of Transplantation 2001;1(Suppl 1):299. [CENTRAL: CN-01658116]
-
- Curtis J, Nashan B, Poniicelli C, Mourad G, Boger R, RAD 156SG. One year result of a multicenter, open-label trial on safety and efficacy of certican (RAD) used in combination with simulect, corticosteroids, and full or reduced dose neoral in renal transplant [abstract no: 1335]. American Journal of Transplantation 2001;1(Suppl 1):474. [CENTRAL: CN-00444958]
-
- Curtis J, Nashan B, Ponticelli C, Mourad G, Boger R, RAD 156 Study Group. Everolimus (RAD) in combination with reduced dose with reduced dose neoral® maintains effective immunosuppression with improved tolerability compared to full dose neoral [abstract no: A4625]. Journal of the American Society of Nephrology 2001;12(Program & Abstracts):884A. [CENTRAL: CN-00550720]
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- Curtis J, Nashan B, Ponticelli C, Mourad G, Cambon N, Boger R, et al. Multicenter, open-label study of the long-term safety and efficacy of RAD used in combination with simulect, corticosteroids and neoral in renal transplantation (RT): 6 month results [abstract no: A3602). Journal of the American Society of Nephrology 2000;11(Abstracts):685A. [CENTRAL: CN-01658115]
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- Mourad G, Boger R, Curtis J, Nashan B, Ponticelli C, RAD B 156 Study Group. CERTICAN (TM) (RAD; EVEROLIMUS), the proliferation signal inhibitor, is complementary with a reduced dose NEORAL® based quadruple immunosuppressive regimen [abstract no: 1622]. In: A Transplant Odyssey; 2001 Aug 20-23; Istanbul, Turkey. 2001. [CENTRAL: CN-00487738]
NCT00470665 {published data only}
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- NCT00470665. Study comparing sirolimus/prograf vs sirolimus/CsA in high-risk renal transplant recipients. https://clinicaltrials.gov/show/NCT00470665 2007.
NCT00681213 {published data only}
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- NCT00681213. Tacrolimus/sirolimus versus tacrolimus/mycophenolate mofetil (MMF) versus Neoral/sirolimus in adult, primary kidney transplantation. https://clinicaltrials.gov/show/NCT00681213 2008.
NCT01895049 {published data only}
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- NCT01895049. Comparison between two tacrolimus-based immunosuppressant regimens and induction with thymoglobulin in kidney transplants from deceased donors with expanded criteria. https://clinicaltrials.gov/show/NCT01895049 2013.
NCT03644485 {published data only}
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- NCT03644485. Clinical outcome of delayed or standard prograf together with induction therapy followed by conversion to Advagraf in donation after cardiac (or circulatory) death (DCD) kidney transplant recipients. https://clinicaltrials.gov/show/NCT03644485 2018.
NEVERWOUND 2020 {published data only}
-
- Carmellini M, Boschiero L, Rigotti P, Sandrini S, Frasca GM, Minetti E, et al. Immediate introduction of everolimus does not affect wound healing and delayed graft function in kidney transplant recipients: 12-months results from NEVERWOUND study [abstract]. Transplant International 2017;20(Suppl 2):252. [EMBASE: 618770335]
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- Carmellini M, Ruggieri G, Sforza D, Veroux M, Secchi A, Todeschini P, et al. Immediate introduction of everolimus does not affect wound healing and delayed graft function in renal transplant patients: preliminary results from NEVERWOUND study [abstract]. Transplantation 2014;98(Suppl 1):615. [EMBASE: 71545620]
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- Carmellini M, Todeschini P, Secchi A, Sandrini S, Minetti E, Furian L, et al. Immediate introduction of everolimus does not affect wound healing and delayed graft function in kidney transplant recipients: 3-months results from NEVERWOUND study [abstract]. American Journal of Transplantation 2016;16(Suppl 3):228. [EMBASE: 611699536]
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- Manzia TM, Carmellini M, Todeschini P, Secchi A, Sandrini S, Minetti E, et al. A 3-month, multicenter, randomized, open-label study to evaluate the impact on wound healing of the early [vs. delayed] introduction of everolimus in de novo kidney transplant recipients, with a follow-up evaluation at 12 month after transplant (NEVERWOUND study). Transplantation 2020;104(2):374-86. [MEDLINE: ] - PMC - PubMed
Novoa 2011 {published data only}
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- Grinyo JM, Paul J, Novoa P, Errasti P, Franco A, Aldana G, et al. Better renal function in renal-transplant recipients treated with everolimus plus CSA elimination compared with CSA reduction [abstract no: P-359]. Transplant International 2009;22(Suppl 2):183. [CENTRAL: CN-01657137]
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- Grinyo JM, Paul J, Novoa P, Errasti P, Franco A, Aldana G, et al. Better renal function in renal-transplant recipients treated with everolimus plus cyclosporine elimination compared with cyclosporine minimisation [abstract no: 1636]. American Journal of Transplantation 2010;10(Suppl 4):503. [EMBASE: 70465011]
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- Novoa PA, Grinyo JM, Ramos FJP, Errasti P, Franco A, Aldana G, et al. De novo use of everolimus with elimination or minimization of cyclosporine in renal transplant recipients. Transplantation Proceedings 2011;43(9):3331-9. [MEDLINE: ] - PubMed
Oh 2015 {published data only}
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- Oh CK, Ha JW, Kim YH, Kim YL, Kim YS. Safety and efficacy of the early introduction of everolimus (Certican) with low dose of cyclosporine in de novo kidney recipients after 1 month of transplantation (Preliminary results). Journal of the Korean Society for Transplantation 2012;26(2):83-91. [CENTRAL: CN-01046131]
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- Oh CK, Huh KH, Ha J, Kim YH, Kim YL, Kim YS. Safety and efficacy of the early introduction of everolimus with reduced-exposure cyclosporine A in de novo kidney recipients. Transplantation 2015;99(1):180-6. [MEDLINE: ] - PubMed
OPTICEPT 2009 {published data only}
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- Bloom R, Kaplan B, Meier-Kriesche H, Shaw L, Shah T, Patel D, et al. Opticept Trial: efficacy and safety of monitored MMF in combination with CNI in renal transplantation at 1 and 2 years [abstract no: 862]. Transplantation 2008;86(2 Suppl):301. [CENTRAL: CN-00740509]
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- Gaston R, Bloom R, Shah T, Cibrik D, Angelis M, Mulgaonkar S, et al. 6-month outcomes of monitored mycophenolate mofetil (MMF) in combination with calcineurin inhibitors (CNI) in renal allograft recipients: an interim analysis of the OPTICEPT trial [abstract no: TH-PO565]. Journal of the American Society of Nephrology 2006;17(Abstracts):228A.
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- Gaston R, Kaplan B, Meier-Kriesche H, Shaw L, Shah T, Patel D, et al. Opticept Trial: efficacy and safety of monitored MMF in combination with CNI in renal transplantation at 12 months [abstract no: 526]. American Journal of Transplantation 2008;8(Suppl 2):319. [CENTRAL: CN-00653708]
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- Gaston RS, Kaplan B, Shah T, Cibrik D, Shaw LM, Angelis M, et al. Fixed- or controlled-dose mycophenolate mofetil with standard- or reduced-dose calcineurin inhibitors: the OPTICEPT trial. American Journal of Transplantation 2009;9(7):1607-19. [MEDLINE: ] - PubMed
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- Kaplan B, Gaston R, Meier-Kriesche H, Bloom R, Patel D, Shaw L. Mycophenolate mofetil may require dose modification based on weight: an analysis of MPA exposure in the OptiCept Trial [abstract no: 787]. American Journal of Transplantation 2009;9(Suppl 2):419. [CENTRAL: CN-00794654]
OPTIMA‐TX 2008 {published data only}
-
- Bolin P Jr, Shihab F, Mulloy L, Henning A, Gao J, Bartucci M, et al. Optimizing tacrolimus therapy in maintenance renal allografts: 6 month results [abstract no: 390]. American Journal of Transplantation 2006;6(Suppl 2):197-8. [CENTRAL: CN-00671805] - PubMed
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- Bolin P, Mirza R, Sullivan P, Holbert D, Parker K. Optimizing tacrolimus therapy in maintenance renal allografts: a single center assessment of cardiovascular risk factors at 36 months [abstract no: 1632]. Transplantation 2008;86(2S):541. [CENTRAL: CN-01657946]
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- Bolin P, Mirza R, Sullivan P, Holbert D, Parker KR. Optimizing tacrolimus therapy in maintenance renal allografts: a single center assessment of cardiovascular risk factors and renal function at 36 months [abstract no: SA-PO2518]. Journal of the American Society of Nephrology 2008;19(Abstracts Issue):675A.
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- Bolin P, Parker KR, Sullivan P. Optimizing tacrolimus therapy in maintenance renal allografts: follow up of a subset of patients at 24 months [abstract no: F-PO611]. Journal of the American Society of Nephrology 2007;18(Abstracts):234A.
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- Bolin P, Shihab F, Mulloy L, Gao J, Bartucci M, Holman J, et al. Optimizing tacrolimus therapy in maintenance renal allografts: 6 month results in African Americans (AA) [abstract no: F-PO1077]. Journal of the American Society of Nephrology 2006;17(Abstracts):563A.
OPTIMUM 2018 {published data only}
-
- Park S, Kim YS, Lee J, Huh W, Yang CW, Kim YL, et al. Reduced tacrolimus trough level is reflected by estimated glomerular filtration rate (eGFR) changes in stable renal transplantation recipients: results of the OPTIMUM phase 3 randomized controlled study. Annals of Transplantation 2018;23:401-11. [MEDLINE: ] - PMC - PubMed
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- Park S, Lee J, Kim Y, Kim J, Kim Y, Huh W, et al. Organ function preservation by the combination treatment of the optimum dose of calcineurin inhibitor and mycophenolate sodium in kidney recipients: OPTIMUM Study [abstract no: B946]. American Journal of Transplantation 2013;13(Suppl 5):315. [EMBASE: 71057522]
Pankewycz 2011 {published data only}
-
- Pankewycz O, Kohli R, Wallace PK, Said M, Feng L, Patel S, et al. Low dose rabbit anti-thymocyte globulin induction therapy results in prolonged selective CD4 T cell depletion irrespective of maintenance immunosuppression [abstract no: 957]. American Journal of Transplantation 2010;10(Suppl 4):316-7. [EMBASE: 70464333]
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- Pankewycz O, Kohli R, Wallace PK, Said M, Feng L, Patel SK, et al. Low dose rabbit anti-thymocyte globulin induction therapy results in prolonged selective CD4 T cell depletion irrespective of maintenance immunosuppression [abstract]. Transplantation 2010;90(Suppl 1):62. [EMBASE: 71531221] - PubMed
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- Pankewycz O, Leca N, Kohli R, Wallace PK, Said M, Feng L, et al. Low-dose rabbit antithymocyte globulin induction therapy results in prolonged selective lymphocyte depletion irrespective of maintenance immunosuppression. Transplantation Proceedings 2011;43(2):462-5. [MEDLINE: ] - PubMed
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- Pankewycz O, Leca N, Kohli R, Weber-Shrikant E, Said M, Alnimri M, et al. Conversion to low-dose tacrolimus or rapamycin 3 months after kidney transplantation: a prospective, protocol biopsy-guided study. Transplantation Proceedings 2011;43(2):519-23. [MEDLINE: ] - PubMed
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- Pankewycz O, Leca N, Said M, Feng L, Patel S, Kohli R, et al. A protocol biopsy directed randomized trial comparing tacrolimus minimization to sirolimus conversion at 3 months results in an equivalent degree of histological injury at 1 year and equivalent renal function at 2 years [abstract no: 948]. American Journal of Transplantation 2012;12(Suppl 3):304. [EMBASE: 70746901]
Paoletti 2012 {published data only}
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- Paoletti E, Marsano L, Bellino D, Cassottana P, Cannella G. Effect of everolimus on left ventricular hypertrophy of de novo kidney transplant recipients: a 1 year, randomized, controlled trial. Transplantation 2012;93(5):503-8. [MEDLINE: ] - PubMed
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- Paoletti E, Marsano L, Bellino D, Cassottana P, Rolla D, Di Maio G. Everolimus for regression of left ventricular hypertrophy of renal transplant recipients: a randomized controlled trial [abstract no: 16]. American Journal of Transplantation 2012;12(Suppl 3):31. [EMBASE: 70745963]
Pascual 2003 {published data only}
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- Pascual M, Curtis J, Delmonico FL, Farrell ML, Williams WW, Kalil R, et al. A prospective, randomized clinical trial of cyclosporine reduction in stable patients greater than 12 months after renal transplantation. Transplantation 2003;75(9):1501-5. [MEDLINE: ] - PubMed
Qazi 2017 {published data only}
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- Peddi V, Qazi Y, Shaffer D, Luan F, Shihab F, Tomlanovich S, et al. Effect of everolimus with low dose tacrolimus vs mycophenolate with standard tacrolimus regimen in African-American de novo renal transplant recipients [abstract]. Transplantation 2014;98(Suppl 1):536. [EMBASE: 71545337]
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- Qazi Y, Shaffer D, Kaplan B, Kim D, Luan F, Peddi V, et al. Efficacy and safety of everolimus with low-dose tacrolimus in de novo renal transplant recipients: 12-month randomized study [abstract no: 713]. Transplantation 2014;98(Suppl 1):80. [EMBASE: 71543789] - PubMed
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- Qazi Y, Shaffer D, Kaplan B, Kim D, Luan FL, Peddi VR, et al. Efficacy and safety of everolimus plus low-dose tacrolimus versus mycophenolate mofetil plus standard-dose tacrolimus in de novo renal transplant recipients: 12-month data. American Journal of Transplantation 2017;17(5):1358-69. [MEDLINE: ] - PubMed
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- Qazi Y, Shihab F, Mulgaonkar S, MaCague K, Patel D. Everolimus in combination with reduced dose tacrolimus is effective as a prophylaxis of acute rejection in low-to-moderate immunologic risk de novo kidney transplantation patients [abstract]. American Journal of Transplantation 2016;16(Suppl 3):217. [EMBASE: 611700341]
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- Shaffer D, Qazi Y, Kim D, Mulgaonkar S, Shihab F, Tomlanovich S, et al. Management of the wound complications in de novo renal transplant recipients: US92 12-month randomized study [abstract]. Transplantation 2014;98(Suppl 1):542-3. [EMBASE: 71545357]
REFERENCE 2006 {published data only}
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- Frimat L, Cassuto-Viguier E, Charpentier B, Noel C, Provot F, Rostaing L, et al. Impact of cyclosporine reduction with MMF: a randomized trial in chronic allograft dysfunction. The 'REFERENCE' study. American Journal of Transplantation 2006;6(11):2725-34. [MEDLINE: ] - PubMed
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- Kessler M, Frimat L, Cassuto-Viguier E, Charpentier B, Djeffal R, Noel C, et al. Impact of cyclosporine reduction with MMF in chronic allograft dysfunction: 4-year results of a multicenter randomized controlled study. The "Reference" study [abstract no: 850]. American Journal of Transplantation 2006;6(Suppl 2):353. [CENTRAL: CN-00765336] - PubMed
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- Kessler M, Frimat L, Charpentier B, Durrbach A, Noel C, Pruvot F, et al. Renal function evaluation after half dose reduction of Neoral® in combination with Cellcept® in renal transplant patients with altered renal function: preliminary 2 year safety and efficacy results of the MMF - REFERENCE study: a randomised, open, multicentre, prospective, controlled study [abstract no: 462]. American Journal of Transplantation 2004;4(Suppl 8):285. [CENTRAL: CN-00602100]
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- Kessler M, Frimat L. Renal function evalution after half dose reduction of Neoral® in combination with Cellcept® in renal transplant patients with altered renal function: preliminary 2 year safety and efficacy results of the MMF-REFERENCE study: a randomised [abstract no: 013]. Transplantation 2004;78(2 Suppl):5. [CENTRAL: CN-00509272]
Russ 2003 {published data only}
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- Russ G, Campbell S, Chadban S, Eris J, O'Connell P, Pussell B, et al. The safety and efficacy of reduced- and standard-target concentration tacrolimus plus sirolimus in renal allograft recipients: preliminary 6-month results from Australia [abstract no: SA-P0496]. Journal of the American Society of Nephrology 2002;13(September, Program & Abstracts):364A. [CENTRAL: CN-00447522]
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- Russ GR, Campbell S, Chadban S, Eris J, O'Connell P, Pussell B, et al. Reduced and standard target concentration tacrolimus with sirolimus in renal allograft recipients. Transplantation Proceedings 2003;35(3 Suppl):115-7S. [MEDLINE: ] - PubMed
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- Whelchel J, Paczek L, Bechstein WO, Russ G. A regimen of sirolimus and reduced-dose tacrolimus results in improved renal allograft function: combined analysis of the North American target, European and Australian sirolimus-tacrolimus trials [abstract]. American Journal of Transplantation 2003;3(Suppl 5):464. [CENTRAL: CN-00448351]
Salvadori 2007 {published data only}
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- Salvadori M, Scolari MP, Stefoni S, Bertoni E, Sandrini S, Rigotti P, et al. Randomized trial of sodium mycophenolate (MPS) and basiliximab in combination with reduced or standard cyclosporine (CsA) in old recipients of kidney transplant (KTx) [abstract no: O069]. Transplant International 2007;20(Suppl 2):20. [CENTRAL: CN-01657166]
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- Salvadori M, Scolari MP, Stefoni S, Bertoni E, Sandrini S, Rigotti P, et al. Randomized trial of sodium mycophenolate and basiliximab in combination with reduced or standard cyclosporine exposure in old recipients of kidney transplants from deceased donors [abstract no: 108]. Transplantation 2008;86(2 Suppl):39. [CENTRAL: CN-00679020]
Saunders 2003 {published data only}
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- Saunders RN, Bicknell GR, Nicholson ML. The impact of cyclosporine dose reduction with or without the addition of rapamycin on functional, molecular, and histological markers of chronic allograft nephropathy. Transplantation 2003;75(6):772-80. [MEDLINE: ] - PubMed
Shetty 2015 {published data only}
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- Gallon L, Leventhal J, Maluf D, Sai B, Shetty A, Traitanon O, et al. Molecular profiles of renal allograft biopsies at 12 months post renal transplant in patients exposed to low dose CNI and everolimus vs. patients exposed to full dose CNI and MMF [abstract]. American Journal of Transplantation 2017;17(Suppl 3):230. [EMBASE: 615704855]
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- Kassis Y, Park S, Shetty A, Leventhal J, Mas V, Gallon L. Long term outcomes of a steroid free, low dose tacrolimus with everolimus regimen in kidney transplant [abstract]. American Journal of Transplantation 2018;18(Suppl 4):800-1. [EMBASE: 622280693]
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- Shetty A, Leventhal J, Traitanon O, Alvarado A, Mas V, Mathew J, et al. Prospective study of a steroid free, low dose tacrolimus and everolimus combination regimen in kidney transplant [abstract]. American Journal of Transplantation 2015;15(Supp 3):n/a. [EMBASE: 71954083]
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- Shetty A, Opas T, Mathew J, Mas V, Leventhal J, Sustento-Reodica N, et al. Impact of low dose tacrolimus with everolimus regimen on renal pathology and t-regulatory cells in kidney transplant [abstract]. American Journal of Transplantation 2016;16(Suppl 3):218. [EMBASE: 611700367]
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- Shetty A, Traitanon O, Ansari M, Mathew J, Leventhal J, Mas V, et al. Prospective randomized study of a steroid free, low dose tacrolimus with everolimus regimen in kidney transplant [abstract]. American Journal of Transplantation 2016;16(Suppl 3):535-6. [EMBASE: 611700126]
SLOW & LOW 2023 {published data only}
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- Stumpf J, Budde K, Witzke O, Sommerer C, Thomas V, Schenker P, et al. Fixed low dose versus concentration-controlled initial tacrolimus dosing: Results from a prospective randomized controlled trial (SLOW&LOW STUDY) [abstract]. Nephrology dialysis transplantation 2023;38(Suppl 1):i934‐5. [DOI: 10.1093/ndt/gfad063c_4233] [EMBASE: 641942359] - DOI
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- Stumpf J, Budde K, Witzke O, Sommerer C, Vogel T, Schenker P, et al. Fixed low dose versus concentration-controlled initial tacrolimus dosing with reduced target levels in the course after kidney transplantation: results from a prospective randomized controlled non-inferiority trial (Slow & Low study). EClinicalMedicine 2024;67:102381. [PMID: ] - PMC - PubMed
SOCRATES 2014 {published data only}
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- Chadban SJ, Russ G, Kanellis J, Pilmore HL, Kim YS, Tan SY, et al. A multicentre RCT of early switch to everolimus plus steroids or everolimus plus CsA versus CsA, MPA and steroids in de novo kidney transplant recipients: 12 month analysis [abstract no: TH-OR155]. Journal of the American Society of Nephrology 2011;22(Abstract Suppl):38A.
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- Russ G, Eris J, Kanellis J, Hutchison B, Hibberd A, Pilmore H, et al. Multicentre RCT of early switch to everolimus plus steroids or everolimus plus CSA versus CSA, MPA and steroids in de novo kidney transplant recipients: 12 month analysis [abstract no: 93]. In: Transplantation Society of Australia & New Zealand (TSANZ). 30th Annual Scientific Meeting; 2012 Jun 27-29; Canberra (ACT). 2012:103. [CENTRAL: CN-01912372]
Stallone 2005 {published data only}
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- Infante B, Stallone G, Pontrelli P, Gigante M, Ranieri E, Schena FP, et al. Role of rapamycin in the induction of operational tolerance through up-regulation of ILT3 and ILT4 in kidney transplanted patients [abstract no: F-FC248]. Journal of the American Society of Nephrology 2008;19(Abstracts Issue):56A.
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- Stallone G, Infante B, Schena A, Battaglia M, Ditonno P, Loverre A, et al. Rapamycin for treatment of chronic allograft nephropathy in renal transplant patients. Journal of the American Society of Nephrology 2005;16(12):3755-62. [MEDLINE: ] - PubMed
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