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Meta-Analysis
. 2016 Aug 22;2016(8):CD005632.
doi: 10.1002/14651858.CD005632.pub3.

Steroid avoidance or withdrawal for kidney transplant recipients

Maria C Haller  1 , Ana Royuela, Evi V Nagler, Julio Pascual, Angela C Webster
Affiliations
Meta-Analysis

Steroid avoidance or withdrawal for kidney transplant recipients

Maria C Haller et al. Cochrane Database Syst Rev. .

Abstract

Background: Steroid-sparing strategies have been attempted in recent decades to avoid morbidity from long-term steroid intake among kidney transplant recipients. Previous systematic reviews of steroid withdrawal after kidney transplantation have shown a significant increase in acute rejection. There are various protocols to withdraw steroids after kidney transplantation and their possible benefits or harms are subject to systematic review. This is an update of a review first published in 2009.

Objectives: To evaluate the benefits and harms of steroid withdrawal or avoidance for kidney transplant recipients.

Search methods: We searched the Cochrane Kidney and Transplant Specialised Register to 15 February 2016 through contact with the Information Specialist using search terms relevant to this review.

Selection criteria: All randomised and quasi-randomised controlled trials (RCTs) in which steroids were avoided or withdrawn at any time point after kidney transplantation were included.

Data collection and analysis: Assessment of risk of bias and data extraction was performed by two authors independently and disagreement resolved by discussion. Statistical analyses were performed using the random-effects model and dichotomous outcomes were reported as relative risk (RR) and continuous outcomes as mean difference (MD) with 95% confidence intervals.

Main results: We included 48 studies (224 reports) that involved 7803 randomised participants. Of these, three studies were conducted in children (346 participants). The 2009 review included 30 studies (94 reports, 5949 participants). Risk of bias was assessed as low for sequence generation in 19 studies and allocation concealment in 14 studies. Incomplete outcome data were adequately addressed in 22 studies and 37 were free of selective reporting.The 48 included studies evaluated three different comparisons: steroid avoidance or withdrawal compared with steroid maintenance, and steroid avoidance compared with steroid withdrawal. For the adult studies there was no significant difference in patient mortality either in studies comparing steroid withdrawal versus steroid maintenance (10 studies, 1913 participants, death at one year post transplantation: RR 0.68, 95% CI 0.36 to 1.30) or in studies comparing steroid avoidance versus steroid maintenance (10 studies, 1462 participants, death at one year after transplantation: RR 0.96, 95% CI 0.52 to 1.80). Similarly no significant difference in graft loss was found comparing steroid withdrawal versus steroid maintenance (8 studies, 1817 participants, graft loss excluding death with functioning graft at one year after transplantation: RR 1.17, 95% CI 0.72 to 1.92) and comparing steroid avoidance versus steroid maintenance (7 studies, 1211 participants, graft loss excluding death with functioning graft at one year after transplantation: RR 1.09, 95% CI 0.64 to 1.86). The risk of acute rejection significantly increased in patients treated with steroids for less than 14 days after transplantation (7 studies, 835 participants: RR 1.58, 95% CI 1.08 to 2.30) and in patients who were withdrawn from steroids at a later time point after transplantation (10 studies, 1913 participants, RR 1.77, 95% CI 1.20 to 2.61). There was no evidence to suggest a difference in harmful events, such as infection and malignancy, in adult kidney transplant recipients. The effect of steroid withdrawal in children is unclear.

Authors' conclusions: This updated review increases the evidence that steroid avoidance and withdrawal after kidney transplantation significantly increase the risk of acute rejection. There was no evidence to suggest a difference in patient mortality or graft loss up to five year after transplantation, but long-term consequences of steroid avoidance and withdrawal remain unclear until today, because prospective long-term studies have not been conducted.

PubMed Disclaimer

Conflict of interest statement

  1. MCH: none known

  2. AR: none known

  3. EVN: none known

  4. JP: none known

  5. ACW: none known

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
3
3
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
4
4
Funnel plot of comparisons that included at least 10 studies in the meta‐analysis
1.1
1.1. Analysis
Comparison 1 Steroid withdrawal versus steroid maintenance, Outcome 1 Death and graft loss.
1.2
1.2. Analysis
Comparison 1 Steroid withdrawal versus steroid maintenance, Outcome 2 Rejection.
1.3
1.3. Analysis
Comparison 1 Steroid withdrawal versus steroid maintenance, Outcome 3 New‐onset diabetes after transplantation and cardiovascular events.
1.4
1.4. Analysis
Comparison 1 Steroid withdrawal versus steroid maintenance, Outcome 4 Infection and malignancy.
1.5
1.5. Analysis
Comparison 1 Steroid withdrawal versus steroid maintenance, Outcome 5 Kidney function.
2.1
2.1. Analysis
Comparison 2 Steroid avoidance versus steroid maintenance, Outcome 1 Death and graft loss.
2.2
2.2. Analysis
Comparison 2 Steroid avoidance versus steroid maintenance, Outcome 2 Rejection.
2.3
2.3. Analysis
Comparison 2 Steroid avoidance versus steroid maintenance, Outcome 3 New‐onset diabetes after transplantation and cardiovascular events.
2.4
2.4. Analysis
Comparison 2 Steroid avoidance versus steroid maintenance, Outcome 4 Infection and malignancy.
2.5
2.5. Analysis
Comparison 2 Steroid avoidance versus steroid maintenance, Outcome 5 Kidney function.
3.1
3.1. Analysis
Comparison 3 Steroid avoidance versus steroid withdrawal, Outcome 1 Death and graft loss.
3.2
3.2. Analysis
Comparison 3 Steroid avoidance versus steroid withdrawal, Outcome 2 Rejection.
3.3
3.3. Analysis
Comparison 3 Steroid avoidance versus steroid withdrawal, Outcome 3 New‐onset diabetes after transplantation, infection, malignancy.
3.4
3.4. Analysis
Comparison 3 Steroid avoidance versus steroid withdrawal, Outcome 4 Kidney function.
4.1
4.1. Analysis
Comparison 4 Steroid withdrawal versus maintenance in children, Outcome 1 Death and graft loss.
4.2
4.2. Analysis
Comparison 4 Steroid withdrawal versus maintenance in children, Outcome 2 Rejection, malignancy.
4.3
4.3. Analysis
Comparison 4 Steroid withdrawal versus maintenance in children, Outcome 3 Kidney function.
5.1
5.1. Analysis
Comparison 5 Publication bias, Outcome 1 Funnel plots.
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References

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    1. Kumar MS, Hahn J, Adams C, Fa K, Fyfe B, Damask A, et al. Steroid avoidance (SA) in kidney transplant recipients treated with simulect (BMAB), neoral (CSA) and cellcept (MMF)‐a randomized prospective controlled clinical trial [abstract no: 2440]. XIXth International Congress of the Transplantation Society; 2002 Aug 25‐30; Miami (FL). 2002. [CENTRAL: CN‐00416079]
    1. Kumar MS, Heifets M, Moritz MJ, Parikh MH, Saeed MI, Lingaraju R, et al. Basiliximab induction in African American recipients (AA) of cadaver kidneys (CAD) facilitates steroid avoidance, reduces acute rejection (AR) and prolongs survival [abstract no: 1627]. American Journal of Transplantation 2005;5(Suppl 11):570. [CENTRAL: CN‐00644172]
Laftavi 2005 {published data only}
    1. Laftavi M, Stefanick B, Stephan R, Kohli R, Min I, Sridhar N, et al. The significance of protocol biopsy in immunominimization protocol: a prospective study of steroid withdrawal [abstract no: O229]. Transplantation 2004;78(2 Suppl):89. [CENTRAL: CN‐00509305]
    1. Laftavi MR, Leca N, Dagher F, Kilmer L, Stephanick B, Kohli R, et al. Steroid withdrawal is associated with more chronic allograft nephropathy (CAN) following kidney transplantation [abstract no: 518]. American Journal of Transplantation 2005;5(Suppl 11):288.
    1. Laftavi MR, Stephan R, Stefanick B, Kohli R, Dagher F, Applegate M, et al. Randomized prospective trial of early steroid withdrawal compared with low‐dose steroids in renal transplant recipients using serial protocol biopsies to assess efficacy and safety. Surgery 2005;137(3):364‐71. [MEDLINE: ] - PubMed
    1. Pankewycz OG, Stephan R, Stefanick B, Dagher F, Applegate M, Kohli R, et al. The clinical benefits of early steroid withdrawal (7 days) and utility of protocol biopsies at 1, 6 and 12 months in guiding steroid‐free immunosuppressive therapy after renal transplantation [abstract no: 1534]. American Journal of Transplantation 2004;4(Suppl 8):579. [CENTRAL: CN‐00509401]
    1. Pankewyez O, Stephan R, Stefanick B, Rubino A, Kohli R, Min I, et al. Induction immunosuppression for renal transplantation using thymoglobulin, FK506 and mycophenolate mofetil allows for safe steroid withdrawal and eliminates the need for early protocol biopsies [abstract no: 1271]. American Journal of Transplantation 2003;3(Suppl 5):478. [CENTRAL: CN‐00447092]
Lebranchu 1999 {published data only}
    1. Hene RJ, M55002 Study Group. A randomized, double‐blind, multi‐center trial comparing two corticosteroid regimens in combination with mycophenolate mofetil (MMF) and cyslosporine (CYA) in renal transplant recipients [abstract no: 420]. Transplantation 1998;65(12):S107. [CENTRAL: CN‐00763818]
    1. Lebranchu Y. Comparison of two corticosteroid regimens in combination with CellCept and cyclosporine A for prevention of acute allograft rejection: 12 month results of a double‐blind, randomized, multi‐center study. M 55002 Study Group. Transplantation Proceedings 1999;31(1‐2):249‐50. [MEDLINE: ] - PubMed
    1. Lebranchu Y, Aubert P, Bayle F, Bedrossian J, Berthoux F, Bourbigot B, et al. Could steroids be withdrawn in renal transplant patients sequentially treated with ATG, cyclosporine, and cellcept? One‐year results of a double‐blind, randomized, multicenter study comparing normal dose versus low‐dose and withdrawal of steroids. M 55002 French Study Group. Transplantation Proceedings 2000;32(2):396‐7. [MEDLINE: ] - PubMed
    1. Lebranchu Y, M55002 Study Group. A comparison of two corticosteroid regimens in kidney transplanted patients treated with ATG/OKT3 induction, mycophenolate mofetil (MMF) and cyclosporine A (CyA) for prevention of acute allograft rejection. 12 months results of a double‐blind, randomized, multi‐center study [abstract no: 932]. Transplantation 1999;67(7):S239. [CENTRAL: CN‐00763351] - PubMed
    1. Nowacka‐Cieciura E, Durlik M, Cieciura T, Kukula K, Lewandowska D, Baczkowska T, et al. Elevated serum immunoglobulins after steroid withdrawal in renal allograft recipients. Transplantation Proceedings 2002;34(2):564‐6. [MEDLINE: ] - PubMed
Maiorca 1988 {published data only}
    1. Cristinelli L, Brunori G, Manganoni AM, Manganoni A, Setti G, Maiorca R. Controlled study of steroid withdrawal after 6 months in renal transplant patients treated with ciclosporin. Contributions to Nephrology 1986;51:91‐5. [MEDLINE: ] - PubMed
    1. Cristinelli L, Brunori G, Setti G, Manganoni A, Manganoni AM, Scolari F, et al. Withdrawal of methylprednisolone at the sixth month in renal transplant recipients treated with cyclosporine. Transplantation Proceedings 1987;19(1 Pt 3):2021‐3. [MEDLINE: ] - PubMed
    1. Cristinelli L, Brunori G, Setti G, Scolari F, Scaini P, Manganoni S, et al. Controlled randomised trial of methylprednisolone withdrawal at the sixth month in renal transplant recipients treated with cyclosporin [abstract]. Nephrology Dialysis Transplantation 1986;1(2):139. [CENTRAL: CN‐00260301]
    1. Maiorca R, Cristinelli L, Brunori G, Setti G, Salerni B, Nobili U, et al. Prospective controlled trial of steroid withdrawal after six months in renal transplant patients treated with cyclosporine. Transplantation Proceedings 1988;20(3 Suppl 3):121‐5. [MEDLINE: ] - PubMed
Matl 2000 {published data only}
    1. Matl I, Lacha J, Lodererova A, Simova M, Teplan V, Lanska V, et al. Withdrawal of prednisone from a triple combination of immunosuppressive agents after kidney transplantation [Vysazení prednisonu z trojkombinace imunosupresiv u nemocných po transplantaci ledviny]. Casopis Lekaru Ceskych 2000;139(4):115‐9. [MEDLINE: ] - PubMed
    1. Matl I, Lacha J, Lodererova A, Simova M, Teplan V, Lanska V, et al. Withdrawal of steroids from triple‐drug therapy in kidney transplant patients. Nephrology Dialysis Transplantation 2000;15(7):1041‐5. [MEDLINE: ] - PubMed
    1. Matl I, Lacha J, Lodererova A, Simova M, Vitko S. Withdrawal of steroids from triple drug therapy in renal transplant patients [abstract]. 35th Congress. European Renal Association. European Dialysis and Transplantation Association; 1998 Jun 6‐9; Rimini, Italy. 1998:351. [CENTRAL: CN‐00485004] - PubMed
Mericq 2013 {published data only}
    1. Mericq V, Salas P, Pinto V, Cano F, Reyes L, Brown K, et al. Steroid withdrawal in pediatric kidney transplant allows better growth, lipids and body composition: a randomized controlled trial. Hormone Research in Pædiatrics 2013;79(2):88‐96. [MEDLINE: ] - PubMed
Montagnino 2005 {published data only}
    1. Montagnino G, Sandrini S, Casciani C, Schena FP, Carmellini M, Civati G, et al. A randomized trial of steroid avoidance in renal transplant patients treated with everolimus and cyclosporine. Transplantation Proceedings 2005;37(2):788‐90. [MEDLINE: ] - PubMed
    1. Montagnino G, Sandrini S, Iorio B, Schena FP, Carmellini M, Rigotti P, et al. A randomized exploratory trial of steroid avoidance in renal transplant patients treated with everolimus and low‐dose cyclosporine. Nephrology Dialysis Transplantation 2008;23(2):707‐14. [MEDLINE: ] - PubMed
    1. Ponticelli C, Sandrini S, Casciani C, Schena FP, STAR Group. A randomized trial of steroid avoidance in renal transplant patients treated with everolimus and cyclosporine. [abstract no: O432]. Transplantation 2004;78(2 Suppl):170. [CENTRAL: CN‐00509422] - PubMed
Nagib 2015 {published data only}
    1. Nagib AM, Abbas MH, Abu‐Elmagd MM, Denewar AA, Neamatalla AH, Refaie AF, et al. Long‐term study of steroid avoidance in renal transplant patients: a single‐center experience. Transplant Proceedings 2015;47(4):1099‐104. [MEDLINE: ] - PubMed
    1. Nagib AM, Neamatalla AH, Bakr MA, Refaie AF, Abo‐Elmagd MM, Wafa IW. Long term study of steroid avoidance in renal transplant patients: A single center experience [abstract]. Experimental & Clinical Transplantation 2014;12:100. [EMBASE: 71976229] - PubMed
Nematalla 2007 {published data only}
    1. Gheith OA, Nematalla AH, Bakr MA, Refaie A, Shokeir AA, Ghoneim MA. Cost‐benefit of steroid avoidance in renal transplant patients: a prospective randomized study. Scandinavian Journal of Urology & Nephrology 2010;44(3):175‐82. [MEDLINE: ] - PubMed
    1. Gheith OA, Nematalla AH, Bakr MA, Refaie A, Shokeir AA, Ghoneim MA. Steroid avoidance reduce the cost of morbidities after live‐donor renal allotransplants: a prospective, randomized, controlled study. Experimental & Clinical Transplantation: Official Journal of the Middle East Society for Organ Transplantation 2011;9(2):121‐7. [MEDLINE: ] - PubMed
    1. Neamatalla A, Bakr A, Agroudy A, Shehawy E, Shokier A, Ghoneim M. Improving quality of life after steroid avoidance immunosuppression regimen in live donor renal allotransplant recipients ‐ a prospective randomized controlled study single center experience (two year follow up) [abstract no: FP222]. Nephrology Dialysis Transplantation 2007;22(Suppl 6):vi93. - PubMed
    1. Neamatalla AH, Bakr MA, Agroudy AE, Shehawy EL, Shokier AA. Improving quality of life after steroid avoidance immunosuppression regimen in live donor renal allotransplant recipients ‐ a prospective randomized controlled study single center experience (two year follow up) [abstract no: P163]. Transplant International 2007;20(Suppl 2):134. [CENTRAL: CN‐00653762] - PubMed
    1. Nematalla AH, Bakr MA, Agroudy A, Shehawy E, Abdel Rahman ME. Steroid free immunosuppression regimen in live donor renal allotransplant recipients ‐ a prospective randomized study (single center experience) [abstract no: PO‐466]. Transplant International 2005;18(Suppl 1):157.
Nott 1985 {published data only}
    1. Griffin PJ, Costa CA, Salaman JR. A controlled trial of steroids in cyclosporine‐treated renal transplant recipients. Transplantation 1987;43(4):505‐8. [MEDLINE: ] - PubMed
    1. Griffin PJ, Gomes da Costa CA, Salaman JR. Renal transplantation without steroids: a controlled clinical trial. Transplantation Proceedings 1986;18(4):797‐8. [EMBASE: 1986223826]
    1. Nott D, Griffin PJ, Salaman JR. Low‐dose steroids do not augment cyclosporine immunosuppression but do diminish cyclosporine nephrotoxicity. Transplantation Proceedings 1985;17(1 II):1289‐90. [EMBASE: 1985078719]
    1. Salaman JR, Gomes Da Costa CA, Griffin PJ. Renal transplantation without steroids. Journal of Pediatrics 1987;111(6 Pt 2):1026‐8. [MEDLINE: ] - PubMed
Park 1994 {published data only}
    1. Kim HC, Chang KJ, Kwon JK, Park SB, Cho WH, Park CH. Long‐term results of cyclosporine monotherapy in renal transplantation. Transplantation Proceedings 1998;30(7):3539‐40. [MEDLINE: ] - PubMed
    1. Park K, Kim ST, Lee SR, Koh YB, Kim HC. A 1‐year prospective randomized study in Korean living donor kidney transplant recipients: comparing cyclosporine monotherapy and cyclosporine/prednisolone during the maintenance phase of immunosuppression. Transplantation Proceedings 1994;26(4):1985‐6. [MEDLINE: ] - PubMed
Pelletier 2006 {published data only}
    1. Akin B, Ferguson RM, Pelletier RP. Five year follow‐up after steroid withdrawal demonstrates no evidence of worsening renal function [abstract]. American Journal of Transplantation 2004;4(Suppl 8):298. [CENTRAL: CN‐00509047]
    1. Ing SW, Sinnott LT, Davies EA, Pelletier RP. Bone mineral density changes in a prospective, randomized trial of steroid withdrawal in kidney transplant recipients [abstract no: 621]. American Journal of Transplantation 2007;7(Suppl 2):310. [CENTRAL: CN‐00764017]
    1. Ing SW, Sinnott LT, Donepudi S, Davies EA, Pelletier RP, Lane NE. Change in bone mineral density at one year following glucocorticoid withdrawal in kidney transplant recipients. Clinical Transplantation 2011;25(2):E113‐23. [MEDLINE: ] - PMC - PubMed
    1. Pelletier RP, Akin B, Ferguson RM. Prospective, randomized trial of steroid withdrawal in kidney recipients treated with mycophenolate mofetil and cyclosporine. Clinical Transplantation 2006;20(1):10‐8. [MEDLINE: ] - PubMed
    1. Pelletier RP, Davies EA, Elkhammas EA, Bumgardner GL, Henry ML, Ferguson RM. Randomized, prospective trial of prednisone withdrawal in stable renal transplant recipients [abstract]. Transplantation 2000; Vol. 69, issue 8 Suppl:S260. [CENTRAL: CN‐00447152]
Pisani 2001 {published data only}
    1. Coppelli A, Buonomo O, Iaria G, Pisani F, Pollicita S, Rizzello A. Preliminary results of a prospective randomized study of basiliximab and steroid withdrawal in kidney transplantation [abstract no: 1617]. 2001 A Transplant Odyssey; 2001 Aug 20‐23; Istanbul, Turkey. 2001. [CENTRAL: CN‐00400600]
    1. Pisani F, Buonomo O, Iaria G, Tisone G, Mazzarella V, Pollicita S, et al. Preliminary results of a prospective randomized study of basiliximab in kidney transplantation. Transplantation Proceedings 2001;33(1‐2):2032‐3. [MEDLINE: ] - PubMed
Ponticelli 1997 {published data only}
    1. Aroldi A, Tarantino A, Montagnino G, Cesana B, Cocucci C, Ponticelli C. Effects of three immunosuppressive regimens on vertebral bone density in renal transplant recipients: a prospective study. Transplantation 1997;63(3):380‐6. [MEDLINE: ] - PubMed
    1. Montagnino G, Tarantino A, Maccario M, Elli A, Cesana B, Ponticelli C. Long‐term results with cyclosporine monotherapy in renal transplant patients: a multivariate analysis of risk factors. American Journal of Kidney Diseases 2000;35(6):1135‐43. [MEDLINE: ] - PubMed
    1. Montagnino G, Tarantino A, Segoloni GP, Cambi V, Rizzo G, Altieri P, et al. Long‐term results of a randomized study comparing three immunosuppressive schedules with cyclosporine in cadaveric kidney transplantation. Journal of the American Society of Nephrology 2001;12(10):2163‐9. [MEDLINE: ] - PubMed
    1. Ponticelli C. Steroid withdrawal in organ transplant recipients [abstract no: 0351]. XVIII International Congress of the Transplantation Society; 2000 Aug 27‐Sept 1; Rome, Italy. 2000. [CENTRAL: CN‐00583616]
    1. Ponticelli C, Aroldi A. Osteoporosis after organ transplantation. Lancet 2001;357(9268):1623. [MEDLINE: ] - PubMed
Ratcliffe 1993 {published data only}
    1. Dudley CR, Ratcliffe PJ, et al. Effect of steroid withdrawal on graft function in renal transplant recipients [abstract]. Nephrology Dialysis Transplantation 1994;9(11):1672. [CENTRAL: CN‐00261076]
    1. Ratcliffe PJ, Dudley CR, Higgins RM, Firth JD, Smith B, Morris PJ. Randomised controlled trial of steroid withdrawal in renal transplant recipients receiving triple immunosuppression. Lancet 1996;348(9028):643‐8. [MEDLINE: ] - PubMed
    1. Ratcliffe PJ, Firth JD, Higgins RM, Smith B, Gray DW, Morris PJ. Randomized controlled trial of complete steroid withdrawal in renal transplant patients receiving triple immunosuppression. Transplantation Proceedings 1993;25(1 Pt 1):590. [MEDLINE: ] - PubMed
Sandrini 2009 {published data only}
    1. Sandrini S, Setti G, Bossini N, Chiappini R, Valerio F, Mazzola G, et al. Early (fifth day) vs. late (sixth month) steroid withdrawal in renal transplant recipients treated with Neoral plus Rapamune: four‐yr results of a randomized monocenter study. Clinical Transplantation 2010;24(5):669‐77. [MEDLINE: ] - PubMed
    1. Sandrini S, Setti G, Bossini N, Maffei C, Iovinella L, Tognazzi N, et al. Steroid withdrawal five days after renal transplantation allows for the prevention of wound‐healing complications associated with sirolimus therapy. Clinical Transplantation 2009;23(1):16‐22. [MEDLINE: ] - PubMed
Schulak 1989 {published data only}
    1. Hricik DE, Mayes JT, Schulak JA. Independent effects of cyclosporine and prednisone on posttransplant hypercholesterolemia. American Journal of Kidney Diseases 1991;18(3):353‐8. [MEDLINE: ] - PubMed
    1. Hricik DE, Moritz C, Mayes JT, Schulak JA. Association of the absence of steroid therapy with increased cyclosporine blood levels in renal transplant recipients. Transplantation 1990;49(1):221‐3. [MEDLINE: ] - PubMed
    1. Hricik DE, Whalen CC, Lautman J, Bartucci MR, Moir EJ, Mayes JT, et al. Withdrawal of steroids after renal transplantation‐‐clinical predictors of outcome. Transplantation 1992;53(1):41‐5. [MEDLINE: ] - PubMed
    1. Schulak JA, Mayes JT, Moritz CE, Hricik DE. A prospective randomized trial of prednisone versus no prednisone maintenance therapy in cyclosporine‐treated and azathioprine‐treated renal transplant patients. Transplantation 1990;49(2):327‐32. [MEDLINE: ] - PubMed
    1. Schulak JA, Moritz CE, Hricik DE. Renal transplantation without prednisolone: effects of bone marrow tolerance azathioprine. Transplantation Proceedings 1989;21(1 Pt 2):1709‐11. [MEDLINE: ] - PubMed
Smak Gregoor 1999 {published data only}
    1. Roodnat J, Hilbrands LB, Hene RJ, Sevaux RG, Gregoor PJ, Gestel JA, et al. 15 year follow‐up of a multicentre, randomised, calcineurin inhibitor (CNI) withdrawal study in kidney transplantation [abstract no: BO156]. Transplant International 2013;26(Suppl 2):83‐4. [EMBASE: 71359271]
    1. Roodnat JI, Hilbrands LB, Hene RJ, Sevaux RG, Smak Gregoor PJ, Kal‐van Gestel JA, et al. 15‐year follow‐up of a multicenter, randomized, calcineurin inhibitor withdrawal study in kidney transplantation. Transplantation 2014;98(1):47‐53. [MEDLINE: ] - PubMed
    1. Smak Gregoor PJ, Sevaux RG, Ligtenberg G, et al. A prospective randomised study of withdrawal of cyclosporine or prednisone in renal transplant recipients treated with mycophenolate mofetil, cyclosporine, and prednisone: 18 months follow‐up data [abstract]. American Journal of Transplantation 2001;1(Suppl 1):246. [CENTRAL: CN‐00763745]
    1. Smak Gregoor PJ, Sevaux RG, Hene RJ, Hesse CJ, Hilbrands LB, Vos P, et al. Effect of cyclosporine on mycophenolic acid trough levels in kidney transplant recipients. Transplantation 1999;68(10):1603‐6. [MEDLINE: ] - PubMed
    1. Smak Gregoor PJ, Sevaux RG, Ligtenberg G, Hoitsma AJ, Hene RJ, Weimar W, et al. Withdrawal of cyclosporine or prednisone six months after kidney transplantation in patients on triple drug therapy: a randomized, prospective, multicenter study. Journal of the American Society of Nephrology 2002;13(5):1365‐73. [MEDLINE: ] - PubMed
Sola 2002 {published data only}
    1. Sola E, Alférez MJ, Cabello M, Burgos D, González MM. Low‐dose and rapid steroid withdrawal in renal transplant patients treated with tacrolimus and mycophenolate mofetil. Transplantation Proceedings 2002;34(5):1689‐90. [MEDLINE: ] - PubMed
Stiller 1983 {published data only}
    1. Canadian Transplant Study Group. The requirements for maintenance steroids in cyclosporine‐treated renal transplant recipients [abstract]. Kidney International 1984;25(6):998.
    1. MacDonald AS, Daloze P, Dandavino R, Jindal S, Bear L, Dossetor JB, et al. A randomized study of cyclosporine with and without prednisone in renal allograft recipients. Canadian Transplant Group. Transplantation Proceedings 1987;19(1 Pt 3):1865‐6. [MEDLINE: ] - PubMed
    1. Stiller C. The requirements for maintenance steroids in cyclosporine‐treated renal transplant recipients. Transplantation Proceedings 1983;15(4 Suppl 1‐2):2490‐4. [EMBASE: 1984089082]
THOMAS Study 2002 {published data only}
    1. Boots JM, Ham EC, Christiaans MH, Hooff JP. Risk of adrenal insufficiency with steroid maintenance therapy in renal transplantation. Transplantation Proceedings 2002;34(5):1696‐7. [MEDLINE: ] - PubMed
    1. Budde K, Salmela K, Pascual J, Rigotti P, THOMAS Follow‐up Study Group. Steroid‐withdrawal in tacrolimus‐treated renal transplant recipients: results of a 3‐year follow‐up study [abstract]. 3rd International Congress on Immunosuppression; 2004 Dec 8‐11; San Diego (CA). 2004. [CENTRAL: CN‐00550470]
    1. Jindal RM, Salmela K, Vanrentergheim Y, Hooff JP, Squifflet JP. Reduction of high cholesterol levels by early withdrawal of steroids from a tacrolimus‐based triple regimen [abstract no: 206]. American Journal of Transplantation 2002;2(Suppl 3):190. [CENTRAL: CN‐00520347]
    1. Pascual J, Hooff JP, Salmela K, Lang P, Rigotti P, Budde K. Three‐year observational follow‐up of a multicenter, randomized trial on tacrolimus‐based therapy with withdrawal of steroids or mycophenolate mofetil after renal transplant. Transplantation 2006;82(1):55‐61. [MEDLINE: ] - PubMed
    1. Pascual J, Vanrenterghem Y, Hooff JP, Squifflet JP, Salmela K, Rigotti P. Safe withdrawal of MMF or steroids following 3‐months of tacrolimus triple therapy: results of a large, prospective, multicentre study [abstract]. XIXth International Congress of the Transplantation Society; 2002 Aug 25‐30; Miami (FL). 2002. [CENTRAL: CN‐00416426]
Vincenti 2003a {published data only}
    1. Painter PL, Topp KS, Krasnoff JB, Adey D, Strasner A, Tomlanovich S, et al. Health‐related fitness and quality of life following steroid withdrawal in renal transplant recipients. Kidney International 2003;63(6):2309‐16. [MEDLINE: ] - PubMed
    1. Topp KS, Painter PL, Walcott S, Krasnoff JB, Adey D, Sakkas GK, et al. Alterations in skeletal muscle structure are minimized with steroid withdrawal after renal transplantation. Transplantation 2003;76(4):667‐73. [MEDLINE: ] - PubMed
    1. Vincenti F, Monaco A, Grinyo J, Kinkhabwala M, Neylan J, Roza A, et al. A multicenter randomized trial of rapid steroid withdrawal vs standard steroid treatment in patients treated with Simulect, Neoral and Cellcept for the prevention of acute rejection in renal transplantation [abstract no: 583]. Transplantation 1999;67(7):S152. [CENTRAL: CN‐00403005]
    1. Vincenti F, Monaco A, Grinyo J, Kinkhabwala M, Neylan J, Roza A, et al. Rapid steroid withdrawal versus standard steroid therapy in patients treated with basiliximab, cyclosporine, and mycophenolate mofetil for the prevention of acute rejection in renal transplantation. Transplantation Proceedings 2001;33(1‐2):1011‐2. [MEDLINE: ] - PubMed
    1. Vincenti F, Monaco A, Grinyo J, Kinkhabwala M, Roza A. Multicenter randomized prospective trial of steroid withdrawal in renal transplant recipients receiving basiliximab, cyclosporine microemulsion and mycophenolate mofetil. American Journal of Transplantation 2003;3(3):306‐11. [MEDLINE: ] - PubMed
Woodle 2005 {published data only}
    1. Alloway R, Woodle ES, Gaber AO, Pirsch J, Shihab F, Veldhuisen P, et al. Multivariate analysis of risk factors for acute rejection with early (7 day) corticosteroid withdrawal: results from a randomized, double blind, placebo‐controlled trial [abstract no: 567]. American Journal of Transplantation 2006;6(Suppl 2):257.
    1. Gaber AO, Moore LW, Alloway RR, Woodle ES, Pirsch J, Shihab F, et al. Acute rejection characteristics from a prospective, randomized, double‐blind, placebo‐controlled multicenter trial of early corticosteroid withdrawal. Transplantation 2013;95(4):573‐9. [MEDLINE: ] - PubMed
    1. Gaber AO, Moore LW, Pirsch J, Shihab F, Woodle ES, Astellas Steroid Withdrawal Study Group. Characteristics of rejection in renal allografts following early corticosteroid withdrawal in a randomized controlled clinical trial: results of 3 year followup [abstract no: 330]. American Journal of Transplantation 2006;6(Suppl 2):178. [CENTRAL: CN‐00764094]
    1. Lin S, Henning AK, Akhlaghi F, Reisfield R, Vergara‐Silva A, First MR. Interleukin‐2 receptor antagonist therapy leads to increased tacrolimus levels after kidney transplantation. Therapeutic Drug Monitoring 2015;37(2):206‐13. [MEDLINE: ] - PubMed
    1. Pirsch J, Woodle ES, Shihab F, Gaber AO, Veldhuisen P, Gao J, et al. Effect of steroid withdrawal on new onset diabetes after transplant: results of a randomized double‐blind placebo controlled trial [abstract no: 856]. American Journal of Transplantation 2006;6(Suppl 2):355.
Zhu 2008a {published data only}
    1. Zhu QG, Zhao YK, Liu W, Luo H, Qiu Y, Gao ZZ. Two‐year observation of a randomized trial on tacrolimus‐based therapy with withdrawal of steroids or mycophenolate mofetil after renal transplantation. Chinese Medical Sciences Journal 2008;23(4):244‐8. [MEDLINE: ] - PubMed

References to studies excluded from this review

Alexander 2006 {published data only}
    1. Alexander JW, Goodman HR, Cardi M, Austin J, Goel S, Safdar S, et al. Simultaneous corticosteroid avoidance and calcineurin inhibitor minimization in renal transplantation. Transplant International 2006;19(4):295‐302. [MEDLINE: ] - PubMed
Anil Kumar 2005 {published data only}
    1. Anil Kumar MS, Fyfe B, Sierka D, Heifets M, Saeed MI, Parikh MH. Comparison of efficacy and safety of sirolimus (SLR) and mycophenolate mofetil (MMF) as adjunct to calcineurin inhibitor (CNIi) based steroid free immunosuppression in kidney transplantation [abstract]. American Journal of Transplantation 2004;4(Suppl 8):578. [CENTRAL: CN‐00509056]
    1. Anil Kumar MS, Heifets M, Fyfe B, Saaed MI, Moritz MJ, Parikh MH, et al. Comparison of steroid avoidance in tacrolimus/mycophenolate mofetil and tacrolimus/sirolimus combination in kidney transplantation monitored by surveillance biopsy. Transplantation 2005;80(6):807‐14. [MEDLINE: ] - PubMed
    1. Anil Kumar MS, Heifets M, Fyfe B, Sierka D, Saeed MI, Parekh M, et al. A prospective randomized study to compare the efficacy and safety of sirolimus (SLR) and mycophenolate mofetil (MMF) monitored by protocol biopsies in tacrolimus (TAC) based steroid free immunosuppression [abstract]. American Journal of Transplantation 2004;4(Suppl 8):216. [CENTRAL: CN‐00509296]
    1. Kumar A, Lee D, Xiao SG, Moritz MJ, Fyfe B, Heifets M, et al. Comparison of tacrolimus (FK506) and sirolimus (SRL) combination with FK506 and mycophenolate mofetil (MMF) in kidney transplant recipients with steroid avoidance [abstract]. American Journal of Transplantation 2003;3(Suppl 5):350. [CENTRAL: CN‐00446223]
Axelrod 2005 {published data only}
    1. Axelrod D, Leventhal JR, Gallon LG, Parker MA, Kaufman DB. Reduction of CMV disease with steroid‐free immunosuppression in simultaneous pancreas‐kidney transplant recipients. American Journal of Transplantation 2005;5(6):1423‐9. [MEDLINE: ] - PubMed
Berney 2004 {published data only}
    1. Berney T, Bucher P, Mathe Z, Andres A, Bosco D, Mage R, et al. Islet of langerhans allogeneic transplantation at the University of Geneva in the steroid free era in islet after kidney and simultaneous islet‐kidney transplantations. Transplantation Proceedings 2004;36(4):1121‐2. [MEDLINE: ] - PubMed
Birkeland 1998b {published data only}
    1. Birkeland SA, Larsen KE, Rohr N. Pediatric renal transplantation without steroids. Pediatric Nephrology 1998;12(2):87‐92. [MEDLINE: ] - PubMed
Birkeland 2002 {published data only}
    1. Birkeland SA, Beck‐Nielsen H, Rohr N, Bertuzzi F, Secchi A, Shapiro J, et al. Steroid‐free immunosuppression in kidney‐islet transplantation: a long‐term follow‐up. Transplantation 2002;73(9):1527. [MEDLINE: ] - PubMed
Budde 2001 {published data only}
    1. Budde K, Diekmann F, Fritsche L, Geissler S, Hallebach G, Neumayer H. Steroid withdrawal in long‐term cyclosporine treated patients using mycophenolate mofetil: a prospective randomized pilot study [abstract no: 1233]. A Transplant Odyssey; 2001 Aug 20‐23; Istanbul, Turkey. 2001. [CENTRAL: CN‐00644340] - PubMed
    1. Budde K, Fritsche L, Geissler S, Hallebach G, Diekmann F, Mai I, et al. Steroid withdrawal in long‐term cyclosporine A treated patients using mycophenolate mofetil: a prospective randomized pilot study. Transplantation Proceedings 2001;33(7‐8):3250‐2. [MEDLINE: ] - PubMed
    1. Budde K, Geissler S, Hallebach G, Fritsche L, Waiser J, Neumayer H. Prospective randomized trial of steroid withdrawal in mycophenolate mofetil (MMF) and cyclosporine (CYA) treated patients (PTS) [abstract]. Journal of the American Society of Nephrology 1998;9(Program & Abstracts):668A. [CENTRAL: CN‐00444574]
    1. Budde K, Geissler S, Hallebach G, Waiser J, Fritsche L, Bohler T, et al. Prospective randomized pilot study of steroid withdrawal with mycophenolate mofetil in long‐term cyclosporine‐treated patients: 4‐year follow‐up. Transplantation Proceedings 2002;34(5):1703‐5. [MEDLINE: ] - PubMed
CAMPASIA Study 2005 {published data only}
    1. 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
    1. Vathsala A, CAMPASIA Study Group. Safety and efficacy of campath‐1h (mabcampath®) with low dose cyclosporine monotherapy in patients receiving kidney transplants ‐ 6 month analysis of the pilot randomised controlled [abstract]. Transplantation 2004;78(2 Suppl):56. [CENTRAL: CN‐00509538]
    1. Vathsala A, Campasia Study Group. One year results of a pilot randomised controlled trial of the effectiveness of alemtuzumab as an induction agent for prevention of graft rejection and preservation of renal function in patients receiving kidney transplants [abstract no: T‐PO50029]. Nephrology 2005;10(Suppl):A215. [CENTRAL: CN‐00583367]
    1. Vathsala A, Ona ET, Tan S, Suresh S, Chan Y, Lou H, et al. CAMPASIA: 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]. American Journal of Transplantation 2004;4(Suppl 8):406. [CENTRAL: CN‐00509539]
    1. 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]
CARMEN Study 2005 {published data only}
    1. Budde K, Neumayer HH, Rostaing L, Catarovich D, Mourad G, Rigotti P, et al. Steroid‐free immunosuppression with daclizumab, tacrolimus and MMF is efficacious and improves cholesterol, glucose and bone mineral density ‐ the CARMEN study [abstract]. Transplantation 2004;78(2 Suppl):168. [CENTRAL: CN‐00509111]
    1. Cantarovich D, Rostaing L, Mourad G, Neumayer HH, Rigotti P, Tacrolimus Steroid Withdrawal Study Group. The combination of Daclizumab, Tacrolimus, and MMF is an effective and safe steroid‐free immunosuppressive regimen after renal transplantation. Results of a large multicentre trial [abstract]. Nephrology Dialysis Transplantation 2003;18(Suppl 4):788. [CENTRAL: CN‐00444672]
    1. Kramer BK, Kruger B, Mack M, Obed A, Banas B, Paczek L, et al. Steroid withdrawal or steroid avoidance in renal transplant recipients: focus on tacrolimus‐based immunosuppressive regimens. Transplantation Proceedings 2005;37(4):1789‐91. [MEDLINE: ] - PubMed
    1. Mourad G, Rostaing L, Cantarovich D, Neumayer H, Rigotti P, Tacrolimus Steroid Withdrawal Study Group. Immunosuppression without steroids: daclizumab/tacrolimus/MMF vs. tacrolimus/MMF/steroids in renal transplantation [abstract no: 12]. 11th Congress of the European Society for Transplantation (ESOT); 2003 Sept 20‐24; Venice, Italy. 2003. [CENTRAL: CN‐00653705]
    1. Pascual J, Rigotti P, Vialtel P, Sanchez‐Fructuoso A, Escuin F, Bone Mineral Density Study Group. Immunosuppression without steroids: a daclizumab, tacrolimus and MMF regimen prevents loss of bone mass following renal transplantation [abstract no: 369]. 11th Congress of the European Society for Transplantation (ESOT); 2003 Sept 20‐24; Venice, Italy. 2003. [CENTRAL: CN‐00653764]
Citterio 2002 {published data only}
    1. Citterio F, Baldan N, Tondolo E, Marchini F, Castagneto M, Rigotti P. Medium term results of steroid withdrawal in tacrolimus treated renal transplant recipients [abstract]. 3rd International Congress on Immunosuppression; 2004 Dec 8‐11; San Diego (CA). 2004. [CENTRAL: CN‐00550659]
    1. Citterio F, Baldan N, Tondolo V, Marchini F, Romagnoli J, Furian L, et al. Five years prospective study of steroid withdrawal in renal transplant recipients [abstract no: 340]. American Journal of Transplantation 2005;5(Suppl 11):242. [CENTRAL: CN‐00644339]
    1. Citterio F, Rigotti P, Scata MC, Baldan N, Marchini F, Castagneto M. Steroid withdrawal in renal transplant patients immunosuppressed with tacrolimus [abstract no: 135]. American Journal of Transplantation 2002;2(Suppl 3):172. [CENTRAL: CN‐00415437] - PubMed
    1. Citterio F, Rigotti P, Scata MC, Romagnoli J, Baldan N, Marchini F, et al. Steroid withdrawal from tacrolimus‐based therapy in renal transplant patients. Transplantation Proceedings 2002;34(5):1707‐8. [MEDLINE: ] - PubMed
CORRETA Study 2008 {published data only}
    1. Garcia VD, Carvalho DB, Goncalves RT, Cavalcanti RL, Campos HH, Abbud‐Filho M, et al. CORRETA trial (corticosteroid reduction with tacrolimus): prospective Brazilian multicenter, randomized trial of early corticosteroid reduction vs regular corticosteroid dosage maintenance on a tacrolimus (Prograf®) and mycophenolate mofetil (Cellcept®) immunosuppression regimen in kidney transplant recipients ‐ interim analysis [abstract no: P146]. Transplant International 2007;20(Suppl 2):130‐1. [CENTRAL: CN‐00724889] - PubMed
    1. Garcia VD, Carvalho DB, Goncalves RT, Cavalcanti RL, Campos HH, Abbud‐Filho M, et al. Corticosteroid reduction with tacrolimus (CORRETA) TRIAL: a prospective Brazilian multicenter, randomized trial of early corticosteroid reduction versus regular corticosteroid dosage maintenance on a tacrolimus (Prograf) and mycophenolate mofetil (Cellcept) immunosuppression regimen in kidney transplant recipients: interim analysis. Transplantation Proceedings 2008;40(3):689‐92. [MEDLINE: ] - PubMed
    1. Garcia VD, Carvalho DB, Goncalves RT, Cavalcanti RL, Campos HH, Abbud‐Filho M, et al. Randomized trial of early corticosteroid reduction vs. regular‐dose corticosteroid maintenance in combination with tacrolimus and mycophenolate mofetil in living donor kidney transplant recipients: the Brazilian CORRETA trial. Clinical Transplantation 2010;24(4):E109‐15. [MEDLINE: ] - PubMed
Curtis 1982 {published data only}
    1. Curtis JJ, Galla JH, Woodford SY, Lucas BA, Luke RG. Effect of alternate‐day prednisone on plasma lipids in renal transplant recipients. Kidney International 1982;22(1):42‐7. [MEDLINE: ] - PubMed
Daniel 1985 {published data only}
    1. Daniel V, Opelz G, Dreikorn K. Lymphocyte subpopulations in kidney transplant patients with different types of immunosuppression. Transplantation Proceedings 1985;17(6):2254‐7. [EMBASE: 1986058424]
    1. Dreikorn K, Horsch R, Rohl L. A randomized trial with different immunosuppressive regimens after renal transplantation. Transplantation Proceedings 1985;17(6):2663‐5. [EMBASE: 1986055110]
De Backer 1992 {published data only}
    1. Backer D, Abramowicz D, Goldman M, Pauw L, Viseur P, Vanherweghem JL, et al. High or low dose steroid therapy for acute renal transplant rejection after prophylactic OKT3 treatment: a prospective randomized study. Transplant International 1992;5 Suppl 1:S437‐9. [MEDLINE: ] - PubMed
Delucchi 2006 {published data only}
    1. Delucchi B A, Valenzuela A M, Ferrario B M, Lillo D AM, Guerrero G JL, Rodriguez S E, et al. Early steroid withdrawal in pediatric renal transplantation [Retiro precoz de esteroides en la inmunosupresion del trasplante renal pediatrico]. Revista Medica de Chile 2006;134(11):1393‐401. [MEDLINE: ] - PubMed
de Sandes Freitas 2011 {published data only}
    1. Sandes Freitas TV, Harada KM, Felipe CR, Galante NZ, Sampaio EL, Ikehara E, et al. Steroid or tacrolimus withdrawal in renal transplant recipients using sirolimus. International Urology & Nephrology 2011;43(4):1221‐8. [MEDLINE: ] - PubMed
ECSEL Study 2008 {published data only}
    1. Smith MP, Newstead CG, Ahmad N, Lewington AJ, Tibble S, Lodge JP, et al. Poor tolerance of sirolimus in a steroid avoidance regimen for renal transplantation. Transplantation 2008;85(4):636‐9. [MEDLINE: ] - PubMed
    1. Welberry‐Smith MP, Gone K, Tibble S, Littler D, Newstead CG, et al. Poor tolerance of sirolimus in a steroid avoidance regime [abstract no: P37]. British Transplantation Society (BTS). 9th Annual Congress; 2006 Mar 29‐31; Edinburgh, UK. 2006.
Hibbs 2010 {published data only}
    1. Hibbs J, Hamdallah O, Cannon R, Ravindra K, Ouseph R, Gleason J, et al. Alemtuzumab induction with rapid corticosteroid elimination is associated with comparable outcomes in high immunologic risk and non high risk renal transplant recipients [abstract no: 976]. American Journal of Transplantation 2010;10(Suppl 4):322. [EMBASE: 70464352]
Hilbrands 1993 {published data only}
    1. Hilbrands LB, Demacker PN, Hoitsma AJ. Cyclosporin and serum lipids in renal transplant recipients. Lancet 1993;341(8847):765‐6. [MEDLINE: ] - PubMed
    1. Hilbrands LB, Demacker PN, Hoitsma AJ, Stalenhoef AF, Koene RA. The effects of cyclosporine and prednisone on serum lipid and (APO)lipoprotein levels in renal transplant recipients. Journal of the American Society of Nephrology 1995;5(12):2073‐81. [MEDLINE: ] - PubMed
    1. Hilbrands LB, Hoitsma AJ, Koene KA. Randomized, prospective trial of cyclosporine monotherapy versus azathioprine‐prednisone from three months after renal transplantation. Transplantation 1996;61(7):1038‐46. [MEDLINE: ] - PubMed
    1. Hilbrands LB, Hoitsma AJ, Koene RA. Costs of drugs used after renal transplantation. Transplant International 1996;9 Suppl 1:S399‐402. [MEDLINE: ] - PubMed
    1. Hilbrands LB, Hoitsma AJ, Koene RA. Effect of immunosuppressive therapy on quality of life after renal transplantation [abstract]. Journal of the American Society of Nephrology 1994;5(3):1011. [CENTRAL: CN‐00615875]
Hodson 1989 {published data only}
    1. Hodson EM, Knight JF, Sheil AG, Roy LP. Cyclosporin A as sole immunosuppressive agent for renal transplantation in children: effect on catch‐up growth. Transplantation Proceedings 1989;21(1 Pt 2):1687‐92. [MEDLINE: ] - PubMed
Hricik 1993a {published data only}
    1. Hricik DE, Schulak JA. Metabolic effects of steroid withdrawal in adult renal transplant recipients. Kidney International ‐ Supplement 1993;43:S26‐9. [MEDLINE: ] - PubMed
Hricik 1993b {published data only}
    1. Hricik DE, O'Toole MA, Schulak JA, Herson J. Steroid‐free immunosuppression in cyclosporine‐treated renal transplant recipients: a meta‐analysis. Journal of the American Society of Nephrology 1993;4(6):1300‐5. [MEDLINE: ] - PubMed
John 2005 {published data only}
    1. John E, Lumpaopang A, Oberholzer J, Testa G, Sankary H, Benedetti E. Superior outcomes in growth and renal function with early steroid discontinuation in pediatric kidney transplantation: 1 1/2 years follow‐up [abstract no: 1329]. American Journal of Transplantation 2005;5(Suppl 11):494.
Juarez 2006 {published data only}
    1. Juarez FJ, Barrios Y, Cano L, Lopez E, Martinez J, Limones M, et al. A randomized trial comparing two corticosteroid regimens combined with mycophenolate mofetil and cyclosporine for prevention of acute renal allograft rejection. Transplantation Proceedings 2006;38(9):2866‐8. [MEDLINE: ] - PubMed
Kim 2004 {published data only}
    1. Kim B, Huh W, Baek HJ, Lim YH, Yeo HM, Kim JA, et al. Randomized trial of tacrolimus versus cyclosporine in steroid withdrawal in living donor renal transplant recipients [abstract no: SU‐PO523]. Journal of the American Society of Nephrology 2003;14(Nov):648A. [CENTRAL: CN‐00626065]
    1. Kim B, Huh W, Kim MO, Yeo HM, Kim HJ, Kim JA, et al. Randomized trial of tacrolimus versus cyclosporine in steroid withdrawal in living donor renal transplant recipients. Korean Journal of Nephrology 2004;23(5):785‐92. [CENTRAL: CN‐01044957] - PubMed
    1. Kim SJ, Lee KW, Lee DS, Lee HH, Lee SK, Kim B, et al. Randomized trial of tacrolimus versus cyclosporine in steroid withdrawal in living donor renal transplant recipients. Transplantation Proceedings 2004;36(7):2098‐100. [MEDLINE: ] - PubMed
Kim 2005 {published data only}
    1. Kim JS, Aviles DH, Silverstein DM, Leblanc PL, Matti Vehaskari V. Effect of age, ethnicity, and glucocorticoid use on tacrolimus pharmacokinetics in pediatric renal transplant patients. Pediatric Transplantation 2005;9(2):162‐9. [MEDLINE: ] - PubMed
Lehmann 2004 {published data only}
    1. Lehmann R, Weber M, Berthold P, Zullig R, Pfammatter T, Moritz W, et al. Successful simultaneous islet‐kidney transplantation using a steroid‐free immunosuppression: two‐year follow‐up. American Journal of Transplantation 2004;4(7):1117‐23. [MEDLINE: ] - PubMed
Li 2011a {published data only}
    1. Li S, Wang W, Hu X, Ren L, Yin H, Yang X, et al. The effects of early rapid corticosteroid reduction on cell‐mediated immunity in kidney transplant recipients. Transplant Immunology 2011;24(2):127‐30. [MEDLINE: ] - PubMed
    1. Li SH, Wang W, Hu XP, Yin H, Ren L, Yang XY, et al. Monitoring immune function after rapid corticosteroid reduction in kidney transplant recipients. Chinese Medical Journal 2011;124(5):679‐82. [MEDLINE: ] - PubMed
Morris 1982 {published data only}
    1. Morris PJ, Chan L, French ME, Ting A. Low dose oral prednisolone in renal transplantation. Lancet 1982;1(8271):525‐7. [MEDLINE: ] - PubMed
MYSS Study 2004 {published data only}
    1. Gotti E, Perico N, Gaspari F, Cattaneo D, Lesti MD, Ruggenenti P, et al. Blood cyclosporine level soon after kidney transplantation is a major determinant of rejection: insights from the Mycophenolate Steroid‐Sparing Trial. Transplantation Proceedings 2005;37(5):2037‐40. [MEDLINE: ] - PubMed
    1. Perico N, Ruggenenti P, Gotti E, Gaspari F, Cattaneo D, Valente U, et al. In renal transplantation blood cyclosporine levels soon after surgery act as a major determinant of rejection: insights from the MY.S.S. trial. Kidney International 2004;65(3):1084‐90. [MEDLINE: ] - PubMed
    1. Perico N, Ruggenenti P, Gotti E, Gaspari F, Cattaneo D, Valente U, et al. In renal transplantation low blood cyclosporine levels soon after surgery is a determinant of rejection: insights from the MY.S.S. trial [abstract]. Journal of the American Society of Nephrology 2003;14(Nov):11A. [CENTRAL: CN‐00601980]
    1. Remuzzi G, Cravedi P, Costantini M, Lesti M, Ganeva M, Gherardi G, et al. Mycophenolate mofetil versus azathioprine for prevention of chronic allograft dysfunction in renal transplantation: the MYSS follow‐up randomized, controlled clinical trial. Journal of the American Society of Nephrology 2007;18(6):1973‐85. [MEDLINE: ] - PubMed
    1. Remuzzi G, Lesti M, Gotti E, Ganeva M, Dimitrov BD, Ene‐Iordache B, et al. Mycophenolate mofetil versus azathioprine for prevention of acute rejection in renal transplantation (MYSS): a randomised trial. Lancet 2004;364(9433):503‐12. [MEDLINE: ] - PubMed
NCT00089947 {published data only}
    1. NCT00089947. Randomized, prospective, phase 2 study comparing thymoglobulin in a rapid discontinuation of corticosteroids protocol with standard corticosteroid therapy in living donor renal transplantation using mycophenolate mofetil and tacrolimus maintenance therapy. www.clinicaltrials.gov/ct2/show/NCT00089947 (accessed 15 February 2016).
Nori 2008 {published data only}
    1. Nori US, Pesavento TE, Davies EA, Visger J, Miller BS, Ferguson RM. Randomized, prospective prednisone (P) withdrawal trial in kidney transplant patients treated with sirolimus (S) vs microemulsified cyclosporine (CsA) based regimens [abstract no: 458]. American Journal of Transplantation 2008;8(Suppl 2):301. [CENTRAL: CN‐00725014]
Paczek 2003a {published data only}
    1. Paczek L, Wlodarczyk Z, Perner F, Vitko S, Ostrowski M, Bachleda P, et al. Absence of rejection and stable serum creatinine are excellent criteria for steroid‐withdrawal in kidney transplant patients receiving tacrolimus treatment [abstract]. Nephrology Dialysis Transplantation 2003;18(Suppl 4):787‐8. [CENTRAL: CN‐00447076]
Papadakis 1982 {published data only}
    1. Papadakis J, Brown CB, Cameron JS, Adu D, Bewick M, Donaghey R, et al. High versus "low" dose corticosteroids in recipients of cadaveric kidneys: prospective controlled trial. British Medical Journal Clinical Research Ed 1983;286(6371):1097‐100. [MEDLINE: ] - PMC - PubMed
    1. Papadakis JT, Bewick M, Cameron JS, Rudge C, Ogg CS, Brown CB, et al. Low dose steroids in renal transplantation. Lancet 1982;1(8277):916‐7. [MEDLINE: ] - PubMed
Reed 1991 {published data only}
    1. Reed A, Pirsch JD, Armbrust MJ, Burlingham WJ, Knechtle SJ, D'Alessandro AM, et al. A comparison of donor‐specific and random transfusions in living‐related renal transplantation and their effect on steroid withdrawal. Transplantation Proceedings 1991 Feb;23(1 Pt 2):1321‐2. [MEDLINE: ] - PubMed
Remport 2001 {published data only}
    1. Remport A, Sasvari I, Borka P, Toronyi E, Sarvary E, Weszelits W, et al. Comparative analysis of mycophenolate‐mofetil‐cyclosporin immunosuppression of kidney transplantation recipients with two different corticosteroid doses and conventional cyclosporin‐corticosteroid therapy [abstract]. XVIII International Congress of the Transplantation Society; 2000 Aug 27‐Sept 1; Rome, Italy. 2000. [CENTRAL: CN‐00447378]
    1. Remport A, Sasvari I, Borka P, Toronyi E, Sarvary E, Weszelits W, et al. Evaluation of the effect of different corticosteroid doses in combination with mycophenolate‐mofetil‐cyclosporin immunosuppression in kidney transplanted recipients [abstract]. Nephrology Dialysis Transplantation 2000;15(9):A256. [CENTRAL: CN‐00461586]
    1. Remport A, Sasvari I, Toronyi E, Borka P, Lazar N, Jaray J, et al. Mycofenolate mofetil‐cyclosporine immunosuppression of kidney transplantation recipients with two different corticosteroid doses. Transplantation Proceedings 2001;33(3):2302‐3. [MEDLINE: ] - PubMed
Robertson 1980 {published data only}
    1. Robertson AJ, Gibbs J, Potts R, Brown RA, Browning MC, Beck JS. Renal transplant rejection after gradual withdrawal of prednisolone. British Medical Journal 1980;281(6235):305‐6. [MEDLINE: ] - PMC - PubMed
Sarwal 2012 {published data only}
    1. Chaudhuri A, Ozawa M, Everly MJ, Ettenger R, Dharnidharka V, Benfield M, et al. The clinical impact of humoral immunity in pediatric renal transplantation. Journal of the American Society of Nephrology 2013;24(4):655‐64. [MEDLINE: ] - PMC - PubMed
    1. Kambham N, Naesens M, Sigdel T, Waskerwitz J, Salvatierra O, Sarwal M. A protocol biopsy analysis from an NIH multicenter pediatric renal transplant trial reveals no adverse effect of steroid avoidance on the histological evolution of chronic graft injury [abstract no: LB01]. American Journal of Transplantation 2008;8(Suppl 2):334.
    1. Naesens M, Kambham N, Sigdel T, Waskerwitz J, Salvatierra O, Sarwal M. A protocol biopsy analysis from an NIH multicenter pediatric renal transplant trial revels no adverse effect of steroid avoidance on the histological evolution of chronic graft injury [abstract no: 54]. Transplantation 2008;86(2S):18.
    1. Naesens M, Salvatierra O, Benfield M, Ettenger RB, Dharnidharka V, Harmon W, et al. Subclinical inflammation and chronic renal allograft injury in a randomized trial on steroid avoidance in pediatric kidney transplantation. American Journal of Transplantation 2012;12(10):2730‐43. [MEDLINE: ] - PMC - PubMed
    1. Sarwal M, Benfield M, Ettenger R, Dharnidharka V, Mathias R, McDonald R, et al. One year results of a prospective, randomized, multicenter trial of steroid avoidance in pediatric renal transplantation [abstract no: 52]. American Journal of Transplantation 2008;8(Suppl 2):192.
SENIOR Study 2009 {published data only}
    1. Andres A, Budde K, Clavien PA, Becker T, Kessler M, Pisarski P, et al. A randomized trial comparing renal function in older kidney transplant patients following delayed versus immediate tacrolimus administration. Transplantation 2009;88(9):1101‐8. [MEDLINE: ] - PubMed
Shapiro 1993 {published data only}
    1. Shapiro R, Jordan M, Scantlebury V, Vivas C, Fung J, McCauley J, et al. A prospective, randomized trial of FK‐506 in renal transplantation‐‐a comparison between double‐ and triple‐drug therapy. Clinical Transplantation 1994;8(6):508‐15. [MEDLINE: ] - PMC - PubMed
    1. Shapiro R, Jordan ML, Scantlebury VP, Fung JJ, Jensen C, Vivas C, et al. Randomized trial of FK 506/prednisone vs FK 506/azathioprine/prednisone after renal transplantation: preliminary report. Transplantation Proceedings 1993;25(1 Pt 1):669‐72. [MEDLINE: ] - PMC - PubMed
    1. Shapiro R, Jordan ML, Scantlebury VP, Vivas C, Fung JJ, McCauley J, et al. A prospective randomized trial of FK506‐based immunosuppression after renal transplantation. Transplantation 1995;59(4):485‐90. [MEDLINE: ] - PMC - PubMed
    1. Shapiro R, Jordan ML, Scantlebury VP, Vivas C, Fung JJ, McCauley J, et al. A prospective, randomized trial of FK 506/prednisone vs FK 506/azathioprine/prednisone in renal transplant patients. Transplantation Proceedings 1995;27(1):814‐7. [MEDLINE: ] - PMC - PubMed
    1. Shapiro R, Jordan ML, Scantlebury VP, Vivas C, Gitsch HA, McCauley J, et al. The outcome after steroid withdrawal in renal transplant patients receiving tacrolimus‐based immunosuppression [abstract no: 188]. 16th Annual Meeting. American Society of Transplant Physicians (ASTP); 1997 May 10‐14; Chicago (ILL). 1997:131. [CENTRAL: CN‐00509473]
Silverstein 2005 {published data only}
    1. Silverstein DM, Aviles DH, LeBlanc PM, Jung FF, Vehaskari VM. Results of one‐year follow‐up of steroid‐free immunosuppression in pediatric renal transplant patients. Pediatric Transplantation 2005;9(5):589‐97. [MEDLINE: ] - PubMed
SOCRATES Study 2014 {published data only}
    1. Chadban SJ, Eris JM, Kanellis J, Pilmore H, Lee PC, Lim SK, et al. A randomized, controlled trial of everolimus‐based dual immunosuppression versus standard of care in de novo kidney transplant recipients. Transplant International 2014;27(3):302‐11. [MEDLINE: ] - PMC - PubMed
    1. 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]. Transplantation Society of Australia & New Zealand (TSANZ). 30th Annual Scientific Meeting; 2012 Jun 27‐29; Canberra (ACT). 2012:103.
Tarantino 1991 {published data only}
    1. Tarantino A, Aroldi A, Stucchi L, Montagnino G, Mascaretti L, Vegeto A, et al. A randomized prospective trial comparing cyclosporine monotherapy with triple‐drug therapy in renal transplantation. Transplantation 1991;52(1):53‐7. [MEDLINE: ] - PubMed
Teplan 2003 {published data only}
    1. Teplan V, Schuck O, Stollova M, Vitko S. Obesity and hyperhomocysteinaemia after kidney transplantation. Nephrology Dialysis Transplantation 2003;18 Suppl 5:v71‐3. [MEDLINE: ] - PubMed
ter Meulen 2002 {published data only}
    1. Hendrikx TK, Klepper M, Ijzermans J, Weimar W, Baan CC. Clinical rejection and persistent immune regulation in kidney transplant patients. Transplant Immunology 2009;21(3):129‐35. [MEDLINE: ] - PubMed
    1. Hesselink DA, Ngyuen H, Wabbijn M, Gregoor PJ, Steyerberg EW, Riemsdijk IC, et al. Tacrolimus dose requirement in renal transplant recipients is significantly higher when used in combination with corticosteroids. British Journal of Clinical Pharmacology 2003;56(3):327‐30. [MEDLINE: ] - PMC - PubMed
    1. Hesselink DA, Ngyuen H, Wabbijn M, Smak Gregoor PJH, Steyerberg EW, Riemsdijk IC, et al. Tacrolimus dose requirement in renal transplant recipients is significantly higher when used in combination with corticosteroids [abstract]. American Journal of Transplantation 2003;3(Suppl 5):482. - PMC - PubMed
    1. ter Meulen CG, Goertz JH, Klasen IS, Verweij CM, Hilbrands LB, Wetzels JF, et al. Decreased renal excretion of soluble interleukin‐2 receptor alpha after treatment with daclizumab. Kidney International 2003;64(2):697‐703. [MEDLINE: ] - PubMed
    1. ter Meulen CG, Hilbrands LB, Bergh JP, Hermus AR, Hoitsma AJ. The influence of corticosteroids on quantitative ultrasound parameters of the calcaneus in the 1st year after renal transplantation. Osteoporosis International 2005;16(3):255‐62. [MEDLINE: ] - PubMed
TRIMS Study 2010 {published data only}
    1. Woodle ES, Peddi VR, Tomlanovich S, Mulgaonkar S, Kuo PC, TRIMS Study Investigators. A prospective, randomized, multicenter study evaluating early corticosteroid withdrawal with Thymoglobulin in living‐donor kidney transplantation. Clinical Transplantation 2010;24(1):73‐83. [MEDLINE: ] - PubMed
    1. Woodle ES, TRIMS Study Group. A randomized, prospective, multicenter comparative study evaluating a thymoglobulin‐based early corticosteroid cessation regime in renal transplantation [abstract no: 673]. American Journal of Transplantation 2006;6(Suppl 2):294. [CENTRAL: CN‐00716028]
    1. Woodle ES, TRIMS Study Group. A randomized, prospective, multicenter study of thymoglobulin in renal transplantation for induction and minimization of steroids (TRIMS) [abstract no: 1632]. American Journal of Transplantation 2005;5(Suppl 11):571. [CENTRAL: CN‐00716027]
TWIST Study 2010 {published data only}
    1. Billing H, Hoecker B, Fichtner A, Damme‐Lombaerts R, Friman S, Jaray J, et al. Single nucleotide polymorphism of CYP3A5 influences the exposure to tacrolimus in pediatric renal transplant recipients: A pharmacogenetic substudy of the TWIST trial [abstract]. Transplantation 2014;98(Suppl 1):147. [EMBASE: 71543993]
    1. Billing H, Sander A, Susal C, Ovens J, Feneberg R, Hocker B, et al. Soluble CD30 and ELISA‐detected human leukocyte antigen antibodies for the prediction of acute rejection in pediatric renal transplant recipients. Transplant International 2013 Mar;26(3):331‐8. [MEDLINE: ] - PubMed
    1. Feneberg R. Single nucleotide polymorphisms of CYP3A5, but not of other genes, influence the exposure to tacrolimus in paediatric renal transplant recipients: a pharmacognetic substudy of the Twist Study [abstract no: SAT‐M‐130]. Transplantation Society of Australia & New Zealand (TSANZ). 27th Annual Meeting; 2009 Jun 17‐19; Canberra (ACT). 2009:121.
    1. Grenda R, Watson A, Trompeter R, Tonshoff B, Jaray J, Fitzpatrick M, et al. A randomized trial to assess the impact of early steroid withdrawal on growth in pediatric renal transplantation: the TWIST study. American Journal of Transplantation 2010;10(4):828‐36. [MEDLINE: ] - PubMed
    1. Trompeter RS, Grenda R, Watson A. Improved growth in pediatric kidney recipients after early steroid withdrawal: daclizumab, tacrolimus (TAC) and mycophenolate mofetil (MMF) versus TAC, MMF and steroids (TWIST Study) [abstract no: 604]. American Journal of Transplantation 2009;9(Suppl 2):365. [EMBASE: 70010477]
Weimert 2008 {published data only}
    1. Weimert N, Alloway R, Vinks A, Rike A, Young S, Cardi M, et al. A 12‐month, prospective, randomized, single center, open label pilot study to evaluate the safety and efficacy of Myfortic® in combination with tacrolimus and thymoglobulin® in early corticosteroid withdrawal [abstract no: 102]. Transplantation 2008;86(2 Suppl):36.

References to studies awaiting assessment

Newstead 1989 {published data only}
    1. Newstead C, Moore R, et al. Renal transplant function after steroid withdrawal from triple immunosuppression [abstract]. Nephrology Dialysis Transplantation 1989;4:518. [CENTRAL: CN‐00260463]

Additional references

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References to other published versions of this review

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