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Meta-Analysis
. 2020 Mar 12;3(3):CD003965.
doi: 10.1002/14651858.CD003965.pub3.

Immunosuppressive agents for treating IgA nephropathy

Patrizia Natale  1   2 , Suetonia C Palmer  3 , Marinella Ruospo  1   2 , Valeria M Saglimbene  1   2 , Jonathan C Craig  4   5 , Mariacristina Vecchio  6 , Joshua A Samuels  7 , Donald A Molony  8 , Francesco Paolo Schena  1 , Giovanni Fm Strippoli  1   2   4
Affiliations
Meta-Analysis

Immunosuppressive agents for treating IgA nephropathy

Patrizia Natale et al. Cochrane Database Syst Rev. .

Abstract

Background: IgA nephropathy is the most common glomerulonephritis world-wide. IgA nephropathy causes end-stage kidney disease (ESKD) in 15% to 20% of affected patients within 10 years and in 30% to 40% of patients within 20 years from the onset of disease. This is an update of a Cochrane review first published in 2003 and updated in 2015.

Objectives: To determine the benefits and harms of immunosuppression strategies for the treatment of IgA nephropathy.

Search methods: We searched the Cochrane Kidney and Transplant Register of Studies up to 9 September 2019 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 Register (ICTRP) Search Portal and ClinicalTrials.gov.

Selection criteria: We included randomised controlled trials (RCTs) and quasi-RCTs of treatment for IgA nephropathy in adults and children and that compared immunosuppressive agents with placebo, no treatment, or other immunosuppressive or non-immunosuppressive agents.

Data collection and analysis: Two authors independently assessed study risk of bias and extracted data. Estimates of treatment effect were summarised using random effects meta-analysis. Treatment effects were expressed as relative risk (RR) and 95% confidence intervals (95% CI) for dichotomous outcomes and mean difference (MD) and 95% CI for continuous outcomes. Risks of bias were assessed using the Cochrane tool. Evidence certainty was evaluated using GRADE methodology.

Main results: Fifty-eight studies involving 3933 randomised participants were included. Six studies involving children were eligible. Disease characteristics (kidney function and level of proteinuria) were heterogeneous across studies. Studies evaluating steroid therapy generally included patients with protein excretion of 1 g/day or more. Risk of bias within the included studies was generally high or unclear for many of the assessed methodological domains. In patients with IgA nephropathy and proteinuria > 1 g/day, steroid therapy given for generally two to four months with a tapering course probably prevents the progression to ESKD compared to placebo or standard care (8 studies; 741 participants: RR 0.39, 95% CI 0.23 to 0.65; moderate certainty evidence). Steroid therapy may induce complete remission (4 studies, 305 participants: RR 1.76, 95% CI 1.03 to 3.01; low certainty evidence), prevent doubling of serum creatinine (SCr) (7 studies, 404 participants: RR 0.43, 95% CI 0.29 to 0.65; low certainty evidence), and may lower urinary protein excretion (10 studies, 705 participants: MD -0.58 g/24 h, 95% CI -0.84 to -0.33;low certainty evidence). Steroid therapy had uncertain effects on glomerular filtration rate (GFR), death, infection and malignancy. The risk of adverse events with steroid therapy was uncertain due to heterogeneity in the type of steroid treatment used and the rarity of events. Cytotoxic agents (azathioprine (AZA) or cyclophosphamide (CPA) alone or with concomitant steroid therapy had uncertain effects on ESKD (7 studies, 463 participants: RR 0.63, 95% CI 0.33 to 1.20; low certainty evidence), complete remission (5 studies; 381 participants: RR 1.47, 95% CI 0.94 to 2.30; very low certainty evidence), GFR (any measure), and protein excretion. Doubling of serum creatinine was not reported. Mycophenolate mofetil (MMF) had uncertain effects on the progression to ESKD, complete remission, doubling of SCr, GFR, protein excretion, infection, and malignancy. Death was not reported. Calcineurin inhibitors compared with placebo or standard care had uncertain effects on complete remission, SCr, GFR, protein excretion, infection, and malignancy. ESKD and death were not reported. Mizoribine administered with renin-angiotensin system inhibitor treatment had uncertain effects on progression to ESKD, complete remission, GFR, protein excretion, infection, and malignancy. Death and SCr were not reported. Leflunomide followed by a tapering course with oral prednisone compared to prednisone had uncertain effects on the progression to ESKD, complete remission, doubling of SCr, GFR, protein excretion, and infection. Death and malignancy were not reported. Effects of other immunosuppressive regimens (including steroid plus non-immunosuppressive agents or mTOR inhibitors) were inconclusive primarily due to insufficient data from the individual studies in low or very low certainty evidence. The effects of treatments on death, malignancy, reduction in GFR at least of 25% and adverse events were very uncertain. Subgroup analyses to determine the impact of specific patient characteristics such as ethnicity or disease severity on treatment effectiveness were not possible.

Authors' conclusions: In moderate certainty evidence, corticosteroid therapy probably prevents decline in GFR or doubling of SCr in adults and children with IgA nephropathy and proteinuria. Evidence for treatment effects of immunosuppressive agents on death, infection, and malignancy is generally sparse or low-quality. Steroid therapy has uncertain adverse effects due to a paucity of studies. Available studies are few, small, have high risk of bias and generally do not systematically identify treatment-related harms. Subgroup analyses to identify specific patient characteristics that might predict better response to therapy were not possible due to a lack of studies. There is no evidence that other immunosuppressive agents including CPA, AZA, or MMF improve clinical outcomes in IgA nephropathy.

PubMed Disclaimer

Conflict of interest statement

No author has a vested interest in any of the products or procedures included in the analysis.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Lafayette 2017 {published data only}
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    1. Hogg RJ, Fitzgibbons L, Atkins C, Nardelli N, Bay RC, North American IgA Nephropathy Study Group. Efficacy of omega‐3 fatty acids in children and adults with IgA nephropathy is dosage‐ and size‐dependent. Clinical Journal of the American Society of Nephrology: CJASN 2006;1(6):1167‐72. [MEDLINE: ] - PubMed
    1. Hogg RJ, Lee J, Nardelli N, Julian BA, Cattran D, Waldo B, et al. Clinical trial to evaluate omega‐3 fatty acids and alternate day prednisone in patients with IgA nephropathy: report from the Southwest Pediatric Nephrology Study Group. Clinical Journal of the American Society of Nephrology: CJASN 2006;1(3):467‐74. [MEDLINE: ] - PubMed
    1. Hogg RJ, Lee J, Nardelli NA, Cattran D, Hirschman G, Julian BA. Clinical trial of alternate‐day prednisone or daily omega‐3 fatty acids in patients with IgA nephropathy [abstract no: OFC10]. Pediatric Nephrology 2004;19(9):C64. [CENTRAL: CN‐00583302]
NEFIGAN 2017 {published data only}
    1. Bhachu JS, Scionti K, Muto M, Molyneux K, Barratt J. Targeted release‐budesonide (NEFECON) modifies circulating IGA‐IGG immune complex levels and levels of poorly O‐galactosylated IgA in IgAN [abstract]. Kidney Diseases 2018;4(3):121‐2. [EMBASE: 624087998]
    1. Fellstrom B, Barratt J, Cook H, Coppo R, Feehally J, Fijter J, et al. Proteinuria reduction in IgA nephropathy by nefecon, a targeted release formulation of budesonide ‐ results from the NEFIGAN trial [abstract no: TO013]. Nephrology Dialysis Transplantation 2017;32(Suppl 3):iii82‐3. [EMBASE: 617291389]
    1. Fellstrom B, Barratt J, Floege J. Treatment of IgA nephropathy with nefecon, a targeted‐release formulation of budesonide‐extended posthoc results from the NEFIGAN trial [abstract]. Kidney Diseases 2018;4(3):140. [EMBASE: 624069810]
    1. Fellstrom B, Coppo R, Feehally J, Floege J, Jardine A, Locatelli F, et al. The NEFIGAN trial: a randomized, placebo‐controlled study to evaluate the efficacy and safety of NEFECON in IgA nephropathy patients at risk of developing ESRD: preliminary data from the run‐in phase [abstract no: TH‐PO442]. Journal of the American Society of Nephrology 2014;25(Abstracts):207A. [CENTRAL: CN‐01658027]
    1. Fellstrom B, Coppo R, Feehally J, Floege J, Fijter JW, Jardine AG, et al. The NEFIGAN trial: NEFECON, a novel targeted release formulation of budesonide, reduces proteinuria and stabilizes eGFR in IgA nephropathy patients at risk of ESRD [abstract no: HI‐OR04]. Journal of the American Society of Nephrology 2015;26(Abstracts):B1. [CENTRAL: CN‐01658026]
Ni 2005 {published data only}
    1. Ni Z, Qian J, Lu F, Jiang G, He L, Yao J, et al. Leflunomide plus low dose prednisone could reduce proteinuria and stabilize kidney function in progressive IgA nephropathy at 2 year follow‐up study [abstract no: F‐PO1967]. Journal of the American Society of Nephrology 2008;19(Abstracts Issue):555A. [CENTRAL: CN‐00740503]
    1. Ni Z, Qian JQ, Lu F, Yao J, Yuan WJ, Zhu H, et al. Leflunomide plus low dose prednisone therapy in progressive IgA nephropathy at 2 year follow‐up: a multi‐center, perspective, randomized control study [abstract no: SU‐PO1054]. Journal of the American Society of Nephrology 2007;18(Abstracts Issue):819A. [CENTRAL: CN‐00740500]
    1. Ni Z, Qian JQ, Lu F, Yao J, Yuan WJ, Zhu W, et al. Leflunomide treatment in progressive IgA nephropathy: interim analysis from a multi‐center, perspective, randomized control study [abstract no: SA‐PO1080]. Journal of the American Society of Nephrology 2006;17(Abstracts):800A. [CENTRAL: CN‐00740499]
    1. Ni Z, Qian JQ, Lu FM, Yao J, He L, Zhu H, et al. Leflunomide treatment in progressive IgA nephropathy: preliminary results from a multi‐center, perspective, randomized control study [abstract no: F‐PO859]. Journal of the American Society of Nephrology 2005;16:523A. [CENTRAL: CN‐00740496]
Nuzzi 2009 {published data only}
    1. Nuzzi F, D'Armiento M, Balletta MM, Malgieri G, Pecoraro C. Early corticosteroid treatment (CT) in children with IgA nephropathy (IGAn): a randomized and controlled trial [abstract]. Pediatric Nephrology 2010;25(9):1880. [EMBASE: 70438531]
    1. Nuzzi F, D'Armiento M, Malgieri G, Ferretti A, Marzano L, Pecoraro C. Early corticosteroid treatment in children with IGA nephropathy: a randomized and controlled trial [abstract no: OC005]. 27th Annual Scientific Meeting; Transplantation Society of Australia & New Zealand; 2009 June 17‐19; Canberra, Australia. 2009:28. [CENTRAL: CN‐00756254]
Pozzi 1999 {published data only}
    1. Vecchio L, Pozzi C, Fogazzi GB, Andrulli S, Pani A, Rustichelli R, et al. Renal histological picture and steroid treatment in IGA nephropathy [abstract no: SU‐PO984]. Journal of the American Society of Nephrology 2003;14(Nov):752A. [CENTRAL: CN‐00447275]
    1. Locatelli F, Pozzi C, Vecchio L, Bolasco PG, Fogazzi GB, Andrulli S, et al. Role of proteinuria reduction in the progression of IgA nephropathy. Renal Failure 2001;23(3‐4):495‐505. [MEDLINE: ] - PubMed
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    1. Pozzi C, Andrulli S, Vecchio L, Melis P, Fogazzi GB, Altieri P, et al. Corticosteroid effectiveness in IgA nephropathy: long‐term results of a randomized, controlled trial. Journal of the American Society of Nephrology 2004;15(1):157‐63. [MEDLINE: ] - PubMed
    1. Pozzi C, Bolasco PG, Fogazzi GB, Andrulli S, Altieri P, Ponticelli C, et al. Corticosteroids in IgA nephropathy: a randomised controlled trial. Lancet 1999;353(9156):883‐7. [MEDLINE: ] - PubMed
Segarra 2006 {published data only}
    1. Segarra A, Vila J, Montoro B, Sunye P, Calero F, Orfila MA, et al. A multicenter randomized study to analyze the efficacy and safety of high‐dose immunoglobulin therapy associated with steroids vs steroid monotherapy in patients with IgA nephropathy [abstract no: MP085]. Nephrology Dialysis Transplantation 2006;21(Suppl 4):iv327. [CENTRAL: CN‐00755295]
Shen 2013 {published data only}
    1. Shen P, Li Y, Wang Z, Wang W, Ren H, Zhang W, et al. A prospective randomized study on the efficacy of corticosteroid combined with cyclophosphamide or FK506 in primary IGA nephropathy with mild or moderate renal injury [abstract no: SP308]. Nephrology Dialysis Transplantation 2013;28(Suppl 1):i175. [EMBASE: 71075508]
Shi 2012a {published data only}
    1. Shi B, Ni Z, Cao L, Mou S, Zhang M, Wang Q, et al. Mannose‐binding lectin gene polymorphism may predict response to leflunomide in patients with progressive IgA nephropathy [abstract no: FR‐PO819]. Journal of the American Society of Nephrology 2012;23(Abstract Suppl):556A.
Shima 2018 {published data only}
    1. Shima Y, Nakanishi K, Kaku Y, Ishikura K, Hataya H, Matsuyama T, et al. Combination therapy with or without warfarin and dipyridamole for severe childhood IgA nephropathy: an RCT. Pediatric Nephrology 2018;33(11):2103‐12. [MEDLINE: ] - PubMed
Shoji 2000 {published data only}
    1. Shoji T, Nakanishi I, Saito N, Hayashi T, Togawa M, Okada N, et al. The corticosteroid treatment of diffuse mesangial proliferative IgA nephropathy: a one‐year prospective trial [abstract no: A0466]. Journal of the American Society of Nephrology 1997;8(Program & Abstracts):98A.
    1. Shoji T, Nakanishi I, Suzuki A, Hayashi T, Togawa M, Okada N, et al. Early treatment with corticosteroids ameliorates proteinuria, proliferative lesions, and mesangial phenotypic modulation in adult diffuse proliferative IgA nephropathy. American Journal of Kidney Diseases 2000;35(2):194‐201. [MEDLINE: ] - PubMed
Stangou 2011 {published data only}
    1. Stangou M, Ekonomidou D, Giamalis P, Liakou H, Tsiantoulas A, Pantzaki A, et al. Steroids and azathioprine in the treatment of IgA nephropathy. Clinical & Experimental Nephrology 2011;15(3):373‐80. [MEDLINE: ] - PubMed
STOP‐IgAN 2008 {published data only}
    1. Eitner F, Ackermann D, Hilgers RD, Floege J. Supportive versus immunosuppressive therapy of progressive IgA nephropathy (STOP) IgAN trial: rationale and study protocol. Journal of Nephrology 2008;21(3):284‐9. [MEDLINE: ] - PubMed
    1. Floege J, Rauen T, Eitner F, Fitzner C, Hilgers RD. Corticosteroid monotherapy versus combined immunosuppression in IgA nephropathy: insights from the STOP‐IgAN trial [abstract no: SA‐PO1097]. Journal of the American Society of Nephrology 2015;26(Abstracts):B4‐5. [CENTRAL: CN‐01658032]
    1. Floege J, Rauen T, Eitner F, Fitzner C, Sommerer C, Zeier M, et al. Supportive versus immunosuppressive therapy for progressive IgA nephropathy (STOP‐IGAN): a randomized, controlled, open‐label multicenter trial [abstract]. 52nd Congress ERA‐EDTA; 2015 May 28‐31; London, UK. 2015. [CENTRAL: CN‐01658031]
    1. Floege J, Rauen T, Schindler J, Fitzner C, Eitner F, Groene HJ, et al. The MEST kidney biopsy score predicts renal outcome in STOP‐IgAN trial patients ‐ a post‐hoc study [abstract no: TH‐OR057]. Journal of the American Society of Nephrology 2016;27(Abstract Suppl):14A. [CENTRAL: CN‐01658030]
    1. Lennartz D, Rauen T, Fitzner C, Eitner F, Hilgers RD, Floege J. Dual blockade of the renin‐angiotensin system in patients with IgA nephropathy ‐ insights from the STOP‐IGAN Trial [abstract no: SUN‐021]. Kidney International Reports 2019;4(7 Suppl):S161. [EMBASE: 2002179482]
Takeda 1999 {published data only}
    1. Takeda T, Muso E, Maeda M, Ono T, Higashi Y, Takeshita K, et al. Two‐year randomized controlled trial of steroid therapy for adult patients with moderately active IgA nephropathy (IgAN) [abstract no: A0463]. Journal of the American Society of Nephrology 1999;10(Program & Abstracts):90A‐1A. [CENTRAL: CN‐00583221]
Tang 2005 {published data only}
    1. Tang S, Leung JC, Chan LY, Lui YH, Tang CS, Kan CH, et al. Mycophenolate mofetil alleviates persistent proteinuria in IgA nephropathy. Kidney International 2005;68(2):802‐12. [MEDLINE: ] - PubMed
    1. Tang S, Leung JC, Tang AW, Ho YW, Chan LY, Chan TM, et al. A prospective, randomized, case‐controlled study on the efficacy of mycophenolate mofetil (MMF) for IgA nephropathy (IgAN) patients with persistent proteinuria despite angiotensin blockade [abstract no: SU‐PO986]. Journal of the American Society of Nephrology 2003;14(Nov):752A. [CENTRAL: CN‐00583218]
    1. Tang SC, Tang AW, Wong SS, Leung JC, Ho YW, Lai KN. Long‐term study of mycophenolate mofetil treatment in IgA nephropathy. Kidney International 2010;77(6):543‐9. [MEDLINE: ] - PubMed
TESTING 2017 {published data only}
    1. Lv J, Zhang H, Perkovic V, TESTING Study Group. The therapeutic evaluation of steroids in IgA nephropathy global (TESTING) study [abstract no: LB01]. 53rd Congress ERA‐EDTA; 2016 May 21‐24; Vienna, Austria. 2016. [CENTRAL: CN‐01658019]
    1. Lv J, Zhang H, Wong MG, Jardine MJ, Hladunewich M, Jha V, et al. Effect of oral methylprednisolone on clinical outcomes in patients with IgA nephropathy: the TESTING randomized clinical trial. JAMA 2017;318(5):432‐42. [MEDLINE: ] - PMC - PubMed
Walker 1990a {published data only}
    1. Walker RG, Yu SH, Owen JE, Kincaid‐Smith P. The treatment of mesangial IgA nephropathy with cyclophosphamide, dipyridamole and warfarin: a two‐year prospective trial. Clinical Nephrology 1990;34(3):103‐7. [MEDLINE: ] - PubMed
Welch 1992 {published data only}
    1. Welch TR, Fryer C, Shely E, Witte DP, Quinlan M. Double‐blind, controlled trial of short‐term prednisone therapy in immunoglobulin A glomerulonephritis. Journal of Pediatrics 1992;121(3):474‐7. [MEDLINE: ] - PubMed
Woo 1987 {published data only}
    1. Woo KT, Chiang GS, Lim CH. Follow‐up renal biopsies in IgA nephritic patients on triple therapy. Clinical Nephrology 1987;28(6):304‐5. [MEDLINE: ] - PubMed
    1. Woo KT, Chiang GS, Yap HK, Lim CH. Controlled therapeutic trial of IgA nephritis with follow‐up renal biopsies. Annals of the Academy of Medicine, Singapore 1988;17(2):226‐31. [MEDLINE: ] - PubMed
    1. Woo KT, Edmondson RP, Yap HK, Wu AY, Chiang GS, Lee EJ, et al. Effects of triple therapy on the progression of mesangial proliferative glomerulonephritis. Clinical Nephrology 1987;27(2):56‐64. [MEDLINE: ] - PubMed
    1. Woo KT, Lee GS, Lau YK, Chiang GS, Lim CH. Effects of triple therapy in IgA nephritis: a follow‐up study 5 years later. Clinical Nephrology 1991;36(2):60‐6. [MEDLINE: ] - PubMed
    1. Woo KT, Lee GS, Lau YK, Chiang GSC Lim CH. Anti platelet therapy in IgA nephritis [abstract]. 11th International Congress of Nephrology; 1990 Jul 15‐20; Tokyo, Japan. 1990:13. [CENTRAL: CN‐00448412]
Wu 2016 {published data only}
    1. Chen XM, Wu J, Duan S, Zheng Y. Efficacy and safety of telmisartan, clopidogrelin and leflunomide in patients with IgA nephropathy ‐ a multicentre, prospective, randomized, double‐blind, double‐dummy controlled clinical trial [abstract no: SA‐PO848]. Journal of the American Society of Nephrology 2013;24(Abstracts):821A. [CENTRAL: CN‐01658021]
    1. Wu J, Duan S, Li W, Wang Y, Liu W, Zhang J, et al. Efficacy and safety of telmisartan, clopidogrelin, and leflunomide in patients with IgA nephropathy ‐ a multicentre, prospective, randomized, double‐blind and‐dummy controlled clinical trial [abstract no: SP307]. Nephrology Dialysis Transplantation 2013;28(Suppl 1):i175. [EMBASE: 71075507]
    1. Wu J, Duan SW, Sun XF, Li WG, Wang YP, Liu WH, et al. Efficacy of leflunomide, telmisartan, and clopidogrel for immunoglobulin A nephropathy: a randomized controlled trial. Chinese Medical Journal 2016;129(16):1894‐903. [MEDLINE: ] - PMC - PubMed
Xie 2011 {published data only}
    1. Xie Y, Huang S, Wang L, Miao L, Zhang A, Li Y, et al. Efficacy and safety of mizoribine combined with losartan in the treatment of IgA nephropathy: a multicenter, randomized, controlled study. American Journal of the Medical Sciences 2011;341(5):367‐72. [MEDLINE: ] - PubMed
Yamauchi 2001 {published data only}
    1. Yamauchi A, Uzu T, Yamato M, Ko M, Takahara K. Effect of steroid therapy on the progression of IgA nephropathy [abstract no: A1329]. Journal of the American Society of Nephrology 2001;12(Program & Abstracts):259A. [CENTRAL: CN‐00448450]
Yoshikawa 1999 {published data only}
    1. Ito H, Yoshikawa N. Prospective multicenter controlled therapeutic trial in IgA nephropathy in Japanese children: a preliminary report [abstract no: S‐I‐2]. Pediatric Nephrology 1992;6(6):C208. [CENTRAL: CN‐01658022]
    1. Kamei K, Nakanishi K, Ito S, Saito M, Sako M, Ishikura K, et al. Long‐term results of a randomized controlled trial in childhood IgA nephropathy. Clinical Journal of the American Society of Nephrology: CJASN 2011;6(6):1301‐7. [MEDLINE: ] - PMC - PubMed
    1. Yoshikawa N, Ito H. Combined therapy with prednisolone, azathioprine, heparin‐warfarin, and dipyridamole for paediatric patients with severe IgA nephropathy‐‐is it relevant for adult patients?. Nephrology Dialysis Transplantation 1999;14(5):1097‐9. [MEDLINE: ] - PubMed
    1. Yoshikawa N, Ito H. Corticosteroids and immunosuppressive drugs [abstract]. Pediatric Nephrology 2001;16(8):C31. [CENTRAL: CN‐00448482]
    1. Yoshikawa N, Ito H, Sakai T, Takekoshi Y, Honda M, Awazu, M, et al. A controlled trial of combined therapy for newly diagnosed severe childhood IgA nephropathy. The Japanese Pediatric IgA Nephropathy Treatment Study Group. Journal of the American Society of Nephrology 1999;10(1):101‐9. [MEDLINE: ] - PubMed
Yoshikawa 2006 {published data only}
    1. Yoshikawa N. Treatment of IGA nephropathy in children [abstract no: FCP04]. Pediatric Nephrology 2004;19(9):C57. [CENTRAL: CN‐00583685]
    1. Yoshikawa N, Honda M, Iijima K, Awazu M, Hattori S, Nakanishi K, et al. Steroid treatment for severe childhood IgA nephropathy: a randomized, controlled trial. Clinical Journal of the American Society of Nephrology: CJASN 2006;1(3):511‐7. [MEDLINE: ] - PubMed
    1. Yoshikawa N, Ito H. Corticosteroids and immunosuppressive drugs [abstract]. Pediatric Nephrology 2001;16(8):C31. [CENTRAL: CN‐00448482]
    1. Yoshikawa N, Ito H. Prednisolone therapy versus combined therapy with prednisolone, azathioprine, warfarin and dipyridamole for newly diagnosed severe childhood IgA nephropathy: a controlled trial by the Japanese Pediatric IgA Nephropathy Treatment study group [abstract no: A0430]. Journal of the American Society of Nephrology 2000;11(Sept):79A. [CENTRAL: CN‐00550736] - PubMed
Zhang 2004 {published data only}
    1. Zhang XZ, He Q, Luo TC, Lin ST. Efficacy and safety of leflunomide in the treatment of IgA nephropathy: preliminary results from a randomized, corticosteroid controlled, multi‐center clinical trial [abstract no: SA‐PO168]. Journal of the American Society of Nephrology 2004;15(Oct):337A. [CENTRAL: CN‐00583916]
    1. Zhang XZ, He YC, Luo Q, Yang TC, Li XG, Lin SY. Efficacy and safety of leflunomide in the treatment of IgA nephropathy: a perspective, corticosteroid controlled, multi‐center clinical trial [abstract no: F‐PO1097]. Journal of the American Society of Nephrology 2006;17(Abstracts):567A. [CENTRAL: CN‐00644205]

References to studies excluded from this review

Chen 2009b {published data only}
    1. Chen Y, Qin Y. Clinical effects of triple therapy in treatment of IgA nephropathy patients with moderate proteinuria. Xian Dai Yi Yao Wei Sheng 2009;25:1645‐6. [CENTRAL: CN‐01912326]
Czock 2007 {published data only}
    1. Czock D, Rasche FM, Carius A, Glander P, Budde K, Bauer S, et al. Pharmacokinetics and pharmacodynamics of mycophenolic acid after enteric‐coated mycophenolate versus mycophenolate mofetil in patients with progressive IgA nephritis. Journal of Clinical Pharmacology 2007;47(7):850‐9. [MEDLINE: ] - PubMed
    1. Keller F, Mueller L, Rasche M, Carius A, Glander P, Bauer S, et al. Pharmacokinetics and pharmacodynamics of mycophenolic acid after enteric‐coated mycophenolate sodium and mycophenolate mofetil in patients with IgA nephritis and renal impairment [abstract no: F‐PO1099]. Journal of the American Society of Nephrology 2006;17(Abstracts):568A. [CENTRAL: CN‐00615866]
Dal Canton 2005 {published data only}
    1. Dal Canton A, Amore A, Barbano G, Coppo R, Emma F, Grandaliano G, et al. One‐year angiotensin‐converting enzyme inhibition plus mycophenolate mofetil immunosuppression in the course of early IgA nephropathy: a multicenter, randomised, controlled study. Journal of Nephrology 2005;18(2):136‐40. [MEDLINE: ] - PubMed
GloMY 2010 {published data only}
    1. Harper L. Randomised pilot trial of myfortic for the treatment of primary proteinuric glomerulonephritis (Short title: proteinuria in glomerulonephritis: Myfortic (GloMY)) Trial protocol – version 3.2. www.birmingham.ac.uk/Documents/college‐mds/trials/bctu/glomy/GloMY‐proto... (accessed prior to 13 January 2020).
Imai 2006 {published data only}
    1. Imai H, Hotta O, Yoshimura M, Konta T, Tsubakihara Y, Miyazaki M, et al. Deoxyspergualin, an immunosuppressant, in patients suffering from nephropathies with crescent formation: an open‐label trial to evaluate safety and efficacy. Clinical & Experimental Nephrology 2006;10(1):40‐54. [MEDLINE: ] - PubMed
Shen 2009 {published data only}
    1. Shen SJ, Hu ZX, Wang SM, Li QH. Effects of a combined regime of Tripterygium wilfordii glycosides and benazepril in treatment of IgA nephropathy. Zhong Guo Zhong Xi Yi jie He Shen Bing Za Zhi 2009;10:154‐5. [CENTRAL: CN‐01912324]
Sulimani 2001 {published data only}
    1. Sulimani FM, Alhomssi M, Mitwalli A, al Wakeel J, Alam A, Tarif N, et al. Difficult nephropathies: a multicenter randomized trial on the treatment [abstract]. Saudi Journal of Kidney Diseases & Transplantation 2001;12(2):229. [CENTRAL: CN‐00402775]
Yonemura 2000b {published data only}
    1. Yonemura K, Kimura M, Miyaji T, Hishida A. Short‐term effect of vitamin K administration on prednisolone‐induced loss of bone mineral density in patients with chronic glomerulonephritis. Calcified Tissue International 2000;66(2):123‐8. [MEDLINE: ] - PubMed

References to studies awaiting assessment

NCT00301600 {published data only}
    1. Li LS. Mycophenolate mofetil versus intravenous cyclophosphamide pulses in the treatment of crescentic IgA nephropathy. www.clinicaltrials.gov/ct2/show/NCT00301600 (first received 13 March 2006).
NCT02160132 {published data only}
    1. Deng Y. A controlled study of steroids therapy for patients of IgA nephropathy with active pathological changes. www.ClinicalTrials.gov/show/NCT02160132 2014; Vol. (first received 10 June 2014).
NCT02571842 {published data only}
    1. Chancharoenthana W. Rituximab in recurrent IgA nephropathy. www.ClinicalTrials.gov/show/NCT02571842 (first received 8 October 2015).

References to ongoing studies

AIGA 2016 {published data only}
    1. Kim C, Lee D, Lee S, Choi B, Han S, Lee S. Efficacy and safety of a combination of mycophenolate mofetil and corticosteroid in advanced IgA nephropathy (AIGA). www.clinicalTrials.gov/show/NCT02981212 (first received 5 December 2016).
ARTEMIS‐IgAN 2018 {published data only}
    1. NCT03608033. Study of the safety and efficacy of OMS721 in patients with immunoglobulin A (IgA) nephropathy. www.clinicaltrials.gov/show/nct03608033 (first received 31 July 2018).
ChiCTR1800014442 {published data only}
    1. Li Y, Fu RG. Prospective study of the efficacy and safety of improved Italy scheme therapy for IgA nephropathy. www.chictr.org.cn/showprojen.aspx?proj=24628 (first received 13 January 2018).
MAIN 2013 {published data only}
    1. Hou F. The effects of mycophenolate mofetil (MMF) on renal outcomes in advanced immunoglobulin A (IgA) nephropathy patients. www.ClinicalTrials.gov/show/NCT01854814 (first received 16 May 2013).
NCT00657059 {published data only}
    1. Yu X, Yang Q. Mycophenolate mofetil (MMF) in patients with IgA nephropathy (IgAN). www.clinicaltrials.gov/ct2/show/NCT00657059 (first received 14 April 2008).
NCT02808429 {published data only}
    1. NCT02808429. Efficacy and safety of atacicept in IgA nephropathy. www.ClinicalTrials.gov/show/NCT02808429 (first received 21 June 2016).
NCT03468972 {published data only}
    1. Han SH. Effect of immunosuppression in IgA nephropathy. www.clinicaltrials.gov/show/nct03468972 (first received 19 March 2018).
NEFIGARD 2018 {published data only}
    1. NCT03643965. Efficacy and safety of Nefecon in patients with primary IgA (immunoglobulin A) nephropathy (Nefigard). www.clinicaltrials.gov/ct2/show/NCT03643965 (first received 23 August 2018).
PIRAT 2015 {published data only}
    1. Berthoux F. Prevention in recipients with primary IgA Nephropathy of recurrence after kidney transplantation: ATG‐F versus basiliximab as induction immunosuppressive treatment (PIRAT). www.ClinicalTrials.gov/show/NCT02523768 (first received 14 August 2015).
SIGN 2014 {published data only}
    1. Tam WK, Tumlin J, Barratt J, Rovin HB, Roberts SD, Roufosse C, et al. Spleen tyrosine kinase (SYK) inhibition in IgA nephropathy: a global, phase ii, randomised placebo‐controlled trial of fostamatinib [abstract no: SUN‐036]. Kidney International Reports 2019;4(7 Suppl):S168. [EMBASE: 2002180224]
TIGER 2017 {published data only}
    1. Joly D, Alarmartine E. Treatment of IgA nephropathy according to renal lesions (TIGER). www.ClinicalTrials.gov/show/NCT03188887 (first received 16 June 2017).
TOPplus‐IgAN 2013 {published data only}
    1. Shi W. Extended follow‐up of treatment of prednisone plus cyclophosphamide in patients with advanced‐stage IgA nephropathy (e‐TOPplus). www.ClinicalTrials.gov/show/NCT03218852 (first received 17 July 2017}.
    1. Shi W. Treatment of prednisone plus cyclophosphamide in patients with advanced‐stage IgA nephropathy (TOPplus‐IgAN). www.ClinicalTrials.gov/show/NCT01758120 (first received 1 January 2013).
UMIN000032031 {published data only}
    1. Suzuki H. The steroid internal use method for patients with IgA nephropathy. upload.umin.ac.jp/cgi‐open‐bin/ctr_e/ctr_view.cgi?recptno=R000036551 (first received 1 April 2018).

Additional references

Barbour 2019
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Berger 1968
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Coppo 2018
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Gale 2017
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