drugset / Trial / NCT01854814
The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is to evaluate the effect of Mycophenolate Mofetil compared with losartan alone on time to doubling of serum creatinine or the onset of end stage renal disease in patients with advanced IgA nephropathy who are treated with the maximal tolerated daily dose of losartan.The study will also assess the effects of MMF compared with losartan alone on the changes of urine albumin excretion and the changes in estimated glomerular filtration rate.
Timeline
- Start
- 2013-07
- Primary completion
- 2022-02
- Completion
- 2022-05
Outcome
Met primary endpoint
paper Primary composite outcome events occurred in 6 patients (7.1%) in the MMF group and 18 patients (21.2%) in the SC group PMID 36745456 ↗
paper adjusted hazard ratio [aHR], 0.23; 95% CI, 0.09-0.63 PMID 36745456 ↗
Publications
- Background Tang SC, Tang AW, Wong SS, Leung JC, Ho YW, Lai KN. Long-term study of mycophenolate mofetil treatment in IgA nephropathy. Kidney Int. 2010 Mar;77(6):543-9. doi: 10.1038/ki.2009.499. Epub 2009 Dec 23.
- Background Frisch G, Lin J, Rosenstock J, Markowitz G, D'Agati V, Radhakrishnan J, Preddie D, Crew J, Valeri A, Appel G. Mycophenolate mofetil (MMF) vs placebo in patients with moderately advanced IgA nephropathy: a double-blind randomized controlled trial. Nephrol Dial Transplant. 2005 Oct;20(10):2139-45. doi: 10.1093/ndt/gfh974. Epub 2005 Jul 19.
- Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2.
- Hou FF, Xie D, Wang J, Xu X, Yang X, Ai J, Nie S, Liang M, Wang G, Jia N; MAIN Trial Investigators. Effectiveness of Mycophenolate Mofetil Among Patients With Progressive IgA Nephropathy: A Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2254054. doi: 10.1001/jamanetworkopen.2022.54054.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 1.5 g | — |
| Comparator | Losartan | Other / unclassified | — | — |