Jin-Hua Hou1, Wei-Bo Le1, Nan Chen2, Wei-Ming Wang2, Zhang-Suo Liu3, Dong Liu3, Jiang-Hua Chen4, Jiong Tian4, Ping Fu5, Zhang-Xue Hu5, Cai-Hong Zeng1, Shao-Shan Liang1, Min-Lin Zhou1, Hai-Tao Zhang1, Zhi-Hong Liu6. 1. National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. 2. Renal Division, Ruijin Hospital, Shanghai, China. 3. Renal Division, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China. 4. Renal Division, The First Affiliated Hospital of Zhejiang University, Hangzhoua, China. 5. Renal Division, West China Hospital, Chengdu, China. 6. National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. Electronic address: liuzhihong@nju.edu.cn.
Abstract
BACKGROUND: Observational studies suggest that patients with immunoglobulin A nephropathy (IgAN) with active proliferative lesions show a good response to immunosuppressive treatment. STUDY DESIGN: Multicenter, prospective, randomized, controlled trial. SETTING & PARTICIPANTS: 176 patients with IgAN with active proliferative lesions (cellular and fibrocellular crescents, endocapillary hypercellularity, or necrosis), proteinuria with protein excretion ≥ 1.0g/24h, and estimated glomerular filtration rate > 30mL/min/1.73m2. INTERVENTION: Mycophenolate mofetil (MMF) group: MMF, 1.5g/d, for 6 months and prednisone, 0.4 to 0.6mg/kg/d, for 2 months and then tapered by 20% per month for the next 4 months; prednisone group: prednisone, 0.8 to 1.0mg/kg/d, for 2 months and then tapered by 20% per month for the next 4 months. All patients were followed up for another 6 months. OUTCOMES: The primary end point was complete remission rate at 6 and 12 months. RESULTS: At baseline, median estimated glomerular filtration rates were 90.2 and 94.3mL/min/1.73m2 and mean proteinuria was protein excretion of 2.37 and 2.47g/24h in the MMF and prednisone groups, respectively. At 6 months, complete remission rates were 37% (32 of 86 patients) and 38% (33 of 88 patients); the between-group difference was not statistically significant (P=0.9). At 12 months, complete remission rates were 48% (35 of 73 patients) and 53% (38 of 72 patients) in the MMF and prednisone groups, respectively; the between-group difference was not statistically significant (P=0.6). Incidences of Cushing syndrome and newly diagnosed diabetes mellitus were lower in the MMF group than in the prednisone group. LIMITATIONS: Not all participants were treated with renin-angiotensin system blockers, relatively short follow-up. CONCLUSIONS:MMF plus prednisone versus full-dose prednisone did not differ in reducing proteinuria, but patients treated with the former had fewer adverse events in patients with IgAN with active proliferative lesions.
RCT Entities:
BACKGROUND: Observational studies suggest that patients with immunoglobulin A nephropathy (IgAN) with active proliferative lesions show a good response to immunosuppressive treatment. STUDY DESIGN: Multicenter, prospective, randomized, controlled trial. SETTING & PARTICIPANTS: 176 patients with IgAN with active proliferative lesions (cellular and fibrocellular crescents, endocapillary hypercellularity, or necrosis), proteinuria with protein excretion ≥ 1.0g/24h, and estimated glomerular filtration rate > 30mL/min/1.73m2. INTERVENTION: Mycophenolate mofetil (MMF) group: MMF, 1.5g/d, for 6 months and prednisone, 0.4 to 0.6mg/kg/d, for 2 months and then tapered by 20% per month for the next 4 months; prednisone group: prednisone, 0.8 to 1.0mg/kg/d, for 2 months and then tapered by 20% per month for the next 4 months. All patients were followed up for another 6 months. OUTCOMES: The primary end point was complete remission rate at 6 and 12 months. RESULTS: At baseline, median estimated glomerular filtration rates were 90.2 and 94.3mL/min/1.73m2 and mean proteinuria was protein excretion of 2.37 and 2.47g/24h in the MMF and prednisone groups, respectively. At 6 months, complete remission rates were 37% (32 of 86 patients) and 38% (33 of 88 patients); the between-group difference was not statistically significant (P=0.9). At 12 months, complete remission rates were 48% (35 of 73 patients) and 53% (38 of 72 patients) in the MMF and prednisone groups, respectively; the between-group difference was not statistically significant (P=0.6). Incidences of Cushing syndrome and newly diagnosed diabetes mellitus were lower in the MMF group than in the prednisone group. LIMITATIONS: Not all participants were treated with renin-angiotensin system blockers, relatively short follow-up. CONCLUSIONS:MMF plus prednisone versus full-dose prednisone did not differ in reducing proteinuria, but patients treated with the former had fewer adverse events in patients with IgAN with active proliferative lesions.
Authors: Aliza Thompson; Kevin Carroll; Lesley A Inker; Jürgen Floege; Vlado Perkovic; Sonia Boyer-Suavet; Rupert W Major; Judith I Schimpf; Jonathan Barratt; Daniel C Cattran; Barbara S Gillespie; Annamaria Kausz; Alex W Mercer; Heather N Reich; Brad H Rovin; Melissa West; Patrick H Nachman Journal: Clin J Am Soc Nephrol Date: 2019-01-11 Impact factor: 8.237
Authors: Thomas Rauen; Christina Fitzner; Frank Eitner; Claudia Sommerer; Martin Zeier; Britta Otte; Ulf Panzer; Harm Peters; Urs Benck; Peter R Mertens; Uwe Kuhlmann; Oliver Witzke; Oliver Gross; Volker Vielhauer; Johannes F E Mann; Ralf-Dieter Hilgers; Jürgen Floege Journal: J Am Soc Nephrol Date: 2017-10-17 Impact factor: 10.121