title: Mycophenolate Mofetil Combined With Prednisone Versus Full-Dose Prednisone in IgA Nephropathy With Active Proliferative Lesions: A Randomized Controlled Trial.
abstract: BACKGROUND
  Observational studies suggest that patients with immunoglobulin A nephropathy (IgAN) with active proliferative lesions show a good response to immunosuppressive treatment.
  
  
  METHODS
  Multicenter, prospective, randomized, controlled trial.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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/1.73m2and 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.
  
  
  CONCLUSIONS
  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.affiliation: National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
authors.forename: Jin-Hua
authors.initials: JH
authors.lastname: Hou
authors.affiliation: National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
authors.forename: Wei-Bo
authors.initials: WB
authors.lastname: Le
authors.affiliation: Renal Division, Ruijin Hospital, Shanghai, China.
authors.forename: Nan
authors.initials: N
authors.lastname: Chen
authors.affiliation: Renal Division, Ruijin Hospital, Shanghai, China.
authors.forename: Wei-Ming
authors.initials: WM
authors.lastname: Wang
authors.affiliation: Renal Division, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
authors.forename: Zhang-Suo
authors.initials: ZS
authors.lastname: Liu
authors.affiliation: Renal Division, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
authors.forename: Dong
authors.initials: D
authors.lastname: Liu
authors.affiliation: Renal Division, The First Affiliated Hospital of Zhejiang University, Hangzhoua, China.
authors.forename: Jiang-Hua
authors.initials: JH
authors.lastname: Chen
authors.affiliation: Renal Division, The First Affiliated Hospital of Zhejiang University, Hangzhoua, China.
authors.forename: Jiong
authors.initials: J
authors.lastname: Tian
authors.affiliation: Renal Division, West China Hospital, Chengdu, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Fu
authors.affiliation: Renal Division, West China Hospital, Chengdu, China.
authors.forename: Zhang-Xue
authors.initials: ZX
authors.lastname: Hu
authors.affiliation: National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
authors.forename: Cai-Hong
authors.initials: CH
authors.lastname: Zeng
authors.affiliation: National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
authors.forename: Shao-Shan
authors.initials: SS
authors.lastname: Liang
authors.affiliation: National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
authors.forename: Min-Lin
authors.initials: ML
authors.lastname: Zhou
authors.affiliation: National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
authors.forename: Hai-Tao
authors.initials: HT
authors.lastname: Zhang
authors.affiliation: National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. Electronic address: liuzhihong@nju.edu.cn.
authors.forename: Zhi-Hong
authors.initials: ZH
authors.lastname: Liu
mesh_terms: D000328:Adult; D004359:Drug Therapy, Combination; D005260:Female; D005919:Glomerular Filtration Rate; D005922:Glomerulonephritis, IGA / Q000188:drug therapy* / Q000473:pathology / Q000652:urine; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D008297:Male; D009173:Mycophenolic Acid / Q000627:therapeutic use*; D011241:Prednisone / Q000008:administration & dosage* / Q000627:therapeutic use; D011507:Proteinuria / Q000652:urine; D012074:Remission Induction; D016896:Treatment Outcome
chemical_list: D005938:Glucocorticoids; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D011241:Prednisone
keywords: IgA nephropathy (IgAN); Mycophenolate mofetil (MMF); adverse event; biopsy-proven IgAN; complete remission; corticosteroid; crescents; endocapillary hypercellularity; immunosuppression; kidney disease; necrosis; prednisone; proliferative lesions; proteinuria; randomized controlled trial (RCT); renal histology; safety