title: Long-term results of a randomized controlled trial in childhood IgA nephropathy.
abstract: OBJECTIVE
  Children with IgA nephropathy showing diffuse (>80%) mesangial proliferation are at high risk for end-stage renal failure (ESRF). A previous controlled trial showed that combination therapy consisting of prednisolone, azathioprine, heparin-warfarin, and dipyridamole early in the course of disease reduces immunologic renal injury and prevents the progression of sclerosed glomeruli. The objective of this study was to evaluate the long-term effectiveness of combination therapy in children with IgA nephropathy showing diffuse mesangial proliferation.
  
  
  METHODS
  A secondary analysis of a multicenter, randomized, controlled trial involving 78 children with IgA nephropathy who received either 2-year combination therapy or heparin-warfarin and dipyridamole (control) therapy was conducted.
  
  
  RESULTS
  The median duration of observation was 10 years (range, 0.5 to 18). Two of 40 patients (5%) who received combination therapy and five of 34 patients (14.7%) who received control therapy developed ESRF. A Kaplan-Meier plot of renal survival showed that the outcomes of patients in the combined therapy group were better than those in the control therapy group (log-rank P = 0.03). The 10-year renal survival probability of each group was 97.1% (95% confidence interval, 81.4 to 99.6%) and 84.8% (95% confidence interval, 55.4 to 95.5%), respectively. The Cox proportional hazards model showed that the 2-year combination therapy was significantly associated with renal survival in both univariate and multivariate analyses.
  
  
  CONCLUSIONS
  Two-year combination therapy not only ameliorated the activity of the acute phase of nephritis but also improved the long-term outcome of severe childhood IgA nephropathy.
authors.affiliation: Department of Nephrology, National Center for Child Health and Development, Setagaya, Tokyo, Japan.
authors.forename: Koichi
authors.initials: K
authors.lastname: Kamei
authors.forename: Koichi
authors.initials: K
authors.lastname: Nakanishi
authors.forename: Shuichi
authors.initials: S
authors.lastname: Ito
authors.forename: Mari
authors.initials: M
authors.lastname: Saito
authors.forename: Mayumi
authors.initials: M
authors.lastname: Sako
authors.forename: Kenji
authors.initials: K
authors.lastname: Ishikura
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hataya
authors.forename: Masataka
authors.initials: M
authors.lastname: Honda
authors.forename: Kazumoto
authors.initials: K
authors.lastname: Iijima
authors.forename: Norishige
authors.initials: N
authors.lastname: Yoshikawa
mesh_terms: D000293:Adolescent; D000925:Anticoagulants / Q000627:therapeutic use*; D001379:Azathioprine / Q000627:therapeutic use*; D049109:Cell Proliferation / Q000187:drug effects; D002648:Child; D004176:Dipyridamole / Q000627:therapeutic use*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D005260:Female; D005922:Glomerulonephritis, IGA / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007564:Japan; D053208:Kaplan-Meier Estimate; D007676:Kidney Failure, Chronic / Q000209:etiology / Q000517:prevention & control*; D007678:Kidney Glomerulus / Q000187:drug effects / Q000473:pathology; D008297:Male; D011239:Prednisolone / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011507:Proteinuria / Q000188:drug therapy / Q000209:etiology; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014859:Warfarin / Q000627:therapeutic use*
chemical_list: D000925:Anticoagulants; D007166:Immunosuppressive Agents; D014859:Warfarin; D004176:Dipyridamole; D006493:Heparin; D011239:Prednisolone; D001379:Azathioprine