title: 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.
abstract: This randomized, placebo-controlled, double-blind trial evaluated the role of prednisone and omega 3 fatty acids (O3FA) in patients with IgA nephropathy. Entry criteria were (1) biopsy-proven IgA nephropathy, (2) estimated GFR > or = 50 ml/min per 1.73 m2, and (3) moderate to severe proteinuria. Thirty-three patients were randomly assigned to receive prednisone 60 mg/m2 every other day for 3 mo, then 40 mg/m2 every other day for 9 mo, then 30 mg/m2 every other day for 12 mo (prednisone group); 32 were randomly assigned to receive O3FA 4 g/d for 2 yr (1.88 g eicosapentaenoic acid, 1.48 g docosahexaenoic acid; O3FA group); and 31 were randomly assigned to receive placebo (placebo group). Most (73%) patients completed 2 yr of treatment. Randomly assigned patients who were hypertensive were given enalapril 2.5 to 40 mg/d. The primary end point was time to failure, defined as estimated GFR <60% of baseline. An overall significance level of 0.10 was used. The three groups were comparable at baseline except that the O3FA group had higher urine protein to creatinine (UP/C) ratios than the placebo group (P = 0.003). Neither treatment group showed benefit over the placebo group with respect to time to failure, with 14 patient failures overall (two in the prednisone group, eight in the O3FA group, and four in the placebo group). The primary factor associated with time to failure was higher baseline UP/C ratios (P = 0.009). Superiority of prednisone or O3FA over placebo in slowing progression of renal disease was not demonstrated in this study. However, the relatively short follow-up period, inequality of baseline UP/C ratios, and small numbers of patients precludes definitive conclusions.
authors: St. Joseph's Hospital and Medical Center, 222 W. Thomas Road, Suite 410, Phoenix, AZ, USA. spnsg@chw.edu
authors: Ronald J
authors: RJ
authors: Hogg
authors: Jeannette
authors: J
authors: Lee
authors: Nancy
authors: N
authors: Nardelli
authors: Bruce A
authors: BA
authors: Julian
authors: Daniel
authors: D
authors: Cattran
authors: Bryson
authors: B
authors: Waldo
authors: Robert
authors: R
authors: Wyatt
authors: J Charles
authors: JC
authors: Jennette
authors: Richard
authors: R
authors: Sibley
authors: Keith
authors: K
authors: Hyland
authors: Lisa
authors: L
authors: Fitzgibbons
authors: Gladys
authors: G
authors: Hirschman
authors: James V
authors: JV
authors: Donadio
authors: Bruce J
authors: BJ
authors: Holub
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D015525:Fatty Acids, Omega-3 / Q000627:therapeutic use*; D005260:Female; D005922:Glomerulonephritis, IGA / Q000188:drug therapy*; D005938:Glucocorticoids / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D011241:Prednisone / Q000008:administration & dosage*
chemical_list: D015525:Fatty Acids, Omega-3; D005938:Glucocorticoids; D011241:Prednisone