Received September 12, 2005
Accepted on February 23, 2006

ORIGINAL ARTICLES

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

Ronald J. Hogg ^*1, Jeannette Lee , Nancy Nardelli , Bruce A. Julian , Daniel Cattran , Bryson Waldo , Robert Wyatt ^||, J. Charles Jennette ^¶, Richard Sibley ^**, Keith Hyland , Lisa Fitzgibbons , Gladys Hirschman , James V. Donadio Jr. , and Bruce J. Holub ^||||

*St. Joseph’s Hospital and Medical Center, Phoenix, Arizona; University of Alabama, Birmingham, Alabama; Medical City Dallas Hospital, Dallas, Texas; University Health Network, Toronto, Ontario, Canada; ||University of Tennessee Health Sciences Center, Memphis, Tennessee; ¶University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; **Stanford University School of Medicine, Stanford, California; Institute of Metabolic Disease, Dallas, Texas; National Institute of Diabetes and Digestive and Kidney Diseases, Division of Kidney, Urologic, and Hematologic Diseases, Bethesda, Maryland; Mayo Clinic, Rochester, Minnesota; and ||||University of Guelph, Guelph, Ontario, Canada

¹ To whom correspondence should be addressed. E-mail: spnsg{at}chw.edu.

	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 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.