Document Detail


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.
MedLine Citation:
PMID:  17699247     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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:
Ronald J Hogg; 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; Bruce J Holub;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural     Date:  2006-04-12
Journal Detail:
Title:  Clinical journal of the American Society of Nephrology : CJASN     Volume:  1     ISSN:  1555-905X     ISO Abbreviation:  -     Publication Date:  2006 May 
Date Detail:
Created Date:  2007-08-16     Completed Date:  2007-09-25     Revised Date:  2007-12-03    
Medline Journal Info:
Nlm Unique ID:  101271570     Medline TA:  Clin J Am Soc Nephrol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  467-74     Citation Subset:  IM    
Affiliation:
St. Joseph's Hospital and Medical Center, 222 W. Thomas Road, Suite 410, Phoenix, AZ, USA. spnsg@chw.edu
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MeSH Terms
Descriptor/Qualifier:
Adult
Double-Blind Method
Drug Administration Schedule
Drug Therapy, Combination
Fatty Acids, Omega-3 / therapeutic use*
Female
Glomerulonephritis, IGA / drug therapy*
Glucocorticoids / administration & dosage*
Humans
Male
Prednisone / administration & dosage*
Grant Support
ID/Acronym/Agency:
R01 DK49368/DK/NIDDK NIH HHS
Chemical
Reg. No./Substance:
0/Fatty Acids, Omega-3; 0/Glucocorticoids; 53-03-2/Prednisone
Comments/Corrections
Comment In:
Clin J Am Soc Nephrol. 2006 May;1(3):347-8   [PMID:  17699228 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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