Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy
Evaluate the efficacy of alternate day prednisone versus daily fish oil supplements in slowing or preventing the decline in renal function in children, adolescents, and young adults with moderate to severe immunoglobulin A nephropathy.
Drug: omega-3 fatty acids
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
|Study Start Date:||November 1997|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
PROTOCOL OUTLINE: This is randomized, double blind, placebo controlled, multicenter study.
Patients are randomized into one of three treatment arms: placebo, prednisone, or fish oil. The placebo arm is further randomized to receive either fish oil placebo capsules or prednisone placebo tablets.
Arm I: Patients receive placebo tablets or capsules for 2 years. Arm II: Patients receive a tapering regimen of prednisone tablets administered every other day for 2 years in the absence of unacceptable toxicity.
Arm III: Patients receive fish oil capsules daily for 2 years. Patients may also receive enalapril for hypertension. Patients are followed every 3 months for 3 years after treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004448
|Study Chair:||Ronald Hogg||Southwest Pediatric Nephrology Study Group|