IGA Glomerulonephritis Clinical Trial
OBJECTIVES:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
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