Alternate Day Prednisone or Daily Fish Oil Supplements in Patients With Immunoglobulin A Nephropathy

Phase 2

Completed

• Conditions: IgA Glomerulonephritis
• Interventions: Drug: prednisone; Drug: omega-3 fatty acids; Drug: Placebo

• Registration Number: NCT00004448
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1997-11
• Study First Submitted: 1999-10-18
• Study First Submitted QC: 1999-10-18
• Study First Posted: 1999-10-19
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2008-09
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone	prednisone	Tapering regimen of alternate-day prednisone tablets (Deltasone)
omega-3 fatty acids	omega-3 fatty acids	Omega 3 fatty acid Omacor
Placebo	Placebo	Placebo for prednisone or fatty acid

Primary Outcome Measures

Name	Time	Method
Time to failure	Up to 5 years after randomization	Time to failure was defined as the interval until the eGFR fell to \<60% of baseline value.

Trial Locations

Locations (1)

Medical City Dallas Hospital; 🇺🇸 Dallas, Texas, United States