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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Collaborator: Southwest Pediatric Nephrology Study Group
• Treatments: Prednisone

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically confirmed immunoglobulin A nephropathy (IgAN) Patients must have either: - Persistent severe proteinuria alone (urine Pr/Cr ratio at least 1.0) OR - Moderate proteinuria plus renal biopsy changes indicating risk of progression (glomerulosclerosis or proliferation) --Prior/Concurrent Therapy-- Endocrine therapy: At least 1 month since any prior prednisone No more than 3 months of prior prednisone therapy since renal biopsy Other: At least 1 month since any prior immunosuppressive therapy or fish oils No more than 3 months of prior immunosuppressive therapy or fish oil administration since renal biopsy --Patient Characteristics-- Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 2 times ULN No known chronic liver disease Renal: Protein excretion greater than 0.5 g/1.73 m2/24 hours OR Urine protein/creatinine ratio greater than 0.5 on 2 occasions at least 4 weeks apart in the 6 months prior to study Creatinine clearance at least 50 mL/min Other: No systemic lupus erythematosus No Henoch-Schonlein purpura No diabetes mellitus, cataracts, aseptic necrosis of any bone, or other conditions potentially exacerbated by prednisone therapy Not pregnant Adequate contraception required of all fertile patients