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Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00004448
Study type Interventional
Source Office of Rare Diseases (ORD)
Contact
Status Completed
Phase Phase 2
Start date November 1997

See also
  Status Clinical Trial Phase
Completed NCT01560052 - Therapeutic Evaluation of Steroids in IgA Nephropathy Global Study (TESTING Low Dose Study) N/A
Completed NCT00006137 - Pilot Study of Enalapril and Renal Function in Patients With IgA Nephropathy N/A
Completed NCT02527902 - Autonomic Nervous System (ANS) and Renal Function in Immunoglobin A (IgA) Nephropathy N/A
Completed NCT00004305 - Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis N/A
Completed NCT01115426 - Inhibitors of Angiotensin II in Proteinuric Mesangioproliferative Glomerulonephritis Phase 4