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Prednisone vs Fish Oil in IgA Nephropathy
NCT00004448Phase 2
Key facts
- Status
- Completed
- Start
- Nov 1997
- Primary completion
- Aug 2007
- Countries
- 1
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases
- Modality
- Orthosteric Ligands
- Conditions
- IgA nephropathy (IgAN)
01
Overview
Phase 2, randomised, double-blind trial in IgA nephropathy (IgAN) comparing Placebo, Prednisone and Omega-3 fatty acids (3 arms). Primary endpoint: Time to failure up to 5 years. Started Nov 1997; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Placebo
Placebo tablets or capsules
Prednisone
Tapering regimen of alternate-day prednisone
Omega-3 fatty acids
Daily fish oil capsules
03
Who it enrols
Patients with histologically confirmed IgA nephropathy, moderate to severe proteinuria (urine Pr/Cr ratio >= 1.0 or >= 0.5 with biopsy risk factors), and creatinine clearance >= 50 mL/min. Excludes patients with SLE, Henoch-Schonlein purpura, diabetes, or recent prior prednisone/immunosuppressive therapy.
04
Endpoints
Primary
Time to failure
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