Actively Recruiting
Phase 2 Trial of Avacopan with Low-Dose Glucocorticoids for Treating Crescentic IgA Nephropathy
Led by Mayo Clinic · Updated on 2025-10-03
16
Participants Needed
2
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Avacopan combined with low-dose glucocorticoids for treating patients with crescentic Immunoglobulin A Nephropathy IgAN who are at high risk of disease progression. This Phase II, multi-center, open-label, randomized trial aims to compare Avacopan plus low-dose steroids against a higher-dose steroid regimen to understand their impact on kidney function in this patient group. Participants will be assigned to one of two treatment groups. One group will receive Avacopan orally twice daily along with low-dose prednisone tapered over 6 to 9 months, plus an intravenous dose of methylprednisolone on day 1. The other group will receive higher doses of prednisone tapered over the same period, also with intravenous methylprednisolone on day 1. Treatment duration for Avacopan is 12 months, while glucocorticoid treatment lasts between 6 and 9 months. During the study, participants will undergo regular assessments including 24-hour urine collections to measure protein levels, kidney function tests eGFR, and evaluations of blood in the urine. These measures will be taken at baseline, 6 months, and 12 months to monitor treatment effects. The primary outcome focuses on changes in proteinuria after 12 months. The total study period extends up to 12 months with ongoing safety monitoring and data collection throughout.
CONDITIONS
Brief Title
Avacopan in Crescentic Immunoglobulin A Nephropathy (IgAN)
Research Team
C
Corbyn Bendtsen
Z
Zach Monson
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