A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)

Description

The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.

Trial Eligibility

Key Inclusion Criteria: * Diagnosed IgAN, with biopsy confirmation within 10 years of screening * 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2 * Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification Key Exclusion Criteria: * Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol * Rapidly progressive glomerulonephritis with eGFR reduction \>50% within 12 weeks of the start of screening Other protocol defined Inclusion/Exclusion criteria may apply.

Study Info

Interventions

Locations Recruiting

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