Status:
ACTIVE_NOT_RECRUITING
Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
Lead Sponsor:
Alpine Immune Sciences Inc, A Subsidiary of Vertex
Conditions:
Immunoglobulin A Nephropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Key
- Diagnosed IgAN, with biopsy confirmation
- 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
- 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.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2028
Estimated Enrollment :
605 Patients enrolled
Trial Details
Trial ID
NCT06564142
Start Date
August 30 2024
End Date
January 30 2028
Last Update
December 17 2025
Active Locations (318)
Enter a location and click search to find clinical trials sorted by distance.
1
Apogee Clinical Research, LLC
Huntsville, Alabama, United States, 35805
2
Arizona Kidney Disease and Hypertension Center - Thomas Office
Phoenix, Arizona, United States, 85016
3
Arizona Kidney Disease and Hypertension Center - Tuscon
Tucson, Arizona, United States, 85741
4
West Coast Kidney
Fremont, California, United States, 94538