Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)
- Conditions
- Immunoglobulin A Nephropathy
- Interventions
- Drug: Placebo (matched to Povetacicept)
- Registration Number
- NCT06564142
- Lead Sponsor
- Alpine Immune Sciences Inc, A Subsidiary of Vertex
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 480
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Povetacicept Povetacicept Participants will be randomized to receive Povetacicept. Placebo Placebo (matched to Povetacicept) Participants will be randomized to receive placebo matched to Povetacicept.
- Primary Outcome Measures
Name Time Method Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 From Baseline at Week 36 Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104 From Baseline Through Week 104
- Secondary Outcome Measures
Name Time Method Change From Baseline in eGFR at Week 104 From Baseline at Week 104 Time to Kidney Disease Progression Through Week 104 From Baseline Through Week 104 Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or death from kidney failure.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score at Week 104 From Baseline at Week 104
Related Research Topics
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Trial Locations
- Locations (301)
Tampere University Hospital
🇫🇮Tampere, Finland
Klinikum St Georg
🇩🇪Leipzig, Germany
Azienda Ospedaliera Universitaria Consorziale - policlinicio Bari
🇮🇹Bari, Italy
AOU Policlinico di Modena
🇮🇹Modena, Italy
Apogee Clinical Research, LLC
🇺🇸Huntsville, Alabama, United States
Arizona Kidney Disease and Hypertension Center - Thomas Office
🇺🇸Phoenix, Arizona, United States
Arizona Kidney Disease and Hypertension Center - Tuscon
🇺🇸Tucson, Arizona, United States
West Coast Kidney
🇺🇸Fremont, California, United States
The Medical Research Group, Inc. (FRENOVA)
🇺🇸Fresno, California, United States
CARE Institute - Carabello Kidney
🇺🇸Los Angeles, California, United States
Scroll for more (291 remaining)Tampere University Hospital🇫🇮Tampere, Finland