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Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)

Phase 3
Recruiting
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
Inclusion Criteria
  • 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 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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PovetaciceptPovetaciceptParticipants will be randomized to receive Povetacicept.
PlaceboPlacebo (matched to Povetacicept)Participants will be randomized to receive placebo matched to Povetacicept.
Primary Outcome Measures
NameTimeMethod
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36From Baseline at Week 36
Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104From Baseline Through Week 104
Secondary Outcome Measures
NameTimeMethod
Change From Baseline in eGFR at Week 104From Baseline at Week 104
Time to Kidney Disease Progression Through Week 104From 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 104From Baseline at Week 104

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

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Tampere University Hospital
🇫🇮Tampere, Finland

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