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

Phase 3

Recruiting

• Conditions: Immunoglobulin A Nephropathy
• Interventions: Drug: Povetacicept; 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-21
• Study Start: 2024-08-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2028-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

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

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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.

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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

Trial Locations

Locations (31)

DaVita Clinical Research Nevada - Las Vegas; 🇺🇸 Las Vegas, Nevada, United States

Kidney and Hypertension Specialist PLLC; 🇺🇸 Manassas, Virginia, United States

St Pancras Clinical Research; 🇬🇧 London, United Kingdom

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

Western Nephrology; 🇺🇸 Arvada, Colorado, United States

CARE Institute - Carabello Kidney; 🇺🇸 Los Angeles, California, United States

South Florida Nephrology Group PA, Research Div.; 🇺🇸 Coral Springs, Florida, United States

Nephrology Associates of Central Florida; 🇺🇸 Hollywood, Florida, United States

Tectum Medical Research, LLC; 🇺🇸 Hollywood, Florida, United States

Florida Kidney Physicians - Melbourne; 🇺🇸 Melbourne, Florida, United States

SciMerge Clinical Research; 🇺🇸 Atlanta, Georgia, United States

Georgia Nephrology - Lawrenceville; 🇺🇸 Lawrenceville, Georgia, United States

Care Institute - Chubbuck, ID; 🇺🇸 Chubbuck, Idaho, United States

Care Institute - Idaho Falls; 🇺🇸 Idaho Falls, Idaho, United States

CARE - Boise Kidney Institute; 🇺🇸 Meridian, Idaho, United States

Rockford Nephrology Associates; 🇺🇸 Rockford, Illinois, United States

Velocity Clinical Research - Metairie; 🇺🇸 Metairie, Louisiana, United States

InterMed Consultants / DaVita Clinical Research, Edina; 🇺🇸 Edina, Minnesota, United States

New York Nephrology Vasculitis and Glomerular Center; 🇺🇸 Albany, New York, United States

Metrolina Nephrology Associates; 🇺🇸 Charlotte, North Carolina, United States

Nephrology Associates Inc; 🇺🇸 East Providence, Rhode Island, United States

South Carolina Clinical Research, LLC; 🇺🇸 Orangeburg, South Carolina, United States

Prolato Clinical Research Center; 🇺🇸 Houston, Texas, United States

R & H Clinical Research; 🇺🇸 Katy, Texas, United States

North Texas Kidney Disease Associates; 🇺🇸 Lewisville, Texas, United States

P&I Clinical Research, LLC; 🇺🇸 Lufkin, Texas, United States

Renal Specialists of Houston; 🇺🇸 Pasadena, Texas, United States

Utah Kidney Research Institute; 🇺🇸 Salt Lake City, Utah, United States

Prince Wales Hospital; 🇭🇰 Shatin, Hong Kong