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

NCT06564142 · tracked via the Priya Life Science USA tracker

Sponsor

Alpine Immune Sciences Inc, A Subsidiary of Vertex

Phase

Phase 3

Started

2024-08-30

Last updated

2026-05-15

Condition(s) studied

Immunoglobulin A Nephropathy

Investigational drug(s) / intervention(s)

PovetaciceptPlacebo (matched to Povetacicept)

Povetacicept: Subcutaneous injection administration.

Placebo (matched to Povetacicept): Placebo matched to Povetacicept subcutaneous injection administration.

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Key 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.

Primary outcome measure(s)

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

Trial sites (318)

Facility	City	Region
Apogee Clinical Research, LLC	Huntsville	Alabama
Arizona Kidney Disease and Hypertension Center - Thomas Office	Phoenix	Arizona
Arizona Kidney Disease and Hypertension Center - Tuscon	Tucson	Arizona
West Coast Kidney	Fremont	California
The Medical Research Group, Inc. (FRENOVA)	Fresno	California
CARE Institute - Carabello Kidney	Los Angeles	California
Providence Medical Foundation - Orange	Orange	California
National Nephrology Alliance Research	Riverside	California
UC Davis Health	Sacramento	California
Zuckerberg San Francisco General Hospital and Trauma Center	San Francisco	California
University of California San Francisco (UCSF)	San Francisco	California
Western Nephrology	Arvada	Colorado
Colorado Kidney Care	Denver	Colorado
Nephrology Associates Delaware Kidney (FRENOVA)	Newark	Delaware
South Florida Nephrology Group PA, Research Div.	Coral Springs	Florida
Dolphin Medical Research	Doral	Florida
Nephrology Associates of Central Florida	Hollywood	Florida
Tectum Medical Research, LLC	Hollywood	Florida
South Florida Research Institute	Lauderdale Lakes	Florida
Florida Kidney Physicians - Melbourne	Melbourne	Florida
Med-Care Research	Miami	Florida
Professional Research Center	Miami	Florida
Nephrology Associates of South Miami	Miami	Florida
On Health Research Center	Miami	Florida
Combined Research Orlando Phase I-IV	Orlando	Florida
BioResearch Partner	Pembroke Pines	Florida
D&H Pompano Research Center	Pompano Beach	Florida
Cordova Research Institute, LLC	Sweetwater	Florida
SciMerge Clinical Research	Atlanta	Georgia
Georgia Nephrology - Lawrenceville	Lawrenceville	Georgia
Randomize Now - Midtown	Newnan	Georgia
Care Institute - Chubbuck, ID	Chubbuck	Idaho
Care Institute - Idaho Falls	Idaho Falls	Idaho
CARE - Boise Kidney Institute	Meridian	Idaho
Bioluminux Clinical Research	Naperville	Illinois
Rockford Nephrology Associates	Rockford	Illinois
Nephrology Associates of Northern Illinois and Indiana (NANI)	Indianapolis	Indiana
Nephrology Physicians LLC	Mishawaka	Indiana
Nephrology Associates of Kentuckiana	Louisville	Kentucky
Renal Associates of Baton Rouge	Baton Rouge	Louisiana

+ 278 more sites — see the full list on the official registry below.

Other trials for the same condition

A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy Active, not recruiting

A Study of Zigakibart in Adults With IgA Nephropathy Active, not recruiting

Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN Recruiting

Study of Sparsentan Treatment in Pediatrics With Proteinuric Glomerular Diseases Recruiting

Atrasentan in Patients With IgA Nephropathy Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06564142 on ClinicalTrials.gov ↗ ← All trials in the USA