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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Povetacicept 		Participants will be randomized to receive Povetacicept.
  • Drug: Povetacicept
    Subcutaneous injection administration.
    Other names:
    • ALPN-303
Placebo Comparator
Placebo 		Participants will be randomized to receive placebo matched to Povetacicept.
  • Drug: Placebo (matched to Povetacicept)
    Placebo matched to Povetacicept subcutaneous injection administration.

Recruiting Locations

Apogee Clinical Research, LLC
Huntsville, Alabama 35805

Arizona Kidney Disease and Hypertension Center - Thomas Office
Phoenix, Arizona 85016

Arizona Kidney Disease and Hypertension Center - Tuscon
Tucson, Arizona 85741

West Coast Kidney
Fremont, California 94538

CARE Institute - Carabello Kidney
Los Angeles, California 90022

Providence Medical Foundation - Orange
Orange, California 92868

Western Nephrology
Arvada, Colorado 80002

Colorado Kidney Care
Denver, Colorado 80230

Nephrology Associates Delaware Kidney
Newark, Delaware 19713

South Florida Nephrology Group PA, Research Div.
Coral Springs, Florida 33071

Dolphin Medical Research
Doral, Florida 33172

Nephrology Associates of Central Florida
Hollywood, Florida 32806

Tectum Medical Research, LLC
Hollywood, Florida 33024

South Florida Research Institute
Lauderdale Lakes, Florida 33313

Florida Kidney Physicians - Melbourne
Melbourne, Florida 32901

Med-Care Research
Miami, Florida 33125

Professional Research Center
Miami, Florida 33172

Nephrology Associates of South Miami
Miami, Florida 33173

On Health Research Center
Miami, Florida 33186

Combined Research Orlando Phase I-IV
Orlando, Florida 32807

BioResearch Partner
Pembroke Pines, Florida 33029

D&H Pompano Research Center
Pompano Beach, Florida 33064

Cordova Research Institute, LLC
Sweetwater, Florida 33182

SciMerge Clinical Research
Atlanta, Georgia 30274

Georgia Nephrology - Lawrenceville
Lawrenceville, Georgia 30046

Randomize Now - Midtown
Newnan, Georgia 30269

Care Institute - Chubbuck, ID
Chubbuck, Idaho 83202

Care Institute - Idaho Falls
Idaho Falls, Idaho 83404

CARE - Boise Kidney Institute
Meridian, Idaho 83642

Bioluminux Clinical Research
Naperville, Illinois 60540

Rockford Nephrology Associates
Rockford, Illinois 61107

Nephrology Associates of Northern Illinois and Indiana (NANI)
Indianapolis, Indiana 46227

Nephrology Physicians LLC
Mishawaka, Indiana 46545

Nephrology Associates of Kentuckiana
Louisville, Kentucky 40205

Renal Associates of Baton Rouge
Baton Rouge, Louisiana 70808

Velocity Clinical Research - Metairie
Metairie, Louisiana 70006

St. Clair Nephrology Research
Shelby, Michigan 48315

InterMed Consultants / DaVita Clinical Research, Edina
Edina, Minnesota 55404

Mayo Clinic - Rochester
Rochester, Minnesota 55905

Nephrology and Hypertension Associates, LTD
Tupelo, Mississippi 38801

Somnos Clinical Research
Lincoln, Nebraska 68505

DaVita Clinical Research Nevada - Las Vegas
Las Vegas, Nevada 89129

Bioluminux Clinical Research New Jersey
Hamilton, New Jersey 08690

New Jersey Kidney Care, LLC (FRENOVA)
Jersey City, New Jersey 07305

Renal Medicine Associates
Albuquerque, New Mexico 87109

New York Nephrology Vasculitis and Glomerular Center
Albany, New York 12209

Queens Hospital Center
Jamaica, New York 11432

Metrolina Nephrology Associates
Charlotte, North Carolina 28208

Nephrology Associates Inc
East Providence, Rhode Island 02914

Hypertension & Nephrology Inc.
Providence, Rhode Island 02904

South Carolina Clinical Research, LLC
Orangeburg, South Carolina 29118

Knoxville Kidney Center (KKC), PLLC
Knoxville, Tennessee 37923

Velocity Clinical Research
Abilene, Texas 79606

Introscience Research LLC
Bellaire, Texas 77401

Dallas Renal Group
Dallas, Texas 75230

Renal Disease Research Institute - Dallas
Dallas, Texas 75264

Davita Clinical Research - El Paso
El Paso, Texas 79925

Prolato Clinical Research Center
Houston, Texas 77054

Houston Medical Research Institute, LLC (FRENOVA)
Houston, Texas 77074

R & H Clinical Research
Katy, Texas 77450

North Texas Kidney Disease Associates
Lewisville, Texas 75057

P&I Clinical Research, LLC
Lufkin, Texas 75904

Renal Specialists of Houston
Pasadena, Texas 77504

Utah Kidney Research Institute
Salt Lake City, Utah 84115

University of Vermont
Burlington, Vermont 05401

Virginia Nephrology Group
Fairfax, Virginia 22101

Kidney and Hypertension Specialist PLLC
Manassas, Virginia 20110

More Details

NCT ID
NCT06564142
Status
Recruiting
Sponsor
Alpine Immune Sciences Inc, A Subsidiary of Vertex

Study Contact

Medical Information
617-341-6777
medicalinfo@vrtx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center