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

Last updated: April 3, 2025
Sponsor: Alpine Immune Sciences Inc, A Subsidiary of Vertex
Overall Status: Active - Recruiting

Phase

3

Condition

Glomerulonephritis

Treatment

Povetacicept

Placebo (matched to Povetacicept)

Clinical Study ID

NCT06564142
VX24-AIS-D08
EU CT number
2024-514135-17-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 receptorblocker (ARBs) as per protocol specification

Exclusion

Key Exclusion Criteria:

  • Have received any immunosuppressive treatment or procedures (includingcorticosteroids, oral immunosuppressive agents, B cell or plasma cell targetedtherapies, complement targeted therapies, herbal medicines per protocol, andtonsillectomy) within a wash-out period per protocol

  • Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks ofthe start of screening

Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 480
Treatment Group(s): 2
Primary Treatment: Povetacicept
Phase: 3
Study Start date:
August 30, 2024
Estimated Completion Date:
September 30, 2028

Connect with a study center

  • Grampians Health Ballarat

    Ballarat,
    Australia

    Active - Recruiting

  • Bendigo Hospital

    Bendigo,
    Australia

    Active - Recruiting

  • Core Research Group Pty Ltd

    Brisbane,
    Australia

    Active - Recruiting

  • Royal Prince Alfred Hospital

    Camperdown,
    Australia

    Active - Recruiting

  • Monash Health

    Clayton,
    Australia

    Active - Recruiting

  • Concord Repatriation General Hospital

    Concord,
    Australia

    Active - Recruiting

  • Renal Research Gosford

    Gosford,
    Australia

    Active - Recruiting

  • Austin Hospital

    Heidelberg,
    Australia

    Active - Recruiting

  • Fiona Stanley Hospital

    Murdoch,
    Australia

    Active - Recruiting

  • John Hunter Hospital

    Newcastle,
    Australia

    Active - Recruiting

  • Melbourne Renal Research

    Reservoir,
    Australia

    Active - Recruiting

  • Klinikum Wels- Grieskirchen

    Wels-Grieskirchen,
    Austria

    Active - Recruiting

  • St. Josephs Healthcare - Hamilton

    Hamilton,
    Canada

    Active - Recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing,
    China

    Active - Recruiting

  • Peking University First Hos

    Beijing,
    China

    Active - Recruiting

  • The Second Norman Bethune Hospital of Jilin University

    Changchun,
    China

    Active - Recruiting

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi,
    China

    Active - Recruiting

  • Sichuan People s Hospital

    Chengdu,
    China

    Active - Recruiting

  • Bishan Hospital of Chongqing

    Chongqing,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing,
    China

    Active - Recruiting

  • Dongguan People s Hospital

    Dongguan,
    China

    Active - Recruiting

  • Fuyang People's Hospital

    Fuyang City,
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou,
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou,
    China

    Active - Recruiting

  • Third Affiliated Hospital of Southern Medical University

    Guangzhou,
    China

    Active - Recruiting

  • Zhujiang Hospital, Southern Medical University

    Guangzhou,
    China

    Active - Recruiting

  • Affiliated Hospital of Guilin Medical University

    Guilin,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei,
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)

    Jinan,
    China

    Active - Recruiting

  • The Second Hospital of Shandong University

    Jinan,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang,
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong City,
    China

    Active - Recruiting

  • Ningbo No.2 Hospital

    Ningbo,
    China

    Active - Recruiting

  • The First Affiliated Hospital of Ningbo University

    Ningbo,
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang,
    China

    Active - Recruiting

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen,
    China

    Active - Recruiting

  • The Second Hospital of Hebei Medical University

    Shijiazhuang,
    China

    Active - Recruiting

  • Taian City Central Hospital

    Taian,
    China

    Active - Recruiting

  • Wuxi People s Hospital

    Wuxi,
    China

    Active - Recruiting

  • Xuancheng People s Hospital

    Xuancheng,
    China

    Active - Recruiting

  • Affiliated Hospital Yangzhou University

    Yangzhou City,
    China

    Active - Recruiting

  • Yantai YuHuangDing Hospital

    Yantai,
    China

    Active - Recruiting

  • Yichang central people Hos

    Yichang,
    China

    Active - Recruiting

  • Nemocnice AGEL Novy Jicin a.s.

    Nový Jičín,
    Czechia

    Active - Recruiting

  • Aalborg University Hospital

    Aalborg,
    Denmark

    Active - Recruiting

  • Center for Cancer and Organ Diseases - Rigshospitalet - Hornum Mads

    Copenhagen,
    Denmark

    Active - Recruiting

  • North Estonia Medical Centre Foundation

    Tallin,
    Estonia

    Active - Recruiting

  • Tartu University Hospital

    Tartu,
    Estonia

    Active - Recruiting

  • Groupe Hospitalier Pellegrin, CHU De Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • Hopitaux Universitaires Henri Mondor

    Creteil,
    France

    Active - Recruiting

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay,
    France

    Active - Recruiting

  • AP-HM - Hopital de La Conception

    Marseille,
    France

    Active - Recruiting

  • CHU de Nantes - Hotel-Dieu

    Nantes,
    France

    Active - Recruiting

  • Hopital Necker - Enfants Malades

    Paris,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord

    St Priest en Jarez,
    France

    Active - Recruiting

  • Centre Hospitalier de Valencienes

    Valenciennes,
    France

    Active - Recruiting

  • Charite Universitaetsnedizin Berlin

    Berlin,
    Germany

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Prince Wales Hospital

    Shatin,
    Hong Kong

    Active - Recruiting

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pecs,
    Hungary

    Active - Recruiting

  • Barzilai Medical Center

    Ashkelon,
    Israel

    Active - Recruiting

  • Sheba Medical Center

    Tel Hashomer,
    Israel

    Active - Recruiting

  • Shamir Medical Center

    Zerifin,
    Israel

    Active - Recruiting

  • Istituti Clinici Scientifici Maugeri-IRCCS Pavia

    Pavia,
    Italy

    Active - Recruiting

  • Fujita Health University Hos

    Aichi,
    Japan

    Active - Recruiting

  • Hyogo Amagasaki Gen Med Ctr

    Amagasaki,
    Japan

    Active - Recruiting

  • Fukuoka University Hospital

    Fukuoka,
    Japan

    Active - Recruiting

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka,
    Japan

    Active - Recruiting

  • Kanazawa Medical Uni Hospital

    Kahoku,
    Japan

    Active - Recruiting

  • Kanazawa University Hospital

    Kanazawa,
    Japan

    Active - Recruiting

  • Nara Med University Hos

    Kashihara,
    Japan

    Active - Recruiting

  • Kasugai Municipal Hospital

    Kasugai,
    Japan

    Active - Recruiting

  • Okayama University Hospital

    Kita-ku,
    Japan

    Active - Recruiting

  • Kokura Memorial Hospital

    Kitakyushu-shi,
    Japan

    Active - Recruiting

  • Kobe University Hospital

    Kobe,
    Japan

    Active - Recruiting

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya,
    Japan

    Active - Recruiting

  • Kyoto University Hospital

    Kyoto,
    Japan

    Active - Recruiting

  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto-shi,
    Japan

    Active - Recruiting

  • University of Miyazaki Hos

    Miyazaki,
    Japan

    Active - Recruiting

  • Osaka City General Hospital

    Osaka,
    Japan

    Active - Recruiting

  • Osaka General Medical Center

    Osaka,
    Japan

    Active - Recruiting

  • Sapporo City General Hospital

    Sapporo-shi,
    Japan

    Active - Recruiting

  • Tohoku University Tohoku University Hospital

    Sendai-shi,
    Japan

    Active - Recruiting

  • Juntendo Hospital Affiliated to Juntendo University School of Medicine

    Tokyo,
    Japan

    Active - Recruiting

  • The Jikei Uni Daisan Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • The Jikei University Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Tokyo Med University Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • Tokyo Women's Medical University Hospital

    Tokyo,
    Japan

    Active - Recruiting

  • YUUAI Medical Center

    Tomigusuku,
    Japan

    Active - Recruiting

  • Toyama Prefectural Central Hospital

    Toyama-shi,
    Japan

    Active - Recruiting

  • Juntendo Uni Urayasu Hospital

    Urayasu-shi,
    Japan

    Active - Recruiting

  • Hallym University Sacred Heart Hospital

    Anyang,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Cheonan,
    Korea, Republic of

    Active - Recruiting

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan,
    Korea, Republic of

    Active - Recruiting

  • Keimyung University Dongsan Medical Center

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Konyang University Hospital

    Daejeon,
    Korea, Republic of

    Active - Recruiting

  • Hallym University Chuncheon Sacred Heart Hospital

    Gangwon-do,
    Korea, Republic of

    Active - Recruiting

  • Wonju Severance Christian Hospital

    Gangwon-do,
    Korea, Republic of

    Active - Recruiting

  • NHIS Ilsan Hospital

    Goyang-si,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si,
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Chung-Ang University Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Konkuk University Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Korea University Medical Center (KUMC)-Korea University Anam Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Kyung Hee University Hospital at Gangdong (KUIMS)

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • The Catholic University of Korea, Seoul ST. Mary's Hospital

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Ajou University Hospital

    Suwon,
    Korea, Republic of

    Active - Recruiting

  • Paula Stradina Clinical University Hospital

    Riga,
    Latvia

    Active - Recruiting

  • Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos

    Kaunas,
    Lithuania

    Active - Recruiting

  • Vilnius University Hospital Santaros Klinikos

    Vilnius,
    Lithuania

    Active - Recruiting

  • UMC St. Radboud

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Oslo University Hospital - Ulleval Hospital

    Oslo,
    Norway

    Active - Recruiting

  • SCM Sp. Z o.o

    Krakow,
    Poland

    Active - Recruiting

  • Panstwowy Instytut Medyczny MSWiA - Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii

    Warszawa,
    Poland

    Active - Recruiting

  • Hospital Universitari Arnau de Vilanova - Lleida

    Lleida,
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Madrid

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Fundacion Jimenez Diaz

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Madrid,
    Spain

    Active - Recruiting

  • Hospital Universitario Ramon y Cajal

    Madrid,
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra - Pamplona

    Pamplona,
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla,
    Spain

    Active - Recruiting

  • Hospital Universitario Doctor Peset

    Valencia,
    Spain

    Active - Recruiting

  • Nephrology Clinic, Danderyd University Hospital

    Danderyd,
    Sweden

    Active - Recruiting

  • Sahlgrenska University Hospital

    Goteborg,
    Sweden

    Active - Recruiting

  • Uppsala University Hospital

    Uppsala,
    Sweden

    Active - Recruiting

  • Shuang Ho Hospital

    New Taipei City,
    Taiwan

    Active - Recruiting

  • Tungs' Taichung Metroharbour Hospital

    Taichung,
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital (NTUH)

    Taipei,
    Taiwan

    Active - Recruiting

  • Taipei Medical University Hospital

    Taipei,
    Taiwan

    Active - Recruiting

  • Hacettepe University Hospital

    Ankara,
    Turkey

    Active - Recruiting

  • Kocaeli University Medical School

    Kocaeli,
    Turkey

    Active - Recruiting

  • FutureMeds - Soho Road Health Centre

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Southmead Hospital

    Bristol,
    United Kingdom

    Active - Recruiting

  • FutureMeds - CPS Research

    Glasgow,
    United Kingdom

    Active - Recruiting

  • Queen Elizabeth University Hospital - Glasgow

    Glasgow,
    United Kingdom

    Active - Recruiting

  • Barts Health NHS Trust

    London,
    United Kingdom

    Active - Recruiting

  • King's College Hospital

    London,
    United Kingdom

    Active - Recruiting

  • St Pancras Clinical Research

    London,
    United Kingdom

    Active - Recruiting

  • FutureMeds Newcastle

    Newcastle-Upon-Tyne,
    United Kingdom

    Active - Recruiting

  • FutureMeds Tesside

    Stockton on Tees,
    United Kingdom

    Active - Recruiting

  • FutureMeds Liverpool

    Wirral (Liverpool),
    United Kingdom

    Active - Recruiting

  • Apogee Clinical Research, LLC

    Huntsville, Alabama 35805
    United States

    Active - Recruiting

  • Arizona Kidney Disease and Hypertension Center - Thomas Office

    Phoenix, Arizona 85016
    United States

    Active - Recruiting

  • Arizona Kidney Disease and Hypertension Center - Tuscon

    Tucson, Arizona 85741
    United States

    Active - Recruiting

  • West Coast Kidney

    Fremont, California 94538
    United States

    Active - Recruiting

  • CARE Institute - Carabello Kidney

    Los Angeles, California 90022
    United States

    Active - Recruiting

  • Providence Medical Foundation - Orange

    Orange, California 92868
    United States

    Active - Recruiting

  • Western Nephrology

    Arvada, Colorado 80002
    United States

    Active - Recruiting

  • Colorado Kidney Care

    Denver, Colorado 80230
    United States

    Active - Recruiting

  • Nephrology Associates Delaware Kidney

    Newark, Delaware 19713
    United States

    Active - Recruiting

  • South Florida Nephrology Group PA, Research Div.

    Coral Springs, Florida 33071
    United States

    Active - Recruiting

  • Dolphin Medical Research

    Doral, Florida 33172
    United States

    Active - Recruiting

  • Nephrology Associates of Central Florida

    Hollywood, Florida 32806
    United States

    Active - Recruiting

  • Tectum Medical Research, LLC

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • South Florida Research Institute

    Lauderdale Lakes, Florida 33313
    United States

    Active - Recruiting

  • Florida Kidney Physicians - Melbourne

    Melbourne, Florida 32901
    United States

    Active - Recruiting

  • Med-Care Research

    Miami, Florida 33125
    United States

    Active - Recruiting

  • On Health Research Center

    Miami, Florida 33186
    United States

    Active - Recruiting

  • Professional Research Center

    Miami, Florida 33172
    United States

    Active - Recruiting

  • Combined Research Orlando Phase I-IV

    Orlando, Florida 32807
    United States

    Active - Recruiting

  • BioResearch Partner

    Pembroke Pines, Florida 33029
    United States

    Active - Recruiting

  • D&H Pompano Research Center

    Pompano Beach, Florida 33064
    United States

    Active - Recruiting

  • Cordova Research Institute, LLC

    Sweetwater, Florida 33182
    United States

    Active - Recruiting

  • SciMerge Clinical Research

    Atlanta, Georgia 30274
    United States

    Active - Recruiting

  • Georgia Nephrology - Lawrenceville

    Lawrenceville, Georgia 30046
    United States

    Active - Recruiting

  • Randomize Now - Midtown

    Newnan, Georgia 30269
    United States

    Active - Recruiting

  • Care Institute - Chubbuck, ID

    Chubbuck, Idaho 83202
    United States

    Active - Recruiting

  • Care Institute - Idaho Falls

    Idaho Falls, Idaho 83404
    United States

    Active - Recruiting

  • CARE - Boise Kidney Institute

    Meridian, Idaho 83642
    United States

    Active - Recruiting

  • Bioluminux Clinical Research

    Naperville, Illinois 60540
    United States

    Active - Recruiting

  • Rockford Nephrology Associates

    Rockford, Illinois 61107
    United States

    Active - Recruiting

  • Nephrology Associates of Northern Illinois and Indiana (NANI)

    Indianapolis, Indiana 46227
    United States

    Active - Recruiting

  • Nephrology Physicians LLC

    Mishawaka, Indiana 46545
    United States

    Active - Recruiting

  • Nephrology Associates of Kentuckiana

    Louisville, Kentucky 40205
    United States

    Active - Recruiting

  • Velocity Clinical Research - Metairie

    Metairie, Louisiana 70006
    United States

    Active - Recruiting

  • St. Clair Nephrology Research

    Shelby, Michigan 48315
    United States

    Active - Recruiting

  • InterMed Consultants / DaVita Clinical Research, Edina

    Edina, Minnesota 55404
    United States

    Active - Recruiting

  • Mayo Clinic - Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Nephrology and Hypertension Associates, LTD

    Tupelo, Mississippi 38801
    United States

    Active - Recruiting

  • Somnos Clinical Research

    Lincoln, Nebraska 68505
    United States

    Active - Recruiting

  • DaVita Clinical Research Nevada - Las Vegas

    Las Vegas, Nevada 89129
    United States

    Active - Recruiting

  • Bioluminux Clinical Research New Jersey

    Hamilton, New Jersey 08690
    United States

    Active - Recruiting

  • New Jersey Kidney Care, LLC (FRENOVA)

    Jersey City, New Jersey 07305
    United States

    Active - Recruiting

  • Renal Medicine Associates

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • New York Nephrology Vasculitis and Glomerular Center

    Albany, New York 12209
    United States

    Active - Recruiting

  • Queens Hospital Center

    Jamaica, New York 11432
    United States

    Active - Recruiting

  • Metrolina Nephrology Associates

    Charlotte, North Carolina 28208
    United States

    Active - Recruiting

  • Nephrology Associates Inc

    East Providence, Rhode Island 02914
    United States

    Active - Recruiting

  • Hypertension & Nephrology Inc.

    Providence, Rhode Island 02904
    United States

    Active - Recruiting

  • South Carolina Clinical Research, LLC

    Orangeburg, South Carolina 29118
    United States

    Active - Recruiting

  • Knoxville Kidney Center (KKC), PLLC

    Knoxville, Tennessee 37923
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Introscience Research LLC

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Dallas Renal Group

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Renal Disease Research Institute - Dallas

    Dallas, Texas 75264
    United States

    Active - Recruiting

  • Davita Clinical Research - El Paso

    El Paso, Texas 79925
    United States

    Active - Recruiting

  • Houston Medical Research Institute, LLC (FRENOVA)

    Houston, Texas 77074
    United States

    Active - Recruiting

  • Prolato Clinical Research Center

    Houston, Texas 77054
    United States

    Active - Recruiting

  • R & H Clinical Research

    Katy, Texas 77450
    United States

    Active - Recruiting

  • North Texas Kidney Disease Associates

    Lewisville, Texas 75057
    United States

    Active - Recruiting

  • P&I Clinical Research, LLC

    Lufkin, Texas 75904
    United States

    Active - Recruiting

  • Renal Specialists of Houston

    Pasadena, Texas 77504
    United States

    Active - Recruiting

  • Utah Kidney Research Institute

    Salt Lake City, Utah 84115
    United States

    Active - Recruiting

  • University of Vermont

    Burlington, Vermont 05401
    United States

    Active - Recruiting

  • Virginia Nephrology Group

    Fairfax, Virginia 22101
    United States

    Active - Recruiting

  • Kidney and Hypertension Specialist PLLC

    Manassas, Virginia 20110
    United States

    Active - Recruiting

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