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ACTIVE NOT RECRUITING
NCT06564142
PHASE3

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

Sponsor: Alpine Immune Sciences Inc, A Subsidiary of Vertex

View on ClinicalTrials.gov

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.

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

605

Start Date

2024-08-30

Completion Date

2028-01-30

Last Updated

2025-12-17

Healthy Volunteers

No

Interventions

DRUG

Povetacicept

Subcutaneous injection administration.

DRUG

Placebo (matched to Povetacicept)

Placebo matched to Povetacicept subcutaneous injection administration.

Locations (318)

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

Providence Medical Foundation - Orange

Orange, California, United States

National Nephrology Alliance Research

Riverside, California, United States

UC Davis Health

Sacramento, California, United States

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, United States

University of California San Francisco (UCSF)

San Francisco, California, United States

Western Nephrology

Arvada, Colorado, United States

Colorado Kidney Care

Denver, Colorado, United States

Nephrology Associates Delaware Kidney (FRENOVA)

Newark, Delaware, United States

South Florida Nephrology Group PA, Research Div.

Coral Springs, Florida, United States

Dolphin Medical Research

Doral, Florida, United States

Nephrology Associates of Central Florida

Hollywood, Florida, United States

Tectum Medical Research, LLC

Hollywood, Florida, United States

South Florida Research Institute

Lauderdale Lakes, Florida, United States

Florida Kidney Physicians - Melbourne

Melbourne, Florida, United States

Med-Care Research

Miami, Florida, United States

Professional Research Center

Miami, Florida, United States

Nephrology Associates of South Miami

Miami, Florida, United States

On Health Research Center

Miami, Florida, United States

Combined Research Orlando Phase I-IV

Orlando, Florida, United States

BioResearch Partner

Pembroke Pines, Florida, United States

D&H Pompano Research Center

Pompano Beach, Florida, United States

Cordova Research Institute, LLC

Sweetwater, Florida, United States

SciMerge Clinical Research

Atlanta, Georgia, United States

Georgia Nephrology - Lawrenceville

Lawrenceville, Georgia, United States

Randomize Now - Midtown

Newnan, 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

Bioluminux Clinical Research

Naperville, Illinois, United States

Rockford Nephrology Associates

Rockford, Illinois, United States

Nephrology Associates of Northern Illinois and Indiana (NANI)

Indianapolis, Indiana, United States

Nephrology Physicians LLC

Mishawaka, Indiana, United States

Nephrology Associates of Kentuckiana

Louisville, Kentucky, United States

Renal Associates of Baton Rouge

Baton Rouge, Louisiana, United States

Velocity Clinical Research - Metairie

Metairie, Louisiana, United States

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

St. Clair Nephrology Research

Shelby, Michigan, United States

InterMed Consultants / DaVita Clinical Research, Edina

Edina, Minnesota, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Nephrology and Hypertension Associates, LTD

Tupelo, Mississippi, United States

Washington University in St. Louis

St Louis, Missouri, United States

Somnos Clinical Research

Lincoln, Nebraska, United States

DaVita Clinical Research Nevada - Las Vegas

Las Vegas, Nevada, United States

Bioluminux Clinical Research New Jersey

Hamilton, New Jersey, United States

New Jersey Kidney Care, LLC (FRENOVA)

Jersey City, New Jersey, United States

Renal Medicine Associates

Albuquerque, New Mexico, United States

New York Nephrology Vasculitis and Glomerular Center

Albany, New York, United States

Queens Hospital Center

Jamaica, New York, United States

The Rogosin Institute

New York, New York, United States

Metrolina Nephrology Associates

Charlotte, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Nephrology Associates Inc

East Providence, Rhode Island, United States

Hypertension & Nephrology Inc.

Providence, Rhode Island, United States

South Carolina Clinical Research, LLC

Orangeburg, South Carolina, United States

Knoxville Kidney Center (KKC), PLLC

Knoxville, Tennessee, United States

Velocity Clinical Research

Abilene, Texas, United States

Introscience Research LLC

Bellaire, Texas, United States

Dallas Renal Group

Dallas, Texas, United States

Renal Disease Research Institute - Dallas

Dallas, Texas, United States

Davita Clinical Research - El Paso

El Paso, Texas, United States

Prolato Clinical Research Center

Houston, Texas, United States

Houston Medical Research Institute, LLC (FRENOVA)

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

University of Vermont

Burlington, Vermont, United States

Virginia Nephrology Group

Fairfax, Virginia, United States

Kidney and Hypertension Specialist PLLC

Manassas, Virginia, United States

Grampians Health Ballarat

Ballarat, Australia

Bendigo Hospital

Bendigo, Australia

Sunshine Coast University Hospital

Birtinya, Australia

Core Research Group Pty Ltd

Brisbane, Australia

Royal Prince Alfred Hospital

Camperdown, Australia

Monash Health

Clayton, Australia

Concord Repatriation General Hospital

Concord, Australia

Canberra Hospital

Garran, Australia

Renal Research Gosford

Gosford, Australia

Austin Hospital

Heidelberg, Australia

Western Health (Sunshine Hospital)

Melbourne, Australia

Fiona Stanley Hospital

Murdoch, Australia

John Hunter Hospital

Newcastle, Australia

Sir Charles Gairdner Hospital

Perth, Australia

Melbourne Renal Research

Reservoir, Australia

Gold Coast University Clinical Trials Unit

Southport, Australia

Princess Alexandra Hospital

Woolloongabba, Australia

LKH Feldkirch

Feldkirch, Austria

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria

Medizinische Universitaet Wien

Vienna, Austria

Klinikum Wels- Grieskirchen

Wels-Grieskirchen, Austria

Ziekenhuis Oost-Limburg

Genk, Belgium

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Centro de Pesquisa Clinica do Coracao

Aracaju, Brazil

Freire Pesquisa Clinica

Belo Horizonte, Brazil

Hospital Evangelico de Belo Horizonte

Belo Horizonte, Brazil

Associacao Ampara a Saude

Brasília, Brazil

HU Hospital Walter Cantidio

Fortaleza, Brazil

UFG Hospital de Clinicas da Universidad Federal de Golas

Goiânia, Brazil

Hospital de Caridade de Ijui

Ijuí, Brazil

Fundacao Pro-Rim Santa Catarina

Joinville, Brazil

Centro Mineiro de Pesquisa

Juiz de Fora, Brazil

Hospital das Clinicas Riberao Preto

Monte Alegre, Brazil

Hospital das Clinicas da Universidade Federal de Pernambuco (UFPE)

Recife, Brazil

Hospital Universitario Pedro Ernesto - UERJ

Rio de Janeiro, Brazil

Clinica Senhor do Bonfim

Salvador, Brazil

Universidade Federal da Bahia

Salvador, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, Brazil

Hospital do Rim Fundacao Oswaldo Ramos

São Paulo, Brazil

Hospital Nove de Julho - DASA

São Paulo, Brazil

A2z Clinical Centro Avancedo de Pesquisa Clinica

Valinhos, Brazil

St. Josephs Healthcare - Hamilton

Hamilton, Canada

Beijing Tsinghua Changgung Hospital

Beijing, China

Peking University First Hos

Beijing, China

Cangzhou People's Hospital

Cangzhou, China

The Second Norman Bethune Hospital of Jilin University

Changchun, China

Heping Hospital Affiliated to Changzhi Medical College

Changzhi, China

Sichuan People s Hospital

Chengdu, China

Bishan Hospital of Chongqing

Chongqing, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

Dongguan People s Hospital

Dongguan, China

The First People's Hospital of Foshan

Foshan, China

Fuyang People's Hospital

Fuyang, China

Fujian Medical University Union Hospital

Fuzhou, China

Guangdong Provincial People's Hospital

Guangzhou, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Third Affiliated Hospital of Southern Medical University

Guangzhou, China

Zhujiang Hospital, Southern Medical University

Guangzhou, China

Affiliated Hospital of Guilin Medical University

Guilin, China

Guizhou Provincial People's Hospital

Guiyang, China

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, China

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

Jinan, China

The Second Hospital of Shandong University

Jinan, China

Linyi People's Hospital

Linyi, China

The First Affiliate Hospital of Henan University of Science and Technology

Luoyang, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

Affiliated Hospital of Nantong University

Nantong, China

Ningbo No.2 Hospital

Ningbo, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

The First Affiliated Hospital of Xian JiaoTong University

Shaanxi, China

Shanghai General Hospital

Shanghai, China

Shengjing Hospital of China Medical University

Shenyang, China

The University of Hong Kong - Shenzhen Hospital

Shenzhen, China

The Second Hospital of Hebei Medical University

Shijiazhuang, China

Taian City Central Hospital

Taian, China

Second Hospital of Shanxi Medical University

Taiyuan, China

The Second Hospital of Tianjin Medical University

Tianjin, China

Wuxi People s Hospital

Wuxi, China

Xuancheng People s Hospital

Xuancheng, China

Yancheng No. 1 People's Hospital

Yancheng, China

Affiliated Hospital Yangzhou University

Yangzhou, China

Yantai YuHuangDing Hospital

Yantai, China

Yichang central people Hos

Yichang, China

General Hospital of Ningxia Medical University

Yinchuan, China

Clinical Hospital Dubrava

Zagreb, Croatia

Clinical Hospital Merkur

Zagreb, Croatia

Polyclinic Somed

Zagreb, Croatia

Fakultni Nemocnice Brno

Brno, Czechia

Vseobecna fakultni nemocnice v Praze

New Town, Czechia

Nemocnice AGEL Novy Jicin a.s.

Nový Jičín, Czechia

Aalborg University Hospital

Aalborg, Denmark

Center for Cancer and Organ Diseases - Rigshospitalet - Hornum Mads

Copenhagen, Denmark

Hillerod Hospital

Hillerød, Denmark

Sygehus Lillebaelt - Kolding

Kolding, Denmark

North Estonia Medical Centre Foundation

Tallinn, Estonia

Tartu University Hospital

Tartu, Estonia

Tampere University Hospital

Tampere, Finland

Groupe Hospitalier Pellegrin, CHU De Bordeaux

Bordeaux, France

Hopitaux Universitaires Henri Mondor

Créteil, France

Centre Hospitalier Emile Roux

Le Puy-en-Velay, France

AP-HM - Hopital de La Conception

Marseille, France

CHU de Nantes - Hotel-Dieu

Nantes, France

Hopital Necker - Enfants Malades

Paris, France

Université Paris-Descartes / Hôpital Européen Georges Pompidou

Paris, France

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

Saint-Priest-en-Jarez, France

Centre Hospitalier de Valencienes

Valenciennes, France

Medizinische Klinik II

Aachen, Germany

Charite Universitaetsnedizin Berlin

Berlin, Germany

Universitaetsklinikum Carl Gustav Carus Dresden

Dresden, Germany

Klinikum St Georg

Leipzig, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Queen Mary Hospital

Hong Kong, Hong Kong

Prince Wales Hospital

Shatin, Hong Kong

Tung Wah Hospital

Sheung Wan, Hong Kong

Pecsi Tudomanyegyetem Klinikai Kozpont

Pécs, Hungary

Cork University Hospital

Cork, Ireland

Beaumont Hospital

Dublin, Ireland

University Hospital Galway

Galway, Ireland

University Hospital Waterford

Waterford, Ireland

Barzilai Medical Center

Ashkelon, Israel

Rabin Medical Center

Petah Tivka, Israel

Sheba Medical Center

Tel Litwinsky, Israel

Shamir Medical Center

Ẕerifin, Israel

Azienda Ospedaliera Universitaria Consorziale - policlinicio Bari

Bari, Italy

Ospedale Policlinico San Martino IRCCS

Genova, Italy

AOU Policlinico di Modena

Modena, Italy

Istituti Clinici Scientifici Maugeri-IRCCS Pavia

Pavia, Italy

Fondazione Policlinico Universitario A. Gemelli

Rome, Italy

Fujita Health University Hos

Aichi, Japan

Hyogo Amagasaki Gen Med Ctr

Amagasaki, Japan

Fukuoka University Hospital

Fukuoka, Japan

Japanese Red Cross Fukuoka Hospital

Fukuoka, Japan

Nihon University Itabashi Hospital

Itabashi-ku, Japan

Kanazawa Medical Uni Hospital

Kahoku, Japan

Kanazawa University Hospital

Kanazawa, Japan

Nara Med University Hos

Kashihara, Japan

Kasugai Municipal Hospital

Kasugai, Japan

Okayama University Hospital

Kita-ku, Japan

Kokura Memorial Hospital

Kitakyushu-shi, Japan

Kobe University Hospital

Kobe, Japan

Dokkyo Medical University Saitama Medical Center

Koshigaya, Japan

Japanese Red Cross Kyoto Daini Hospital

Kyoto, Japan

Kyoto University Hospital

Kyoto, Japan

University of Miyazaki Hos

Miyazaki, Japan

Osaka City General Hospital

Osaka, Japan

Osaka General Medical Center

Osaka, Japan

Sapporo City General Hospital

Sapporo, Japan

Tohoku University Tohoku University Hospital

Sendai, Japan

Juntendo Hospital Affiliated to Juntendo University School of Medicine

Tokyo, Japan

Juntendo University Nerima Hospital

Tokyo, Japan

The Jikei Uni Daisan Hospital

Tokyo, Japan

The Jikei University Hospital

Tokyo, Japan

Tokyo Med University Hospital

Tokyo, Japan

Tokyo Women's Medical University Hospital

Tokyo, Japan

YUUAI Medical Center

Tomigusuku, Japan

Toyama Prefectural Central Hospital

Toyama, Japan

Juntendo Uni Urayasu Hospital

Urayasu-shi, Japan

Paula Stradina Clinical University Hospital

Riga, Latvia

Vidzemes Hospital

Valmiera, Latvia

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

Kaunas, Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Arke SMO SA de CV

Veracruz, Mexico

University Medical Center Groningen

Groningen, Netherlands

UMC St. Radboud

Nijmegen, Netherlands

Haukeland University Hospital

Bergen, Norway

Oslo University Hospital - Ulleval Hospital

Oslo, Norway

SCM Sp. Z o.o

Krakow, Poland

Klinika Nefrologii, Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

Lodzkie, Poland

Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie

Szczecin, Poland

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

Warsaw, Poland

Velocity Zamosc

Zamość, Poland

King Fahad Specialist Hospital, Dammam

Dammam, Saudi Arabia

King Saud University, King Saud University Medical City

Riyadh, Saudi Arabia

Hallym University Sacred Heart Hospital

Anyang, South Korea

Seoul National University Hospital

Cheonan, South Korea

Soon Chun Hyang University Cheonan Hospital

Cheonan, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Kyungpook National University Hospital

Daegu, South Korea

Konyang University Hospital

Daejeon, South Korea

Hallym University Chuncheon Sacred Heart Hospital

Gangwon-do, South Korea

Wonju Severance Christian Hospital

Gangwon-do, South Korea

NHIS Ilsan Hospital

Goyang-si, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Korea University Guro Hospital

Seoul, South Korea

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

Seoul, South Korea

Kyung Hee University Hospital at Gangdong (KUIMS)

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

The Catholic University of Korea Eunpyeong St. Mary's Hospital

Seoul, South Korea

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

Seoul, South Korea

Ajou University Hospital

Suwon, South Korea

Yongin Severance Hospital

Yongin-si, South Korea

Hospital Universitari de Bellvitge

Barcelona, Spain

Hospital Universitatio Vall d'Hebron

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Hospital Universitari Arnau de Vilanova - Lleida

Lleida, Spain

Clinica Universidad de Navarra - Madrid

Madrid, Spain

Hospital Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Spain

Hospital Universitario Ramon y Cajal

Madrid, Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, Spain

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitario Doctor Peset

Valencia, Spain

Nephrology Clinic, Danderyd University Hospital

Danderyd, Sweden

Sahlgrenska University Hospital

Gothenburg, Sweden

Karolinska University Hospital Huddinge

Huddinge, Sweden

Linkoping University Hospital

Linköping, Sweden

Uppsala University Hospital

Uppsala, Sweden

Shuang Ho Hospital

New Taipei City, Taiwan

Tungs' Taichung Metroharbour Hospital

Taichung, Taiwan

National Taiwan University Hospital (NTUH)

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital (TP-VGH)

Taipei, Taiwan

Hacettepe University Hospital

Ankara, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Kocaeli University Medical School

Kocaeli, Turkey (Türkiye)

Belfast Health and Social Care Trust

Belfast, United Kingdom

FutureMeds - Soho Road Health Centre

Birmingham, United Kingdom

Southmead Hospital

Bristol, United Kingdom

Cambridge University - Addenbrooke's Hospital

Cambridge, United Kingdom

FutureMeds - CPS Research

Glasgow, United Kingdom

Queen Elizabeth University Hospital - Glasgow

Glasgow, United Kingdom

Gloucestershire Royal Hospital

Gloucester, United Kingdom

Leicester General Hospital

Leicester, United Kingdom

Barts Health NHS Trust

London, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

King's College Hospital

London, United Kingdom

St Pancras Clinical Research

London, United Kingdom

University of Manchester, Manchester Royal Infirmary

Manchester, United Kingdom

FutureMeds Newcastle

Newcastle upon Tyne, United Kingdom

FutureMeds Tesside

Stockton-on-Tees, United Kingdom

FutureMeds Liverpool

Wirral (Liverpool), United Kingdom

Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom