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

May 14, 2026 updated by: Alpine Immune Sciences Inc, A Subsidiary of Vertex

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Povetacicept in Adults with Immunoglobin A Nephropathy

Study Type

Interventional

Enrollment (Actual)

605

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Ballarat, Australia
        • Grampians Health Ballarat
      • Bendigo, Australia
        • Bendigo Hospital
      • Birtinya, Australia
        • Sunshine Coast University Hospital
      • Brisbane, Australia
        • Core Research Group Pty Ltd
      • Camperdown, Australia
        • Royal Prince Alfred Hospital
      • Clayton, Australia
        • Monash Health
      • Concord, Australia
        • Concord Repatriation General Hospital
      • Garran, Australia
        • Canberra Hospital
      • Gosford, Australia
        • Renal Research Gosford
      • Heidelberg, Australia
        • Austin Hospital
      • Melbourne, Australia
        • Western Health (Sunshine Hospital)
      • Murdoch, Australia
        • Fiona Stanley Hospital
      • Newcastle, Australia
        • John Hunter Hospital
      • Perth, Australia
        • Sir Charles Gairdner Hospital
      • Reservoir, Australia
        • Melbourne Renal Research
      • Southport, Australia
        • Gold Coast University Clinical Trials Unit
      • Woolloongabba, Australia
        • Princess Alexandra Hospital
  • Austria
      • Feldkirch, Austria
        • LKH Feldkirch
      • Innsbruck, Austria
        • Medizinische Universitaet Innsbruck
      • Linz, Austria
        • Ordensklinikum Linz GmbH Elisabethinen
      • Vienna, Austria
        • Medizinische Universitaet Wien
      • Wels-Grieskirchen, Austria
        • Klinikum Wels- Grieskirchen
  • Belgium
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg
      • Leuven, Belgium
        • Universitaire Ziekenhuizen Leuven
  • Brazil
      • Aracaju, Brazil
        • Centro de Pesquisa Clinica do Coracao
      • Belo Horizonte, Brazil
        • Freire Pesquisa Clinica
      • Belo Horizonte, Brazil
        • Hospital Evangelico de Belo Horizonte
      • Brasília, Brazil
        • Associacao Ampara a Saude
      • Fortaleza, Brazil
        • HU Hospital Walter Cantidio
      • Goiânia, Brazil
        • UFG Hospital de Clinicas da Universidad Federal de Golas
      • Ijuí, Brazil
        • Hospital de Caridade de Ijui
      • Joinville, Brazil
        • Fundacao Pro-Rim Santa Catarina
      • Juiz de Fora, Brazil
        • Centro Mineiro de Pesquisa
      • Monte Alegre, Brazil
        • Hospital das Clinicas Riberao Preto
      • Recife, Brazil
        • Hospital das Clinicas da Universidade Federal de Pernambuco (UFPE)
      • Rio de Janeiro, Brazil
        • Hospital Universitario Pedro Ernesto - UERJ
      • Salvador, Brazil
        • Universidade Federal da Bahia
      • Salvador, Brazil
        • Clinica Senhor do Bonfim
      • São Paulo, Brazil
        • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
      • São Paulo, Brazil
        • Hospital do Rim Fundacao Oswaldo Ramos
      • São Paulo, Brazil
        • Hospital Nove de Julho - dasa
      • Valinhos, Brazil
        • A2z Clinical Centro Avancedo de Pesquisa Clinica
  • Canada
      • Hamilton, Canada
        • St. Josephs Healthcare - Hamilton
  • China
      • Beijing, China
        • Beijing Tsinghua Changgung Hospital
      • Beijing, China
        • Peking University First Hos
      • Cangzhou, China
        • Cangzhou People's Hospital
      • Changchun, China
        • The Second Norman Bethune Hospital of Jilin University
      • Changzhi, China
        • Heping Hospital Affiliated to Changzhi Medical College
      • Chengdu, China
        • Sichuan People s Hospital
      • Chongqing, China
        • The Second Affiliated Hospital of Chongqing Medical University
      • Chongqing, China
        • Bishan Hospital of Chongqing
      • Dongguan, China
        • Dongguan People s Hospital
      • Foshan, China
        • The First People's Hospital of Foshan
      • Fuyang, China
        • Fuyang People's Hospital
      • Fuzhou, China
        • Fujian Medical University Union Hospital
      • Guangzhou, China
        • Guangdong Provincial People's Hospital
      • Guangzhou, China
        • Third Affiliated Hospital of Southern Medical University
      • Guangzhou, China
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, China
        • Zhujiang Hospital, Southern Medical University
      • Guilin, China
        • Affiliated Hospital of Guilin Medical University
      • Guiyang, China
        • Guizhou Provincial People's Hospital
      • Hangzhou, China
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Hefei, China
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, China
        • The Second Affiliated Hospital of Anhui Medical University
      • Hohhot, China
        • The Affiliated Hospital of Inner Mongolia Medical University
      • Jinan, China
        • The Second Hospital of Shandong University
      • Jinan, China
        • The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
      • Linyi, China
        • Linyi People's Hospital
      • Luoyang, China
        • The First Affiliate Hospital of Henan University of Science and Technology
      • Nanchang, China
        • The First Affiliated Hospital of NanChang University
      • Nantong, China
        • Affiliated Hospital of Nantong University
      • Ningbo, China
        • Ningbo No.2 Hospital
      • Ningbo, China
        • The First Affiliated Hospital of Ningbo University
      • Shaanxi, China
        • The First Affiliated Hospital of Xian Jiaotong University
      • Shanghai, China
        • Shanghai General Hospital
      • Shenyang, China
        • Shengjing Hospital Of China Medical University
      • Shenzhen, China
        • The University of Hong Kong - Shenzhen Hospital
      • Shijiazhuang, China
        • The Second Hospital of Hebei Medical University
      • Taian, China
        • Taian City Central Hospital
      • Taiyuan, China
        • Second Hospital of Shanxi Medical University
      • Tianjin, China
        • The Second Hospital Of Tianjin Medical University
      • Wuxi, China
        • Wuxi People s Hospital
      • Xuancheng, China
        • Xuancheng People s Hospital
      • Yancheng, China
        • Yancheng No. 1 People's Hospital
      • Yangzhou, China
        • Affiliated Hospital Yangzhou University
      • Yantai, China
        • Yantai Yuhuangding Hospital
      • Yichang, China
        • Yichang central people Hos
      • Yinchuan, China
        • General Hospital of Ningxia Medical University
  • Croatia
      • Zagreb, Croatia
        • Clinical Hospital Dubrava
      • Zagreb, Croatia
        • Clinical Hospital Merkur
      • Zagreb, Croatia
        • Polyclinic Somed
  • Czechia
      • Brno, Czechia
        • Fakultni nemocnice Brno
      • New Town, Czechia
        • Vseobecna fakultni nemocnice v Praze
      • Nový Jičín, Czechia
        • Nemocnice AGEL Nový Jičín a.s.
  • Denmark
      • Aalborg, Denmark
        • Aalborg University Hospital
      • Copenhagen, Denmark
        • Center for Cancer and Organ Diseases - Rigshospitalet - Hornum Mads
      • Hillerød, Denmark
        • Hillerod Hospital
      • Kolding, Denmark
        • Sygehus Lillebaelt - Kolding
  • Estonia
      • Tallinn, Estonia
        • North Estonia Medical Centre Foundation
      • Tartu, Estonia
        • Tartu University Hospital
  • Finland
      • Tampere, Finland
        • Tampere University Hospital
  • France
      • Bordeaux, France
        • Groupe Hospitalier Pellegrin, CHU De Bordeaux
      • Créteil, France
        • Hôpitaux Universitaires Henri Mondor
      • Le Puy-en-Velay, France
        • Centre Hospitalier Emile Roux
      • Marseille, France
        • AP-HM - Hopital de La Conception
      • Nantes, France
        • CHU de Nantes - Hotel-Dieu
      • Paris, France
        • Hôpital Necker - Enfants Malades
      • Paris, France
        • Université Paris-Descartes / Hôpital Européen Georges Pompidou
      • Saint-Priest-en-Jarez, France
        • Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
      • Valenciennes, France
        • Centre Hospitalier de Valencienes
  • Germany
      • Aachen, Germany
        • Medizinische Klinik II
      • Berlin, Germany
        • Charite Universitaetsnedizin Berlin
      • Dresden, Germany
        • Universitaetsklinikum Carl Gustav Carus Dresden
      • Leipzig, Germany
        • Universitaetsklinikum Leipzig
      • Leipzig, Germany
        • Klinikum St Georg
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, Hong Kong
        • Prince Wales Hospital
      • Sheung Wan, Hong Kong
        • Tung Wah Hospital
  • Hungary
      • Pécs, Hungary
        • Pécsi Tudományegyetem Klinikai Központ
  • Ireland
      • Cork, Ireland
        • Cork University Hospital
      • Dublin, Ireland
        • Beaumont Hospital
      • Galway, Ireland
        • University Hospital Galway
      • Waterford, Ireland
        • University Hospital Waterford
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
      • Petah Tivka, Israel
        • Rabin Medical Center
      • Tel Litwinsky, Israel
        • Sheba Medical Center
      • Ẕerifin, Israel
        • Shamir Medical Center
  • Italy
      • Bari, Italy
        • Azienda Ospedaliera Universitaria Consorziale - policlinicio Bari
      • Genova, Italy
        • Ospedale Policlinico San Martino IRCCS
      • Modena, Italy
        • AOU Policlinico di Modena
      • Pavia, Italy
        • Istituti Clinici Scientifici Maugeri-IRCCS Pavia
      • Rome, Italy
        • Fondazione Policlinico Universitario A. Gemelli
  • Japan
      • Aichi, Japan
        • Fujita Health University Hos
      • Amagasaki, Japan
        • Hyogo Amagasaki Gen Med Ctr
      • Fukuoka, Japan
        • Fukuoka University Hospital
      • Fukuoka, Japan
        • Japanese Red Cross Fukuoka Hospital
      • Itabashi-ku, Japan
        • Nihon University Itabashi Hospital
      • Kahoku, Japan
        • Kanazawa Medical Uni Hospital
      • Kanazawa, Japan
        • Kanazawa University Hospital
      • Kashihara, Japan
        • Nara Med University Hos
      • Kasugai, Japan
        • Kasugai Municipal Hospital
      • Kita-ku, Japan
        • Okayama University Hospital
      • Kitakyushu-shi, Japan
        • Kokura Memorial Hospital
      • Kobe, Japan
        • Kobe University Hospital
      • Koshigaya, Japan
        • Dokkyo Medical University Saitama Medical Center
      • Kyoto, Japan
        • Kyoto University Hospital
      • Kyoto, Japan
        • Japanese Red Cross Kyoto Daini Hospital
      • Miyazaki, Japan
        • University of Miyazaki Hos
      • Osaka, Japan
        • Osaka City General Hospital
      • Osaka, Japan
        • Osaka General Medical Center
      • Sapporo, Japan
        • Sapporo City General Hospital
      • Sendai, Japan
        • Tohoku University Tohoku University Hospital
      • Tokyo, Japan
        • Tokyo Women's Medical University Hospital
      • Tokyo, Japan
        • Juntendo University Nerima Hospital
      • Tokyo, Japan
        • Juntendo Hospital Affiliated to Juntendo University School of Medicine
      • Tokyo, Japan
        • The Jikei Uni Daisan Hospital
      • Tokyo, Japan
        • The Jikei University Hospital
      • Tokyo, Japan
        • Tokyo Med University Hospital
      • Tomigusuku, Japan
        • YUUAI Medical Center
      • Toyama, Japan
        • Toyama Prefectural Central Hospital
      • Urayasu-shi, Japan
        • Juntendo Uni Urayasu Hospital
  • Latvia
      • Riga, Latvia
        • Paula Stradina Clinical University Hospital
      • Valmiera, Latvia
        • Vidzemes Hospital
  • Lithuania
      • Kaunas, Lithuania
        • Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
      • Vilnius, Lithuania
        • Vilnius University Hospital Santaros Klinikos
  • Mexico
      • Veracruz, Mexico
        • Arke SMO SA de CV
  • Netherlands
      • Groningen, Netherlands
        • University Medical Center Groningen
      • Nijmegen, Netherlands
        • UMC St. Radboud
  • Norway
      • Bergen, Norway
        • Haukeland University Hospital
      • Oslo, Norway
        • Oslo University Hospital - Ulleval Hospital
  • Poland
      • Krakow, Poland
        • SCM Sp. Z o.o
      • Lodzkie, Poland
        • Klinika Nefrologii, Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
      • Szczecin, Poland
        • Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie
      • Warsaw, Poland
        • Panstwowy Instytut Medyczny MSWiA - Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii
      • Zamość, Poland
        • Velocity Zamosc
  • Saudi Arabia
      • Dammam, Saudi Arabia
        • King Fahad Specialist Hospital, Dammam
      • Riyadh, Saudi Arabia
        • King Saud University, King Saud University Medical City
  • South Korea
      • Anyang, South Korea
        • Hallym University Sacred Heart Hospital
      • Cheonan, South Korea
        • Seoul National University Hospital
      • Cheonan, South Korea
        • Soon Chun Hyang University Cheonan Hospital
      • Daegu, South Korea
        • Keimyung University Dongsan Medical Center
      • Daegu, South Korea
        • Kyungpook National University Hospital
      • Daejeon, South Korea
        • Konyang University Hospital
      • Gangwon-do, South Korea
        • Hallym University Chuncheon Sacred Heart Hospital
      • Gangwon-do, South Korea
        • WonJu Severance Christian Hospital
      • Goyang-si, South Korea
        • NHIS Ilsan Hospital
      • Seongnam-si, South Korea
        • Seoul National University Bundang Hospital
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Korea University Guro Hospital
      • 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
        • Konkuk University Medical Center
      • Seoul, South Korea
        • Chung-Ang University Hospital
      • Seoul, South Korea
        • Korea University Medical Center (KUMC)-Korea University Anam Hospital
      • Seoul, South Korea
        • Kyung Hee University Hospital at Gangdong (KUIMS)
      • Suwon, South Korea
        • Ajou University Hospital
      • Yongin-si, South Korea
        • Yongin Severance Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Universitari de Bellvitge
      • Barcelona, Spain
        • Hospital Universitatio Vall d'Hebron
      • Córdoba, Spain
        • Hospital Universitario Reina Sofia
      • Lleida, Spain
        • Hospital Universitari Arnau de Vilanova - Lleida
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain
        • Hospital Fundación Jiménez Díaz
      • Madrid, Spain
        • Clínica Universidad de Navarra - Madrid
      • Pamplona, Spain
        • Clinica Universidad de Navarra - Pamplona
      • Santiago de Compostela, Spain
        • Hospital Clínico Universitario de Santiago
      • Seville, Spain
        • Hospital Universitario Virgen Macarena
      • Valencia, Spain
        • Hospital Universitario Doctor Peset
  • Sweden
      • Danderyd, Sweden
        • Nephrology Clinic, Danderyd University Hospital
      • Gothenburg, Sweden
        • Sahlgrenska University Hospital
      • Huddinge, Sweden
        • Karolinska University Hospital Huddinge
      • Linköping, Sweden
        • Linkoping University Hospital
      • Uppsala, Sweden
        • Uppsala University Hospital
  • Taiwan
      • New Taipei City, Taiwan
        • Shuang Ho Hospital
      • Taichung, Taiwan
        • Tungs' Taichung Metroharbour Hospital
      • Taipei, Taiwan
        • Taipei Medical University Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital (NTUH)
      • Taipei, Taiwan
        • Taipei Veterans General Hospital (TP-VGH)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Hacettepe University Hospital
      • Istanbul, Turkey (Türkiye)
        • Istanbul University Cerrahpasa Medical Faculty
      • Kocaeli, Turkey (Türkiye)
        • Kocaeli University Medical School
  • United Kingdom
      • Belfast, United Kingdom
        • Belfast Health and Social Care Trust
      • Birmingham, United Kingdom
        • FutureMeds - Soho Road Health Centre
      • Bristol, United Kingdom
        • Southmead Hospital
      • Cambridge, United Kingdom
        • Cambridge University - Addenbrooke's Hospital
      • Glasgow, United Kingdom
        • Queen Elizabeth University Hospital - Glasgow
      • Glasgow, United Kingdom
        • FutureMeds - CPS Research
      • Gloucester, United Kingdom
        • Gloucestershire Royal Hospital
      • Leicester, United Kingdom
        • Leicester General Hospital
      • London, United Kingdom
        • Imperial College Healthcare NHS Trust
      • London, United Kingdom
        • Barts Health NHS Trust
      • London, United Kingdom
        • King's College Hospital
      • London, United Kingdom
        • St Pancras Clinical Research
      • Manchester, United Kingdom
        • University of Manchester, Manchester Royal Infirmary
      • Newcastle upon Tyne, United Kingdom
        • FutureMeds Newcastle
      • Stockton-on-Tees, United Kingdom
        • FutureMeds Tesside
      • Wirral (Liverpool), United Kingdom
        • FutureMeds Liverpool
      • Wolverhampton, United Kingdom
        • Royal Wolverhampton Nhs Trust
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
        • Apogee Clinical Research, LLC
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Arizona Kidney Disease and Hypertension Center - Thomas Office
      • Tucson, Arizona, United States, 85741
        • Arizona Kidney Disease and Hypertension Center - Tuscon
    • California
      • Fremont, California, United States, 94538
        • West Coast Kidney
      • Fresno, California, United States, 93720
        • The Medical Research Group, Inc. (FRENOVA)
      • Los Angeles, California, United States, 90022
        • CARE Institute - Carabello Kidney
      • Orange, California, United States, 92868
        • Providence Medical Foundation - Orange
      • Riverside, California, United States, 92505
        • National Nephrology Alliance Research
      • Sacramento, California, United States, 95819
        • UC Davis Health
      • San Francisco, California, United States, 94143
        • University of California San Francisco (UCSF)
      • San Francisco, California, United States, 94110
        • Zuckerberg San Francisco General Hospital and Trauma Center
    • Colorado
      • Arvada, Colorado, United States, 80002
        • Western Nephrology
      • Denver, Colorado, United States, 80230
        • Colorado Kidney Care
    • Delaware
      • Newark, Delaware, United States, 19713
        • Nephrology Associates Delaware Kidney (FRENOVA)
    • Florida
      • Coral Springs, Florida, United States, 33071
        • South Florida Nephrology Group PA, Research Div.
      • Doral, Florida, United States, 33172
        • Dolphin Medical Research
      • Hollywood, Florida, United States, 32806
        • Nephrology Associates of Central Florida
      • Hollywood, Florida, United States, 33024
        • Tectum Medical Research, LLC
      • Lauderdale Lakes, Florida, United States, 33313
        • South Florida Research Institute
      • Melbourne, Florida, United States, 32901
        • Florida Kidney Physicians - Melbourne
      • Miami, Florida, United States, 33173
        • Nephrology Associates of South Miami
      • Miami, Florida, United States, 33125
        • Med-Care Research
      • Miami, Florida, United States, 33172
        • Professional Research Center
      • Miami, Florida, United States, 33186
        • On Health Research Center
      • Orlando, Florida, United States, 32807
        • Combined Research Orlando Phase I-IV
      • Pembroke Pines, Florida, United States, 33029
        • BioResearch Partner
      • Pompano Beach, Florida, United States, 33064
        • D&H Pompano Research Center
      • Sweetwater, Florida, United States, 33182
        • Cordova Research Institute, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30274
        • SciMerge Clinical Research
      • Lawrenceville, Georgia, United States, 30046
        • Georgia Nephrology - Lawrenceville
      • Newnan, Georgia, United States, 30269
        • Randomize Now - Midtown
    • Idaho
      • Chubbuck, Idaho, United States, 83202
        • Care Institute - Chubbuck, ID
      • Idaho Falls, Idaho, United States, 83404
        • CARE Institute - Idaho Falls
      • Meridian, Idaho, United States, 83642
        • CARE - Boise Kidney Institute
    • Illinois
      • Naperville, Illinois, United States, 60540
        • Bioluminux Clinical Research
      • Rockford, Illinois, United States, 61107
        • Rockford Nephrology Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Nephrology Associates of Northern Illinois and Indiana (NANI)
      • Mishawaka, Indiana, United States, 46545
        • Nephrology Physicians LLC
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Nephrology Associates of Kentuckiana
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Renal Associates of Baton Rouge
      • Metairie, Louisiana, United States, 70006
        • Velocity Clinical Research - Metairie
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins School of Medicine
    • Michigan
      • Shelby, Michigan, United States, 48315
        • St. Clair Nephrology Research
    • Minnesota
      • Edina, Minnesota, United States, 55404
        • InterMed Consultants / DaVita Clinical Research, Edina
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - Rochester
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Nephrology and Hypertension Associates, LTD
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Nebraska
      • Lincoln, Nebraska, United States, 68505
        • Somnos Clinical Research
    • Nevada
      • Las Vegas, Nevada, United States, 89129
        • DaVita Clinical Research Nevada - Las Vegas
    • New Jersey
      • Hamilton, New Jersey, United States, 08690
        • Bioluminux Clinical Research New Jersey
      • Jersey City, New Jersey, United States, 07305
        • New Jersey Kidney Care, LLC (FRENOVA)
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Renal Medicine Associates
    • New York
      • Albany, New York, United States, 12209
        • New York Nephrology Vasculitis and Glomerular Center
      • Jamaica, New York, United States, 11432
        • Queens Hospital Center
      • New York, New York, United States, 10021
        • The Rogosin Institute
    • North Carolina
      • Charlotte, North Carolina, United States, 28208
        • Metrolina Nephrology Associates
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Nephrology Associates Inc
      • Providence, Rhode Island, United States, 02904
        • Hypertension & Nephrology Inc.
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • South Carolina Clinical Research, LLC
    • Tennessee
      • Knoxville, Tennessee, United States, 37923
        • Knoxville Kidney Center (KKC), PLLC
    • Texas
      • Abilene, Texas, United States, 79606
        • Velocity Clinical Research
      • Bellaire, Texas, United States, 77401
        • Introscience Research LLC
      • Dallas, Texas, United States, 75230
        • Dallas Renal Group
      • Dallas, Texas, United States, 75264
        • Renal Disease Research Institute - Dallas
      • El Paso, Texas, United States, 79925
        • Davita Clinical Research - El Paso
      • Houston, Texas, United States, 77054
        • Prolato Clinical Research Center
      • Houston, Texas, United States, 77074
        • Houston Medical Research Institute, LLC (FRENOVA)
      • Katy, Texas, United States, 77450
        • R & H Clinical Research
      • Lewisville, Texas, United States, 75057
        • North Texas Kidney Disease Associates
      • Lufkin, Texas, United States, 75904
        • P&I Clinical Research, LLC
      • Pasadena, Texas, United States, 77504
        • Renal Specialists of Houston
    • Utah
      • Salt Lake City, Utah, United States, 84115
        • Utah Kidney Research Institute
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont
    • Virginia
      • Fairfax, Virginia, United States, 22101
        • Virginia Nephrology Group
      • Manassas, Virginia, United States, 20110
        • Kidney and Hypertension Specialist PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36
Time Frame: From Baseline at Week 36
From Baseline at Week 36
Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104
Time Frame: From Baseline Through Week 104
From Baseline Through Week 104

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in eGFR at Week 104
Time Frame: From Baseline at Week 104
From Baseline at Week 104
Change from Baseline in Serum Gd-IgA1 at Week 36
Time Frame: From Baseline at Week 36
From Baseline at Week 36
Proportion of Participants to Achieve Hematuria Resolution at Week 36 (Among Participants With Hematuria at Baseline)
Time Frame: From Baseline at Week 36
From Baseline at Week 36
Time to Kidney Disease Progression Through Week 104
Time Frame: From Baseline Through Week 104
Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death
From Baseline Through Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alpine Immune Sciences Inc, A Subsidiary of Vertex

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

January 30, 2028

Study Registration Dates

First Submitted

August 19, 2024

First Submitted That Met QC Criteria

August 19, 2024

First Posted (Actual)

August 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX24-AIS-D08
  • 2024-514135-17-00 (Other Identifier: EU CT number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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