AzTrials
AzTrials

Immunoglobulin A NephropathyPhase 3NCT06564142

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

A Phase 3 study testing Povetacicept in people with Immunoglobulin A Nephropathy, run by Alpine Immune Sciences Inc, A Subsidiary of Vertex at 318 sites in 33 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immunoglobulin A Nephropathy
What is being tested?
Povetacicept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
605 participants
Where
318 sitesin 33 countries
Study dates
30 Aug 2024to 30 Jan 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

318 sites in 33 countries.

318 sites in 33 countries

United States77 sites

  • Velocity Clinical Research

    Abilene, Texas, 79606

  • New York Nephrology Vasculitis and Glomerular Center

    Albany, New York, 12209

  • Renal Medicine Associates

    Albuquerque, New Mexico, 87109

  • Western Nephrology

    Arvada, Colorado, 80002

  • SciMerge Clinical Research

    Atlanta, Georgia, 30274

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21287

  • Renal Associates of Baton Rouge

    Baton Rouge, Louisiana, 70808

  • Introscience Research LLC

    Bellaire, Texas, 77401

  • University of Vermont

    Burlington, Vermont, 05401

  • Metrolina Nephrology Associates

    Charlotte, North Carolina, 28208

  • Care Institute - Chubbuck, ID

    Chubbuck, Idaho, 83202

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • South Florida Nephrology Group PA, Research Div.

    Coral Springs, Florida, 33071

  • Dallas Renal Group

    Dallas, Texas, 75230

  • Renal Disease Research Institute - Dallas

    Dallas, Texas, 75264

  • Colorado Kidney Care

    Denver, Colorado, 80230

  • Dolphin Medical Research

    Doral, Florida, 33172

  • Nephrology Associates Inc

    East Providence, Rhode Island, 02914

  • InterMed Consultants / DaVita Clinical Research, Edina

    Edina, Minnesota, 55404

  • Davita Clinical Research - El Paso

    El Paso, Texas, 79925

  • Virginia Nephrology Group

    Fairfax, Virginia, 22101

  • West Coast Kidney

    Fremont, California, 94538

  • The Medical Research Group, Inc. (FRENOVA)

    Fresno, California, 93720

  • Bioluminux Clinical Research New Jersey

    Hamilton, New Jersey, 08690

  • Nephrology Associates of Central Florida

    Hollywood, Florida, 32806

  • Tectum Medical Research, LLC

    Hollywood, Florida, 33024

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • Houston Medical Research Institute, LLC (FRENOVA)

    Houston, Texas, 77074

  • Apogee Clinical Research, LLC

    Huntsville, Alabama, 35805

  • Care Institute - Idaho Falls

    Idaho Falls, Idaho, 83404

  • Nephrology Associates of Northern Illinois and Indiana (NANI)

    Indianapolis, Indiana, 46227

  • Queens Hospital Center

    Jamaica, New York, 11432

  • New Jersey Kidney Care, LLC (FRENOVA)

    Jersey City, New Jersey, 07305

  • R & H Clinical Research

    Katy, Texas, 77450

  • Knoxville Kidney Center (KKC), PLLC

    Knoxville, Tennessee, 37923

  • DaVita Clinical Research Nevada - Las Vegas

    Las Vegas, Nevada, 89129

  • South Florida Research Institute

    Lauderdale Lakes, Florida, 33313

  • Georgia Nephrology - Lawrenceville

    Lawrenceville, Georgia, 30046

  • North Texas Kidney Disease Associates

    Lewisville, Texas, 75057

  • Somnos Clinical Research

    Lincoln, Nebraska, 68505

  • CARE Institute - Carabello Kidney

    Los Angeles, California, 90022

  • Nephrology Associates of Kentuckiana

    Louisville, Kentucky, 40205

  • P&I Clinical Research, LLC

    Lufkin, Texas, 75904

  • Kidney and Hypertension Specialist PLLC

    Manassas, Virginia, 20110

  • Florida Kidney Physicians - Melbourne

    Melbourne, Florida, 32901

  • CARE - Boise Kidney Institute

    Meridian, Idaho, 83642

  • Velocity Clinical Research - Metairie

    Metairie, Louisiana, 70006

  • 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

  • Nephrology Physicians LLC

    Mishawaka, Indiana, 46545

  • Bioluminux Clinical Research

    Naperville, Illinois, 60540

  • The Rogosin Institute

    New York, New York, 10021

  • Nephrology Associates Delaware Kidney (FRENOVA)

    Newark, Delaware, 19713

  • Randomize Now - Midtown

    Newnan, Georgia, 30269

  • Providence Medical Foundation - Orange

    Orange, California, 92868

  • South Carolina Clinical Research, LLC

    Orangeburg, South Carolina, 29118

  • Combined Research Orlando Phase I-IV

    Orlando, Florida, 32807

  • Renal Specialists of Houston

    Pasadena, Texas, 77504

  • BioResearch Partner

    Pembroke Pines, Florida, 33029

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Arizona Kidney Disease and Hypertension Center - Thomas Office

    Phoenix, Arizona, 85016

  • D&H Pompano Research Center

    Pompano Beach, Florida, 33064

  • Hypertension & Nephrology Inc.

    Providence, Rhode Island, 02904

  • National Nephrology Alliance Research

    Riverside, California, 92505

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • Rockford Nephrology Associates

    Rockford, Illinois, 61107

  • UC Davis Health

    Sacramento, California, 95819

  • Utah Kidney Research Institute

    Salt Lake City, Utah, 84115

  • Zuckerberg San Francisco General Hospital and Trauma Center

    San Francisco, California, 94110

  • University of California San Francisco (UCSF)

    San Francisco, California, 94143

  • St. Clair Nephrology Research

    Shelby, Michigan, 48315

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Cordova Research Institute, LLC

    Sweetwater, Florida, 33182

  • Arizona Kidney Disease and Hypertension Center - Tuscon

    Tucson, Arizona, 85741

  • Nephrology and Hypertension Associates, LTD

    Tupelo, Mississippi, 38801

Other trials in United States

China45 sites

  • Beijing Tsinghua Changgung Hospital

    Beijing

  • Peking University First Hos

    Beijing

  • Cangzhou People's Hospital

    Cangzhou

  • The Second Norman Bethune Hospital of Jilin University

    Changchun

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi

  • Sichuan People s Hospital

    Chengdu

  • Bishan Hospital of Chongqing

    Chongqing

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing

  • Dongguan People s Hospital

    Dongguan

  • The First People's Hospital of Foshan

    Foshan

  • Fuyang People's Hospital

    Fuyang

  • Fujian Medical University Union Hospital

    Fuzhou

  • Guangdong Provincial People's Hospital

    Guangzhou

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou

  • Third Affiliated Hospital of Southern Medical University

    Guangzhou

  • Zhujiang Hospital, Southern Medical University

    Guangzhou

  • Affiliated Hospital of Guilin Medical University

    Guilin

  • Guizhou Provincial People's Hospital

    Guiyang

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine

    Hangzhou

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot

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

    Jinan

  • The Second Hospital of Shandong University

    Jinan

  • Linyi People's Hospital

    Linyi

  • The First Affiliate Hospital of Henan University of Science and Technology

    Luoyang

  • The First Affiliated Hospital of Nanchang University

    Nanchang

  • Affiliated Hospital of Nantong University

    Nantong

  • Ningbo No.2 Hospital

    Ningbo

  • The First Affiliated Hospital of Ningbo University

    Ningbo

  • The First Affiliated Hospital of Xian JiaoTong University

    Shaanxi

  • Shanghai General Hospital

    Shanghai

  • Shengjing Hospital of China Medical University

    Shenyang

  • The University of Hong Kong - Shenzhen Hospital

    Shenzhen

  • The Second Hospital of Hebei Medical University

    Shijiazhuang

  • Taian City Central Hospital

    Taian

  • Second Hospital of Shanxi Medical University

    Taiyuan

  • The Second Hospital of Tianjin Medical University

    Tianjin

  • Wuxi People s Hospital

    Wuxi

  • Xuancheng People s Hospital

    Xuancheng

  • Yancheng No. 1 People's Hospital

    Yancheng

  • Affiliated Hospital Yangzhou University

    Yangzhou

  • Yantai YuHuangDing Hospital

    Yantai

  • Yichang central people Hos

    Yichang

  • General Hospital of Ningxia Medical University

    Yinchuan

Other trials in China

Japan29 sites

  • Fujita Health University Hos

    Aichi

  • Hyogo Amagasaki Gen Med Ctr

    Amagasaki

  • Fukuoka University Hospital

    Fukuoka

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka

  • Kanazawa Medical Uni Hospital

    Kahoku

  • Kanazawa University Hospital

    Kanazawa

  • Nara Med University Hos

    Kashihara

  • Kasugai Municipal Hospital

    Kasugai

  • Okayama University Hospital

    Kita-ku

  • Kokura Memorial Hospital

    Kitakyushu-shi

  • Kobe University Hospital

    Kobe

  • Dokkyo Medical University Saitama Medical Center

    Koshigaya

  • Japanese Red Cross Kyoto Daini Hospital

    Kyoto

  • Kyoto University Hospital

    Kyoto

  • University of Miyazaki Hos

    Miyazaki

  • Osaka City General Hospital

    Osaka

  • Osaka General Medical Center

    Osaka

  • Sapporo City General Hospital

    Sapporo

  • Tohoku University Tohoku University Hospital

    Sendai

  • Nihon University Itabashi Hospital

    tabashi City

  • Juntendo Hospital Affiliated to Juntendo University School of Medicine

    Tokyo

  • Juntendo University Nerima Hospital

    Tokyo

  • The Jikei Uni Daisan Hospital

    Tokyo

  • The Jikei University Hospital

    Tokyo

  • Tokyo Med University Hospital

    Tokyo

  • Tokyo Women's Medical University Hospital

    Tokyo

  • YUUAI Medical Center

    Tomigusuku

  • Toyama Prefectural Central Hospital

    Toyama

  • Juntendo Uni Urayasu Hospital

    Urayasu-shi

Other trials in Japan

South Korea22 sites

  • Hallym University Sacred Heart Hospital

    Anyang

  • Seoul National University Hospital

    Cheonan

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan

  • Keimyung University Dongsan Medical Center

    Daegu

  • Kyungpook National University Hospital

    Daegu

  • Konyang University Hospital

    Daejeon

  • Hallym University Chuncheon Sacred Heart Hospital

    Gangwon-do

  • Wonju Severance Christian Hospital

    Gangwon-do

  • NHIS Ilsan Hospital

    Goyang-si

  • Seoul National University Bundang Hospital

    Seongnam-si

  • Asan Medical Center

    Seoul

  • Chung-Ang University Hospital

    Seoul

  • Konkuk University Medical Center

    Seoul

  • Korea University Guro Hospital

    Seoul

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

    Seoul

  • Kyung Hee University Hospital at Gangdong (KUIMS)

    Seoul

  • Samsung Medical Center

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

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

    Seoul

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

    Seoul

  • Ajou University Hospital

    Suwon

  • Yongin Severance Hospital

    Yongin-si

Other trials in South Korea

Brazil18 sites

  • Centro de Pesquisa Clinica do Coracao

    Aracaju

  • Freire Pesquisa Clinica

    Belo Horizonte

  • Hospital Evangelico de Belo Horizonte

    Belo Horizonte

  • Associacao Ampara a Saude

    Brasília

  • HU Hospital Walter Cantidio

    Fortaleza

  • UFG Hospital de Clinicas da Universidad Federal de Golas

    Goiânia

  • Hospital de Caridade de Ijui

    Ijuí

  • Fundacao Pro-Rim Santa Catarina

    Joinville

  • Centro Mineiro de Pesquisa

    Juiz de Fora

  • Hospital das Clinicas Riberao Preto

    Monte Alegre

  • Hospital das Clinicas da Universidade Federal de Pernambuco (UFPE)

    Recife

  • Hospital Universitario Pedro Ernesto - UERJ

    Rio de Janeiro

  • Clinica Senhor do Bonfim

    Salvador

  • Universidade Federal da Bahia

    Salvador

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

    São Paulo

  • Hospital do Rim Fundacao Oswaldo Ramos

    São Paulo

  • Hospital Nove de Julho - DASA

    São Paulo

  • A2z Clinical Centro Avancedo de Pesquisa Clinica

    Valinhos

Other trials in Brazil

Australia17 sites

  • Grampians Health Ballarat

    Ballarat

  • Bendigo Hospital

    Bendigo

  • Sunshine Coast University Hospital

    Birtinya

  • Core Research Group Pty Ltd

    Brisbane

  • Royal Prince Alfred Hospital

    Camperdown

  • Monash Health

    Clayton

  • Concord Repatriation General Hospital

    Concord

  • Canberra Hospital

    Garran

  • Renal Research Gosford

    Gosford

  • Austin Hospital

    Heidelberg

  • Western Health (Sunshine Hospital)

    Melbourne

  • Fiona Stanley Hospital

    Murdoch

  • John Hunter Hospital

    Newcastle

  • Sir Charles Gairdner Hospital

    Perth

  • Melbourne Renal Research

    Reservoir

  • Gold Coast University Clinical Trials Unit

    Southport

  • Princess Alexandra Hospital

    Woolloongabba

Other trials in Australia

United Kingdom17 sites

  • Belfast Health and Social Care Trust

    Belfast

  • FutureMeds - Soho Road Health Centre

    Birmingham

  • Southmead Hospital

    Bristol

  • Cambridge University - Addenbrooke's Hospital

    Cambridge

  • FutureMeds - CPS Research

    Glasgow

  • Queen Elizabeth University Hospital - Glasgow

    Glasgow

  • Gloucestershire Royal Hospital

    Gloucester

  • Leicester General Hospital

    Leicester

  • Barts Health NHS Trust

    London

  • Imperial College Healthcare NHS Trust

    London

  • King's College Hospital

    London

  • St Pancras Clinical Research

    London

  • University of Manchester, Manchester Royal Infirmary

    Manchester

  • FutureMeds Newcastle

    Newcastle upon Tyne

  • FutureMeds Tesside

    Stockton-on-Tees

  • FutureMeds Liverpool

    Wirral (Liverpool)

  • Royal Wolverhampton NHS Trust

    Wolverhampton

Other trials in United Kingdom

Spain12 sites

  • Hospital Universitari de Bellvitge

    Barcelona

  • Hospital Universitatio Vall d'Hebron

    Barcelona

  • Hospital Universitario Reina Sofia

    Córdoba

  • Hospital Universitari Arnau de Vilanova - Lleida

    Lleida

  • Clinica Universidad de Navarra - Madrid

    Madrid

  • Hospital Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario Puerta de Hierro

    Madrid

  • Hospital Universitario Ramon y Cajal

    Madrid

  • Clinica Universidad de Navarra - Pamplona

    Pamplona

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela

  • Hospital Universitario Virgen Macarena

    Seville

  • Hospital Universitario Doctor Peset

    Valencia

Other trials in Spain

France9 sites

  • Groupe Hospitalier Pellegrin, CHU De Bordeaux

    Bordeaux

  • Hopitaux Universitaires Henri Mondor

    Créteil

  • Centre Hospitalier Emile Roux

    Le Puy-en-Velay

  • AP-HM - Hopital de La Conception

    Marseille

  • CHU de Nantes - Hotel-Dieu

    Nantes

  • Hopital Necker - Enfants Malades

    Paris

  • Université Paris-Descartes / Hôpital Européen Georges Pompidou

    Paris

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

    Saint-Priest-en-Jarez

  • Centre Hospitalier de Valencienes

    Valenciennes

Other trials in France

Austria5 sites

  • LKH Feldkirch

    Feldkirch

  • Medizinische Universitaet Innsbruck

    Innsbruck

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz

  • Medizinische Universitaet Wien

    Vienna

  • Klinikum Wels- Grieskirchen

    Wels-Grieskirchen

Other trials in Austria

Germany5 sites

  • Medizinische Klinik II

    Aachen

  • Charite Universitaetsnedizin Berlin

    Berlin

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden

  • Klinikum St Georg

    Leipzig

  • Universitaetsklinikum Leipzig

    Leipzig

Other trials in Germany

Italy5 sites

  • Azienda Ospedaliera Universitaria Consorziale - policlinicio Bari

    Bari

  • Ospedale Policlinico San Martino IRCCS

    Genova

  • AOU Policlinico di Modena

    Modena

  • Istituti Clinici Scientifici Maugeri-IRCCS Pavia

    Pavia

  • Fondazione Policlinico Universitario A. Gemelli

    Rome

Other trials in Italy

Poland5 sites

  • SCM Sp. Z o.o

    Krakow

  • Klinika Nefrologii, Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi

    Lodzkie

  • Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie

    Szczecin

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

    Warsaw

  • Velocity Zamosc

    Zamość

Other trials in Poland

Sweden5 sites

  • Nephrology Clinic, Danderyd University Hospital

    Danderyd

  • Sahlgrenska University Hospital

    Gothenburg

  • Karolinska University Hospital Huddinge

    Huddinge

  • Linkoping University Hospital

    Linköping

  • Uppsala University Hospital

    Uppsala

Other trials in Sweden

Taiwan5 sites

  • Shuang Ho Hospital

    New Taipei City

  • Tungs' Taichung Metroharbour Hospital

    Taichung

  • National Taiwan University Hospital (NTUH)

    Taipei

  • Taipei Medical University Hospital

    Taipei

  • Taipei Veterans General Hospital (TP-VGH)

    Taipei

Other trials in Taiwan

Denmark4 sites

  • Aalborg University Hospital

    Aalborg

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

    Copenhagen

  • Hillerod Hospital

    Hillerød

  • Sygehus Lillebaelt - Kolding

    Kolding

Other trials in Denmark

Ireland4 sites

  • Cork University Hospital

    Cork

  • Beaumont Hospital

    Dublin

  • University Hospital Galway

    Galway

  • University Hospital Waterford

    Waterford

Other trials in Ireland

Israel4 sites

  • Barzilai Medical Center

    Ashkelon

  • Rabin Medical Center

    Petah Tivka

  • Sheba Medical Center

    Tel HaShomer

  • Shamir Medical Center

    Tsrifin

Other trials in Israel

Croatia3 sites

  • Clinical Hospital Dubrava

    Zagreb

  • Clinical Hospital Merkur

    Zagreb

  • Polyclinic Somed

    Zagreb

Other trials in Croatia

Czechia3 sites

  • Fakultni Nemocnice Brno

    Brno

  • Vseobecna fakultni nemocnice v Praze

    New Town

  • Nemocnice AGEL Novy Jicin a.s.

    Nový Jičín

Other trials in Czechia

Hong Kong3 sites

  • Queen Mary Hospital

    Hong Kong

  • Prince Wales Hospital

    Shatin

  • Tung Wah Hospital

    Sheung Wan

Other trials in Hong Kong

Turkey (Türkiye)3 sites

  • Hacettepe University Hospital

    Ankara

  • Istanbul University Cerrahpasa Medical Faculty

    Istanbul

  • Kocaeli University Medical School

    Kocaeli

Other trials in Turkey (Türkiye)

Belgium2 sites

  • Ziekenhuis Oost-Limburg

    Genk

  • Universitaire Ziekenhuizen Leuven

    Leuven

Other trials in Belgium

Estonia2 sites

  • North Estonia Medical Centre Foundation

    Tallinn

  • Tartu University Hospital

    Tartu

Other trials in Estonia

Latvia2 sites

  • Paula Stradina Clinical University Hospital

    Riga

  • Vidzemes Hospital

    Valmiera

Other trials in Latvia

Lithuania2 sites

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

    Kaunas

  • Vilnius University Hospital Santaros Klinikos

    Vilnius

Other trials in Lithuania

Netherlands2 sites

  • University Medical Center Groningen

    Groningen

  • UMC St. Radboud

    Nijmegen

Other trials in Netherlands

Norway2 sites

  • Haukeland University Hospital

    Bergen

  • Oslo University Hospital - Ulleval Hospital

    Oslo

Other trials in Norway

Saudi Arabia2 sites

  • King Fahad Specialist Hospital, Dammam

    Dammam

  • King Saud University, King Saud University Medical City

    Riyadh

Other trials in Saudi Arabia

Canada1 site

  • St. Josephs Healthcare - Hamilton

    Hamilton

Other trials in Canada

Finland1 site

  • Tampere University Hospital

    Tampere

Other trials in Finland

Hungary1 site

  • Pecsi Tudomanyegyetem Klinikai Kozpont

    Pécs

Other trials in Hungary

Mexico1 site

  • Arke SMO SA de CV

    Veracruz

Other trials in Mexico

About this study

Official title: 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.

Being tested
Povetacicept, Placebo (matched to Povetacicept)
Keywords
IgAN, Berger's disease, glomerulonephritis, IgA nephropathy, ALPN-303, BAFF, BLyS, APRIL
Medical subject headings
Glomerulonephritis, IGA, Glomerulonephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PovetaciceptDrug

    Also called ALPN-303

    Subcutaneous injection administration.

  • Placebo (matched to Povetacicept)Drug

    Placebo matched to Povetacicept subcutaneous injection administration.

Study groups in NCT06564142
Study groupRoleWhat they receive
PovetaciceptExperimentalParticipants will be randomized to receive Povetacicept.
Receives: Drug: Povetacicept
PlaceboPlacebo comparatorParticipants will be randomized to receive placebo matched to Povetacicept.
Receives: Drug: Placebo (matched to Povetacicept)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36

    Measured: From Baseline at Week 36

  2. Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104

    Measured: From Baseline Through Week 104

Secondary outcomes (4)

  1. Change from Baseline in Serum Gd-IgA1 at Week 36

    Measured: From Baseline at Week 36

  2. Proportion of Participants to Achieve Hematuria Resolution at Week 36 (Among Participants With Hematuria at Baseline)

    Measured: From Baseline at Week 36

  3. Change From Baseline in eGFR at Week 104

    Measured: From Baseline at Week 104

  4. Time to Kidney Disease Progression 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

    Measured: From Baseline Through Week 104

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2024
  2. Study start30 Aug 2024
  3. Primary completion30 Jan 2028 (estimated)
  4. Study completion30 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
605 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06564142
Sponsor's protocol ID
VX24-AIS-D08
Other IDs
2024-514135-17-00
Status last verified
May 2026
First submitted
19 Aug 2024
Last updated
15 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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/

Publications

  • Barratt J, Zhang H, Han SH, Suzuki Y, Tumlin J, Chacko B, Noronha IL, Madan A, Duivenvoorden R, Azzi JR, Nester C, Dong C, Ahluwalia N, Li J, Bozic C, Egbuna O, Wong MG, Lafayette R; RAINIER AIS-D08 Trial Group. Interim Analysis of a Phase 3 Trial of Povetacicept in IgA Nephropathy. N Engl J Med. 2026 Oct 23. doi: 10.1056/NEJMoa2608682. Online ahead of print.

    PubMed 42912669

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Povetacicept in people with Immunoglobulin A Nephropathy, run by Alpine Immune Sciences Inc, A Subsidiary of Vertex at 318 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 318 sites in United States, China, Japan, South Korea, Brazil and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 (time frame: From Baseline at Week 36). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06564142, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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