A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)
Status: Recruiting
Location: See all (315) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Apogee Clinical Research, LLC
RECRUITING
Huntsville
Arizona
Arizona Kidney Disease and Hypertension Center - Thomas Office
RECRUITING
Phoenix
Arizona Kidney Disease and Hypertension Center - Tuscon
RECRUITING
Tucson
California
West Coast Kidney
RECRUITING
Fremont
The Medical Research Group, Inc. (FRENOVA)
RECRUITING
Fresno
CARE Institute - Carabello Kidney
RECRUITING
Los Angeles
Providence Medical Foundation - Orange
RECRUITING
Orange
National Nephrology Alliance Research
RECRUITING
Riverside
UC Davis Health
RECRUITING
Sacramento
University of California San Francisco (UCSF)
RECRUITING
San Francisco
Zuckerberg San Francisco General Hospital and Trauma Center
RECRUITING
San Francisco
Colorado
Western Nephrology
RECRUITING
Arvada
Colorado Kidney Care
RECRUITING
Denver
Delaware
Nephrology Associates Delaware Kidney (FRENOVA)
ACTIVE_NOT_RECRUITING
Newark
Florida
South Florida Nephrology Group PA, Research Div.
RECRUITING
Coral Springs
Dolphin Medical Research
RECRUITING
Doral
Nephrology Associates of Central Florida
RECRUITING
Hollywood
Tectum Medical Research, LLC
RECRUITING
Hollywood
South Florida Research Institute
RECRUITING
Lauderdale Lakes
Florida Kidney Physicians - Melbourne
RECRUITING
Melbourne
Med-Care Research
RECRUITING
Miami
Nephrology Associates of South Miami
RECRUITING
Miami
On Health Research Center
RECRUITING
Miami
Professional Research Center
RECRUITING
Miami
Combined Research Orlando Phase I-IV
RECRUITING
Orlando
BioResearch Partner
RECRUITING
Pembroke Pines
D&H Pompano Research Center
RECRUITING
Pompano Beach
Cordova Research Institute, LLC
RECRUITING
Sweetwater
Georgia
SciMerge Clinical Research
RECRUITING
Atlanta
Georgia Nephrology - Lawrenceville
RECRUITING
Lawrenceville
Randomize Now - Midtown
RECRUITING
Newnan
Idaho
Care Institute - Chubbuck, ID
RECRUITING
Chubbuck
Care Institute - Idaho Falls
RECRUITING
Idaho Falls
CARE - Boise Kidney Institute
RECRUITING
Meridian
Illinois
Bioluminux Clinical Research
RECRUITING
Naperville
Rockford Nephrology Associates
RECRUITING
Rockford
Indiana
Nephrology Associates of Northern Illinois and Indiana (NANI)
RECRUITING
Indianapolis
Nephrology Physicians LLC
RECRUITING
Mishawaka
Kentucky
Nephrology Associates of Kentuckiana
RECRUITING
Louisville
Louisiana
Renal Associates of Baton Rouge
RECRUITING
Baton Rouge
Velocity Clinical Research - Metairie
RECRUITING
Metairie
Maryland
Johns Hopkins School of Medicine
RECRUITING
Baltimore
Michigan
St. Clair Nephrology Research
RECRUITING
Shelby
Minnesota
InterMed Consultants / DaVita Clinical Research, Edina
RECRUITING
Edina
Mayo Clinic - Rochester
RECRUITING
Rochester
Missouri
Washington University in St. Louis
RECRUITING
St Louis
Mississippi
Nephrology and Hypertension Associates, LTD
RECRUITING
Tupelo
North Carolina
Metrolina Nephrology Associates
RECRUITING
Charlotte
Nebraska
Somnos Clinical Research
RECRUITING
Lincoln
New Jersey
Bioluminux Clinical Research New Jersey
RECRUITING
Hamilton
New Jersey Kidney Care, LLC (FRENOVA)
RECRUITING
Jersey City
New Mexico
Renal Medicine Associates
RECRUITING
Albuquerque
Nevada
DaVita Clinical Research Nevada - Las Vegas
RECRUITING
Las Vegas
New York
New York Nephrology Vasculitis and Glomerular Center
RECRUITING
Albany
Queens Hospital Center
RECRUITING
Jamaica
The Rogosin Institute
RECRUITING
New York
Ohio
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Pennsylvania
Thomas Jefferson University
RECRUITING
Philadelphia
Rhode Island
Nephrology Associates Inc
RECRUITING
East Providence
Hypertension & Nephrology Inc.
RECRUITING
Providence
South Carolina
South Carolina Clinical Research, LLC
ACTIVE_NOT_RECRUITING
Orangeburg
Tennessee
Knoxville Kidney Center (KKC), PLLC
RECRUITING
Knoxville
Texas
Velocity Clinical Research
ACTIVE_NOT_RECRUITING
Abilene
Introscience Research LLC
RECRUITING
Bellaire
Dallas Renal Group
RECRUITING
Dallas
Renal Disease Research Institute - Dallas
RECRUITING
Dallas
Davita Clinical Research - El Paso
RECRUITING
El Paso
Houston Medical Research Institute, LLC (FRENOVA)
RECRUITING
Houston
Prolato Clinical Research Center
RECRUITING
Houston
R & H Clinical Research
RECRUITING
Katy
North Texas Kidney Disease Associates
RECRUITING
Lewisville
P&I Clinical Research, LLC
RECRUITING
Lufkin
Renal Specialists of Houston
RECRUITING
Pasadena
Utah
Utah Kidney Research Institute
RECRUITING
Salt Lake City
Virginia
Virginia Nephrology Group
RECRUITING
Fairfax
Kidney and Hypertension Specialist PLLC
RECRUITING
Manassas
Vermont
University of Vermont
RECRUITING
Burlington
Other Locations
Australia
Grampians Health Ballarat
RECRUITING
Ballarat
Bendigo Hospital
RECRUITING
Bendigo
Sunshine Coast University Hospital
RECRUITING
Birtinya
Core Research Group Pty Ltd
RECRUITING
Brisbane
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Monash Health
RECRUITING
Clayton
Concord Repatriation General Hospital
RECRUITING
Concord
Canberra Hospital
RECRUITING
Garran
Renal Research Gosford
RECRUITING
Gosford
Austin Hospital
RECRUITING
Heidelberg
Western Health (Sunshine Hospital)
RECRUITING
Melbourne
Fiona Stanley Hospital
RECRUITING
Murdoch
John Hunter Hospital
RECRUITING
Newcastle
Sir Charles Gairdner Hospital
RECRUITING
Perth
Melbourne Renal Research
RECRUITING
Reservoir
Gold Coast University Clinical Trials Unit
RECRUITING
Southport
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
LKH Feldkirch
RECRUITING
Feldkirch
Medizinische Universitaet Innsbruck
RECRUITING
Innsbruck
Ordensklinikum Linz GmbH Elisabethinen
RECRUITING
Linz
Medizinische Universitaet Wien
RECRUITING
Vienna
Klinikum Wels- Grieskirchen
RECRUITING
Wels-grieskirchen
Belgium
Ziekenhuis Oost-Limburg
RECRUITING
Genk
Universitaire Ziekenhuizen Leuven
RECRUITING
Leuven
Brazil
Centro de Pesquisa Clinica do Coracao
RECRUITING
Aracaju
Freire Pesquisa Clinica
RECRUITING
Belo Horizonte
Hospital Evangelico de Belo Horizonte
ACTIVE_NOT_RECRUITING
Belo Horizonte
Associacao Ampara a Saude
RECRUITING
Brasília
HU Hospital Walter Cantidio
RECRUITING
Fortaleza
UFG Hospital de Clinicas da Universidad Federal de Golas
RECRUITING
Goiânia
Hospital de Caridade de Ijui
RECRUITING
Ijuí
Fundacao Pro-Rim Santa Catarina
RECRUITING
Joinville
Centro Mineiro de Pesquisa
RECRUITING
Juiz De Fora
Hospital das Clinicas Riberao Preto
RECRUITING
Monte Alegre
Hospital das Clinicas da Universidade Federal de Pernambuco (UFPE)
RECRUITING
Recife
Hospital Universitario Pedro Ernesto - UERJ
RECRUITING
Rio De Janeiro
Clinica Senhor do Bonfim
ACTIVE_NOT_RECRUITING
Salvador
Universidade Federal da Bahia
RECRUITING
Salvador
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
RECRUITING
São Paulo
Hospital do Rim Fundacao Oswaldo Ramos
RECRUITING
São Paulo
Hospital Nove de Julho - DASA
RECRUITING
São Paulo
A2z Clinical Centro Avancedo de Pesquisa Clinica
RECRUITING
Valinhos
Canada
St. Josephs Healthcare - Hamilton
RECRUITING
Hamilton
China
Beijing Tsinghua Changgung Hospital
RECRUITING
Beijing
Peking University First Hos
RECRUITING
Beijing
Cangzhou People's Hospital
RECRUITING
Cangzhou
The Second Norman Bethune Hospital of Jilin University
RECRUITING
Changchun
Heping Hospital Affiliated to Changzhi Medical College
RECRUITING
Changzhi
Sichuan People s Hospital
RECRUITING
Chengdu
Bishan Hospital of Chongqing
RECRUITING
Chongqing
The Second Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Dongguan People s Hospital
RECRUITING
Dongguan
The First People's Hospital of Foshan
RECRUITING
Foshan
Fuyang People's Hospital
RECRUITING
Fuyang
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
The First Affiliated Hospital of Guangzhou Medical University
RECRUITING
Guangzhou
Third Affiliated Hospital of Southern Medical University
RECRUITING
Guangzhou
Zhujiang Hospital, Southern Medical University
RECRUITING
Guangzhou
Affiliated Hospital of Guilin Medical University
RECRUITING
Guilin
Guizhou Provincial People's Hospital
RECRUITING
Guiyang
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The Second Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
The Affiliated Hospital of Inner Mongolia Medical University
RECRUITING
Hohhot
The First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital)
RECRUITING
Jinan
The Second Hospital of Shandong University
RECRUITING
Jinan
Linyi People's Hospital
RECRUITING
Linyi
The First Affiliate Hospital of Henan University of Science and Technology
RECRUITING
Luoyang
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Ningbo No.2 Hospital
RECRUITING
Ningbo
The First Affiliated Hospital of Ningbo University
RECRUITING
Ningbo
The First Affiliated Hospital of Xian JiaoTong University
RECRUITING
Shaanxi
Shanghai General Hospital
RECRUITING
Shanghai
Shengjing Hospital of China Medical University
RECRUITING
Shenyang
The University of Hong Kong - Shenzhen Hospital
RECRUITING
Shenzhen
The Second Hospital of Hebei Medical University
RECRUITING
Shijiazhuang
Taian City Central Hospital
RECRUITING
Taian
Second Hospital of Shanxi Medical University
RECRUITING
Taiyuan
The Second Hospital of Tianjin Medical University
RECRUITING
Tianjin
Wuxi People s Hospital
RECRUITING
Wuxi
Xuancheng People s Hospital
RECRUITING
Xuancheng
Yancheng No. 1 People's Hospital
RECRUITING
Yancheng
Affiliated Hospital Yangzhou University
RECRUITING
Yangzhou
Yantai YuHuangDing Hospital
RECRUITING
Yantai
Yichang central people Hos
RECRUITING
Yichang
General Hospital of Ningxia Medical University
RECRUITING
Yinchuan
Croatia
Clinical Hospital Dubrava
RECRUITING
Zagreb
Clinical Hospital Merkur
RECRUITING
Zagreb
Polyclinic Somed
RECRUITING
Zagreb
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Center for Cancer and Organ Diseases - Rigshospitalet - Hornum Mads
RECRUITING
Copenhagen
Hillerod Hospital
RECRUITING
Hillerød
Sygehus Lillebaelt - Kolding
RECRUITING
Kolding
Estonia
North Estonia Medical Centre Foundation
RECRUITING
Tallinn
Tartu University Hospital
RECRUITING
Tartu
Finland
Tampere University Hospital
RECRUITING
Tampere
France
Groupe Hospitalier Pellegrin, CHU De Bordeaux
RECRUITING
Bordeaux
Hopitaux Universitaires Henri Mondor
RECRUITING
Créteil
Centre Hospitalier Emile Roux
RECRUITING
Le Puy-en-velay
AP-HM - Hopital de La Conception
RECRUITING
Marseille
CHU de Nantes - Hotel-Dieu
RECRUITING
Nantes
Hopital Necker - Enfants Malades
RECRUITING
Paris
Université Paris-Descartes / Hôpital Européen Georges Pompidou
RECRUITING
Paris
Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord
RECRUITING
Saint-priest-en-jarez
Centre Hospitalier de Valencienes
RECRUITING
Valenciennes
Germany
Medizinische Klinik II
RECRUITING
Aachen
Charite Universitaetsnedizin Berlin
RECRUITING
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden
RECRUITING
Dresden
Klinikum St Georg
RECRUITING
Leipzig
Universitaetsklinikum Leipzig
RECRUITING
Leipzig
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Prince Wales Hospital
RECRUITING
Shatin
Tung Wah Hospital
RECRUITING
Sheung Wan
Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
RECRUITING
Pécs
Ireland
Cork University Hospital
RECRUITING
Cork
Beaumont Hospital
RECRUITING
Dublin
University Hospital Galway
RECRUITING
Galway
University Hospital Waterford
RECRUITING
Waterford
Israel
Barzilai Medical Center
RECRUITING
Ashkelon
Rabin Medical Center
RECRUITING
Petah Tivka
Sheba Medical Center
RECRUITING
Tel Litwinsky
Shamir Medical Center
RECRUITING
Ẕerifin
Italy
Azienda Ospedaliera Universitaria Consorziale - policlinicio Bari
RECRUITING
Bari
Ospedale Policlinico San Martino IRCCS
RECRUITING
Genova
AOU Policlinico di Modena
RECRUITING
Modena
Istituti Clinici Scientifici Maugeri-IRCCS Pavia
RECRUITING
Pavia
Fondazione Policlinico Universitario A. Gemelli
RECRUITING
Rome
Japan
Fujita Health University Hos
RECRUITING
Aichi
Hyogo Amagasaki Gen Med Ctr
RECRUITING
Amagasaki
Fukuoka University Hospital
RECRUITING
Fukuoka
Japanese Red Cross Fukuoka Hospital
RECRUITING
Fukuoka
Nihon University Itabashi Hospital
RECRUITING
Itabashi-ku
Kanazawa Medical Uni Hospital
RECRUITING
Kahoku
Kanazawa University Hospital
RECRUITING
Kanazawa
Nara Med University Hos
RECRUITING
Kashihara
Kasugai Municipal Hospital
RECRUITING
Kasugai
Okayama University Hospital
RECRUITING
Kita-ku
Kokura Memorial Hospital
RECRUITING
Kitakyushu-shi
Kobe University Hospital
RECRUITING
Kobe
Dokkyo Medical University Saitama Medical Center
RECRUITING
Koshigaya
Japanese Red Cross Kyoto Daini Hospital
RECRUITING
Kyoto
Kyoto University Hospital
RECRUITING
Kyoto
University of Miyazaki Hos
RECRUITING
Miyazaki
Osaka City General Hospital
RECRUITING
Osaka
Osaka General Medical Center
RECRUITING
Osaka
Sapporo City General Hospital
RECRUITING
Sapporo
Tohoku University Tohoku University Hospital
RECRUITING
Sendai
Juntendo Hospital Affiliated to Juntendo University School of Medicine
RECRUITING
Tokyo
Juntendo University Nerima Hospital
RECRUITING
Tokyo
The Jikei Uni Daisan Hospital
RECRUITING
Tokyo
The Jikei University Hospital
RECRUITING
Tokyo
Tokyo Med University Hospital
RECRUITING
Tokyo
Tokyo Women's Medical University Hospital
RECRUITING
Tokyo
YUUAI Medical Center
RECRUITING
Tomigusuku
Toyama Prefectural Central Hospital
RECRUITING
Toyama
Juntendo Uni Urayasu Hospital
RECRUITING
Urayasu-shi
Latvia
Paula Stradina Clinical University Hospital
RECRUITING
Riga
Vidzemes Hospital
RECRUITING
Valmiera
Lithuania
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
RECRUITING
Kaunas
Vilnius University Hospital Santaros Klinikos
RECRUITING
Vilnius
Mexico
Arke SMO SA de CV
ACTIVE_NOT_RECRUITING
Veracruz
Netherlands
University Medical Center Groningen
RECRUITING
Groningen
UMC St. Radboud
RECRUITING
Nijmegen
Norway
Haukeland University Hospital
RECRUITING
Bergen
Oslo University Hospital - Ulleval Hospital
RECRUITING
Oslo
Poland
SCM Sp. Z o.o
RECRUITING
Krakow
Klinika Nefrologii, Centralny Szpital Kliniczny Uniwersytetu Medycznego w Łodzi
RECRUITING
Lodzkie
Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie
RECRUITING
Szczecin
Panstwowy Instytut Medyczny MSWiA - Klinika Chorob Wewnetrznych, Nefrologii i Transplantologii
RECRUITING
Warsaw
Velocity Zamosc
RECRUITING
Zamość
Republic of Korea
Hallym University Sacred Heart Hospital
RECRUITING
Anyang
Seoul National University Hospital
RECRUITING
Cheonan
Soon Chun Hyang University Cheonan Hospital
RECRUITING
Cheonan
Keimyung University Dongsan Medical Center
RECRUITING
Daegu
Kyungpook National University Hospital
RECRUITING
Daegu
Konyang University Hospital
RECRUITING
Daejeon
Hallym University Chuncheon Sacred Heart Hospital
RECRUITING
Gangwon-do
Wonju Severance Christian Hospital
RECRUITING
Gangwon-do
NHIS Ilsan Hospital
RECRUITING
Goyang-si
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Chung-Ang University Hospital
RECRUITING
Seoul
Konkuk University Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Korea University Medical Center (KUMC)-Korea University Anam Hospital
RECRUITING
Seoul
Kyung Hee University Hospital at Gangdong (KUIMS)
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic University of Korea Eunpyeong St. Mary's Hospital
RECRUITING
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Yongin Severance Hospital
RECRUITING
Yongin-si
Saudi Arabia
King Fahad Specialist Hospital, Dammam
RECRUITING
Dammam
King Saud University, King Saud University Medical City
RECRUITING
Riyadh
Spain
Hospital Universitari de Bellvitge
RECRUITING
Barcelona
Hospital Universitatio Vall d'Hebron
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
Hospital Universitari Arnau de Vilanova - Lleida
RECRUITING
Lleida
Clinica Universidad de Navarra - Madrid
RECRUITING
Madrid
Hospital Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
RECRUITING
Madrid
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Clinica Universidad de Navarra - Pamplona
RECRUITING
Pamplona
Hospital Clinico Universitario de Santiago
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitario Doctor Peset
RECRUITING
Valencia
Sweden
Nephrology Clinic, Danderyd University Hospital
RECRUITING
Danderyd
Sahlgrenska University Hospital
RECRUITING
Gothenburg
Karolinska University Hospital Huddinge
RECRUITING
Huddinge
Linkoping University Hospital
RECRUITING
Linköping
Uppsala University Hospital
RECRUITING
Uppsala
Taiwan
Shuang Ho Hospital
RECRUITING
New Taipei City
Tungs' Taichung Metroharbour Hospital
RECRUITING
Taichung
National Taiwan University Hospital (NTUH)
RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital (TP-VGH)
RECRUITING
Taipei
Turkey
Hacettepe University Hospital
RECRUITING
Ankara
Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Istanbul
Kocaeli University Medical School
RECRUITING
Kocaeli
United Kingdom
Belfast Health and Social Care Trust
RECRUITING
Belfast
FutureMeds - Soho Road Health Centre
RECRUITING
Birmingham
Southmead Hospital
RECRUITING
Bristol
Cambridge University - Addenbrooke's Hospital
RECRUITING
Cambridge
FutureMeds - CPS Research
RECRUITING
Glasgow
Queen Elizabeth University Hospital - Glasgow
RECRUITING
Glasgow
Gloucestershire Royal Hospital
RECRUITING
Gloucester
Leicester General Hospital
RECRUITING
Leicester
Barts Health NHS Trust
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
King's College Hospital
RECRUITING
London
St Pancras Clinical Research
RECRUITING
London
University of Manchester, Manchester Royal Infirmary
RECRUITING
Manchester
FutureMeds Newcastle
RECRUITING
Newcastle Upon Tyne
FutureMeds Tesside
RECRUITING
Stockton-on-tees
FutureMeds Liverpool
RECRUITING
Wirral (liverpool)
Royal Wolverhampton NHS Trust
RECRUITING
Wolverhampton
Contact Information
Primary
Medical Information
medicalinfo@vrtx.com
617-341-6777
Time Frame
Start Date: 2024-08-30
Estimated Completion Date: 2028-09-30
Participants
Target number of participants: 480
Treatments
Experimental: Povetacicept
Participants will be randomized to receive Povetacicept.
Placebo_comparator: Placebo
Participants will be randomized to receive placebo matched to Povetacicept.
Related Therapeutic Areas
Sponsors
Leads: Alpine Immune Sciences Inc, A Subsidiary of Vertex