A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)
Status: Active_not_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
Huntsville
Arizona
Arizona Kidney Disease and Hypertension Center - Thomas Office
Phoenix
Arizona Kidney Disease and Hypertension Center - Tuscon
Tucson
California
West Coast Kidney
Fremont
The Medical Research Group, Inc. (FRENOVA)
Fresno
CARE Institute - Carabello Kidney
Los Angeles
Providence Medical Foundation - Orange
Orange
National Nephrology Alliance Research
Riverside
UC Davis Health
Sacramento
University of California San Francisco (UCSF)
San Francisco
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco
Colorado
Western Nephrology
Arvada
Colorado Kidney Care
Denver
Delaware
Nephrology Associates Delaware Kidney (FRENOVA)
Newark
Florida
South Florida Nephrology Group PA, Research Div.
Coral Springs
Dolphin Medical Research
Doral
Nephrology Associates of Central Florida
Hollywood
Tectum Medical Research, LLC
Hollywood
South Florida Research Institute
Lauderdale Lakes
Florida Kidney Physicians - Melbourne
Melbourne
Med-Care Research
Miami
Nephrology Associates of South Miami
Miami
On Health Research Center
Miami
Professional Research Center
Miami
Combined Research Orlando Phase I-IV
Orlando
BioResearch Partner
Pembroke Pines
D&H Pompano Research Center
Pompano Beach
Cordova Research Institute, LLC
Sweetwater
Georgia
SciMerge Clinical Research
Atlanta
Georgia Nephrology - Lawrenceville
Lawrenceville
Randomize Now - Midtown
Newnan
Idaho
Care Institute - Chubbuck, ID
Chubbuck
Care Institute - Idaho Falls
Idaho Falls
CARE - Boise Kidney Institute
Meridian
Illinois
Bioluminux Clinical Research
Naperville
Rockford Nephrology Associates
Rockford
Indiana
Nephrology Associates of Northern Illinois and Indiana (NANI)
Indianapolis
Nephrology Physicians LLC
Mishawaka
Kentucky
Nephrology Associates of Kentuckiana
Louisville
Louisiana
Renal Associates of Baton Rouge
Baton Rouge
Velocity Clinical Research - Metairie
Metairie
Maryland
Johns Hopkins School of Medicine
Baltimore
Michigan
St. Clair Nephrology Research
Shelby
Minnesota
InterMed Consultants / DaVita Clinical Research, Edina
Edina
Mayo Clinic - Rochester
Rochester
Missouri
Washington University in St. Louis
St Louis
Mississippi
Nephrology and Hypertension Associates, LTD
Tupelo
North Carolina
Metrolina Nephrology Associates
Charlotte
Nebraska
Somnos Clinical Research
Lincoln
New Jersey
Bioluminux Clinical Research New Jersey
Hamilton
New Jersey Kidney Care, LLC (FRENOVA)
Jersey City
New Mexico
Renal Medicine Associates
Albuquerque
Nevada
DaVita Clinical Research Nevada - Las Vegas
Las Vegas
New York
New York Nephrology Vasculitis and Glomerular Center
Albany
Queens Hospital Center
Jamaica
The Rogosin Institute
New York
Ohio
The Ohio State University Wexner Medical Center
Columbus
Pennsylvania
Thomas Jefferson University
Philadelphia
Rhode Island
Nephrology Associates Inc
East Providence
Hypertension & Nephrology Inc.
Providence
South Carolina
South Carolina Clinical Research, LLC
Orangeburg
Tennessee
Knoxville Kidney Center (KKC), PLLC
Knoxville
Texas
Velocity Clinical Research
Abilene
Introscience Research LLC
Bellaire
Dallas Renal Group
Dallas
Renal Disease Research Institute - Dallas
Dallas
Davita Clinical Research - El Paso
El Paso
Houston Medical Research Institute, LLC (FRENOVA)
Houston
Prolato Clinical Research Center
Houston
R & H Clinical Research
Katy
North Texas Kidney Disease Associates
Lewisville
P&I Clinical Research, LLC
Lufkin
Renal Specialists of Houston
Pasadena
Utah
Utah Kidney Research Institute
Salt Lake City
Virginia
Virginia Nephrology Group
Fairfax
Kidney and Hypertension Specialist PLLC
Manassas
Vermont
University of Vermont
Burlington
Other Locations
Australia
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
Austria
LKH Feldkirch
Feldkirch
Medizinische Universitaet Innsbruck
Innsbruck
Ordensklinikum Linz GmbH Elisabethinen
Linz
Medizinische Universitaet Wien
Vienna
Klinikum Wels- Grieskirchen
Wels-grieskirchen
Belgium
Ziekenhuis Oost-Limburg
Genk
Universitaire Ziekenhuizen Leuven
Leuven
Brazil
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
Canada
St. Josephs Healthcare - Hamilton
Hamilton
China
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
Croatia
Clinical Hospital Dubrava
Zagreb
Clinical Hospital Merkur
Zagreb
Polyclinic Somed
Zagreb
Denmark
Aalborg University Hospital
Aalborg
Center for Cancer and Organ Diseases - Rigshospitalet - Hornum Mads
Copenhagen
Hillerod Hospital
Hillerød
Sygehus Lillebaelt - Kolding
Kolding
Estonia
North Estonia Medical Centre Foundation
Tallinn
Tartu University Hospital
Tartu
Finland
Tampere University Hospital
Tampere
France
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
Germany
Medizinische Klinik II
Aachen
Charite Universitaetsnedizin Berlin
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden
Klinikum St Georg
Leipzig
Universitaetsklinikum Leipzig
Leipzig
Hong Kong Special Administrative Region
Queen Mary Hospital
Hong Kong
Prince Wales Hospital
Shatin
Tung Wah Hospital
Sheung Wan
Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs
Ireland
Cork University Hospital
Cork
Beaumont Hospital
Dublin
University Hospital Galway
Galway
University Hospital Waterford
Waterford
Israel
Barzilai Medical Center
Ashkelon
Rabin Medical Center
Petah Tivka
Sheba Medical Center
Tel Litwinsky
Shamir Medical Center
Ẕerifin
Italy
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
Japan
Fujita Health University Hos
Aichi
Hyogo Amagasaki Gen Med Ctr
Amagasaki
Fukuoka University Hospital
Fukuoka
Japanese Red Cross Fukuoka Hospital
Fukuoka
Nihon University Itabashi Hospital
Itabashi-ku
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
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
Latvia
Paula Stradina Clinical University Hospital
Riga
Vidzemes Hospital
Valmiera
Lithuania
Hospital of Lithuanian University of Health Sciences (LSMU) Kauno klinikos
Kaunas
Vilnius University Hospital Santaros Klinikos
Vilnius
Mexico
Arke SMO SA de CV
Veracruz
Netherlands
University Medical Center Groningen
Groningen
UMC St. Radboud
Nijmegen
Norway
Haukeland University Hospital
Bergen
Oslo University Hospital - Ulleval Hospital
Oslo
Poland
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
Republic of Korea
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
Saudi Arabia
King Fahad Specialist Hospital, Dammam
Dammam
King Saud University, King Saud University Medical City
Riyadh
Spain
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
Sweden
Nephrology Clinic, Danderyd University Hospital
Danderyd
Sahlgrenska University Hospital
Gothenburg
Karolinska University Hospital Huddinge
Huddinge
Linkoping University Hospital
Linköping
Uppsala University Hospital
Uppsala
Taiwan
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
Turkey
Hacettepe University Hospital
Ankara
Istanbul University Cerrahpasa Medical Faculty
Istanbul
Kocaeli University Medical School
Kocaeli
United Kingdom
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
Time Frame
Start Date: 2024-08-30
Completion Date: 2028-01-30
Participants
Target number of participants: 605
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