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Evaluering af Povetacicepts effekt hos voksne med immunglobulin A nefropati (IgAN)

14. maj 2026 opdateret af: Alpine Immune Sciences Inc, A Subsidiary of Vertex

En fase 3, randomiseret, dobbeltblind, placebokontrolleret undersøgelse af Povetacicept hos voksne med immunglobulin A nefropati (RAINIER)

Formålet med denne undersøgelse er at evaluere effekten af ​​povetacicept hos voksne deltagere sammenlignet med placebo til at reducere proteinuri og bevare nyrefunktionen.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

En fase 3, randomiseret, dobbeltblind, placebo-kontrolleret undersøgelse af Povetacicept hos voksne med immunoglobin A-nefropati

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

605

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Nøgleinklusionskriterier:

  • Diagnosticeret IgAN, med biopsibekræftelse inden for 10 år efter screening
  • 24-timers proteinuri-udskillelse ≥1,0 ​​g/dag eller 24-timers uPCR ≥0,75 g/g
  • Estimeret glomerulær filtrationshastighed (eGFR) ≥ 30 ml/min/1
  • Stabil angiotensinkonverterende enzymhæmmer (ACEi) eller angiotensin II-receptorblokker (ARB'er) i henhold til protokolspecifikation

Nøgleekskluderingskriterier:

  • Har modtaget nogen immunsuppressiv behandling eller procedurer (inklusive kortikosteroider, orale immunsuppressive midler, B-celle- eller plasmacelle-målrettede terapier, supplerende målrettede terapier, naturlægemidler pr. protokol og tonsillektomi) inden for en udvaskningsperiode pr. protokol
  • Hurtigt progressiv glomerulonefritis med eGFR-reduktion >50 % inden for 12 uger efter start af screening

Andre protokoldefinerede Inklusions-/Eksklusionskriterier kan være gældende.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Povetacicept
Deltagerne vil blive randomiseret til at modtage Povetacicept.
Medicin: Povetacicept
Administration af subkutan injektion.
Andre navne:
  • ALPN-303
Placebo komparator: Placebo
Deltagerne vil blive randomiseret til at modtage placebo matchet med Povetacicept.
Medicin: Placebo (matchet med Povetacicept)
Placebo matchede med Povetacicept subkutan injektion.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Ændring fra baseline i 24-timers urinprotein til kreatininforhold (uPCR) i uge 36
Tidsramme: Fra baseline i uge 36
Fra baseline i uge 36
Samlet estimeret glomerulær filtrationshastighed (eGFR) hældning gennem uge 104
Tidsramme: Fra baseline til uge 104
Fra baseline til uge 104

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ændring fra baseline i eGFR i uge 104
Tidsramme: Fra baseline i uge 104
Fra baseline i uge 104
Ændring fra baseline i serum Gd-IgA1 i uge 36
Tidsramme: Fra baseline ved uge 36
Fra baseline ved uge 36
Andel af deltagere, der opnår hematuriresolution ved uge 36 (blandt deltagere med hematuri ved baseline)
Tidsramme: Fra baseline ved uge 36
Fra baseline ved uge 36
Tid til progression af nyresygdom gennem uge 104
Tidsramme: Fra baseline gennem uge 104
Nyreprogression defineret som et fald i eGFR på mere end eller lig med (≥) 30 %, terminal nyresvigt eller ikke-accidentel død
Fra baseline gennem uge 104

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Alpine Immune Sciences Inc, A Subsidiary of Vertex

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. august 2024

Primær færdiggørelse (Anslået)

30. januar 2028

Studieafslutning (Anslået)

30. januar 2028

Datoer for studieregistrering

Først indsendt

19. august 2024

Først indsendt, der opfyldte QC-kriterier

19. august 2024

Først opslået (Faktiske)

21. august 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VX24-AIS-D08
  • 2024-514135-17-00 (Anden identifikator: EU CT number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Detaljer om Vertex datadelingskriterier og proces for at anmode om adgang kan findes på: https://www.vrtx.com/independent-research/clinical-trial-data-sharing

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner