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En studie for å lære om effekten av Felzartamab -infusjoner på voksne med immunoglobulin A nefropati (Igan) (PREVAIL)

13. oktober 2026 oppdatert av: Biogen

En fase 3, randomisert, dobbeltblind, placebokontrollert studie av Felzartamab hos voksne med IgA-nefropati (Prevail)

In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). IgAN is a kidney disease caused by the buildup of an antibody called IgA in the kidneys over time. In people with IgAN, abnormal IgA and other antibodies form clusters that build up in the small filters of the kidneys, which leads to inflammation and damage. Felzartamab is designed to target certain immune cells that produce these abnormal antibodies. This study will focus on participants who have protein in their urine (proteinuria) as a result of damaged kidneys.

The main goal of the study is to learn about the effect felzartamab has on proteinuria. The main question that researchers want to answer is:

• How much does the amount of protein in the urine change from the start of the study to Week 36?

Researchers will learn about the effect felzartamab has on the kidneys' ability to filter blood. They will also learn more about the safety of felzartamab and how it is processed by the body.

The study will be done as follows:

Participants will be screened to check if they can join the study.
Participants will be randomized to receive either felzartamab or a placebo. A placebo looks like the study drug but contains no real medicine.
Neither the researchers nor the participants will know what the participants will receive.
Participants will receive felzartamab or placebo as intravenous (IV) infusions. The treatment period will last 24 weeks.
Afterwards, participants will enter a follow-up period which will last 80 weeks.
In total, participants will have 17 study visits. Participants will stay in the study for about 2 years.

Studieoversikt

Status

Rekruttering

Forhold

Immunoglobulin A nefropati (Igan)

Intervensjon / Behandling

Detaljert beskrivelse

The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on proteinuria in participants with Immunoglobulin A nephropathy (IgAN). The main secondary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on kidney functions in participants with IgAN. The additional secondary objectives are to evaluate the efficacy of felzartamab compared to placebo on additional clinical endpoints and to assess the pharmacokinetics (PK) and immunogenicity of felzartamab.

Studietype

Intervensjonell

Registrering (Antatt)

454

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: US Biogen Clinical Trial Center
Telefonnummer: 866-633-4636
E-post: clinicaltrials@biogen.com

Studer Kontakt Backup

Navn: Global Biogen Clinical Trial Center
E-post: clinicaltrials@biogen.com

Studiesteder

Argentina
- - Buenos Aires, Argentina, C1111AAH
    - Rekruttering
    - DOM Centro de Reumatología
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      Telefonnummer: + 54 91140613734
    - Hovedetterforsker:
      
      Laurencia Korman Turk
  - Buenos Aires, Argentina, B1605
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    - Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
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      Telefonnummer: +54 91161732079
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      Juan Aurelio De Francesco
  - Buenos Aires, Argentina, C1425
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    - Maffei Centro Médico
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      Telefonnummer: 541148019001
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      Maria Smuclir Quevedo
  - Santa Fe, Argentina, 3000
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    - Clínica de Nefrología Urología Y Enfermedades Cardiovasculares
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      Telefonnummer: 543424000000
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      Mariano Arriola
- Buenos Aires F.D.
  - La Boca, Buenos Aires F.D., Argentina, C1155AHD
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    - Hospital General de Agudos Dr. Cosme Argerich
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      Telefonnummer: 5491131997602
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      Raño, Julieta
- Ciudad Autónoma de BuenosAires
  - Almagro, Ciudad Autónoma de BuenosAires, Argentina, C1199ABB
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    - Hospital Italiano de Buenos Aires
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      Carlos Varela
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      Telefonnummer: 541149590200
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, 2000
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      Dana Miralles
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- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, T4000CBC
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      Telefonnummer: +54 381 257-7481
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      Javier Santiago Alonso
Australia
- New South Wales
  - New Lambton, New South Wales, Australia, 2305
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    - John Hunter Hospital
  - New South Wales, New South Wales, Australia, 2060
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    - Concord Repatriation General Hospital
  - St Leonards, New South Wales, Australia, 2065
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    - Royal North Shore Hospital-Reserve Road
  - Westmead, New South Wales, Australia, 2145
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    - Westmead Hospital
- Queensland
  - Douglas, Queensland, Australia, 4814
    - Rekruttering
    - Townsville Hospital
  - Herston, Queensland, Australia, 4029
    - Rekruttering
    - Royal Brisbane & Women's Hospital
  - Southport, Queensland, Australia, 4215
    - Rekruttering
    - Gold Coast University Hospital
  - Southport, Queensland, Australia, 4222
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    - Griffith University
  - Woolloongabba, Queensland, Australia, 4102
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    - Princess Alexandra Hospital
- Victoria
  - St Albans, Victoria, Australia, 3021
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    - Sunshine Hospital - Australia
Belgia
- - Brussels, Belgia, 1200
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    - Cliniques Universitaires Saint-Luc
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      Nathalie Demoulin
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      Telefonnummer: 3227647992
- Brussels Capital
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      Telefonnummer: 3225556896
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      Tess Van Meerhaeghe
- Limburg
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      Ben Sprangers
- Vlaams Brabant
  - Leuven, Vlaams Brabant, Belgia, 3000
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      Kathleen Claes
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      Telefonnummer: 3216345675
- West-Vlaanderen
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    - Jan Yperman
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      Wim Terryn
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  - Kortrijk, West-Vlaanderen, Belgia, 8500
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      Peter Doubel
Brasil
- - São Paulo, Brasil, 05403-000
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      Irene Noronha
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  - São Paulo, Brasil, 01323-903
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    - Hospital Alemao Oswaldo Cruz- HAOC
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      Telefonnummer: 551135490449
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      Victor Sato
- Minas Gerais
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      Pedro Macedo de Souz
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      Rosangela Do Carmo Milagres
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      Barros de Carmo
- Rio Grande do Sul
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      Luciano Da Silva Selistre
  - Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
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Bulgaria
- - Lovech, Bulgaria, 5500
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      Telefonnummer: 359889664169
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      Diana Vasileva
  - Montana, Bulgaria, 3400
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      Irena Dimitrova
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  - Pleven, Bulgaria, 5800
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      Lazar Garev
  - Sofia, Bulgaria, 1606
    - Rekruttering
    - University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD-15 Acad. Ivan Geshov Blvd
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      Telefonnummer: 359887802220
    - Hovedetterforsker:
      
      Atanas Kundurdjiev
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V6Z 1Y6
    - Rekruttering
    - St Paul's Hospital
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      Sean Barbour
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      Telefonnummer: 6046822344
- Quebec
  - Montreal, Quebec, Canada, H4A3J1
    - Rekruttering
    - McGill University Health Centre (MUHC)
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      Telefonnummer: 35207 5149341934
    - Hovedetterforsker:
      
      Rita Suri
Colombia
- Atlántico
  - Barranquilla, Atlántico, Colombia, 80020
    - Rekruttering
    - Clinica de la Costa S.A.S. - PPDS
- Bogota D.C.
  - Bogotá, Bogota D.C., Colombia, 110231
    - Rekruttering
    - Fundacion Santa Fe de Bogota - Calle 119 A No. 7 - 49
- Cundinamarca
  - Bogotá, Cundinamarca, Colombia, 110231
    - Rekruttering
    - Hospital Universitario San Ignacio
  - Zipaquirá, Cundinamarca, Colombia, 250252
    - Rekruttering
    - Healthy Medical Center S.A.S.
- Valle del Cauca Department
  - Cali, Valle del Cauca Department, Colombia, 760032
    - Rekruttering
    - Fundacion Valle Del Lili
Filippinene
- Cebu
  - Cebu City, Cebu, Filippinene, 6000
    - Rekruttering
    - Norzel Medical and Diagnostic Clinic Foundation Corp.
- Metropolitan Manila
  - Pasig, Metropolitan Manila, Filippinene, 1604
    - Rekruttering
    - The Medical City - Ortigas Ave - PPDS
Forente stater
- Arkansas
  - Little Rock, Arkansas, Forente stater, 72205
    - Rekruttering
    - Applied Research Center of Arkansas
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      Telefonnummer: 501-804-5939
    - Hovedetterforsker:
      
      John Heifner
- California
  - Apple Valley, California, Forente stater, 92307
    - Rekruttering
    - Kidney & Hypertension Center - Apple Valley
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      Telefonnummer: 760-780-4179
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      Edgard Vera Tapia
  - Carlsbad, California, Forente stater, 92009
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    - Scripps Green Hospital
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      Telefonnummer: 617-956-2587
    - Hovedetterforsker:
      
      Kimberly Harper
  - Garden Grove, California, Forente stater, 92844-2751
    - Tilbaketrukket
    - National Institute of clinical Research Administration Office
  - Los Angeles, California, Forente stater, 90095
    - Rekruttering
    - UCLA Health David Geffen School of Medicine
    - Hovedetterforsker:
      
      Anjay Rastogi
    - Ta kontakt med:
      
      Telefonnummer: 310-206-8478
  - Oxnard, California, Forente stater, 93030
    - Rekruttering
    - FOMAT Medical Research - FOMAT - PPDS
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      Telefonnummer: 805-483-1185
    - Hovedetterforsker:
      
      Koosha Mortazavi
  - San Dimas, California, Forente stater, 91773
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    - North America Research Institute-San Dimas
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      Aamir Jamal
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      Telefonnummer: 800-797-1695
- Florida
  - Bradenton, Florida, Forente stater, 34209
    - Rekruttering
    - Nova Clinical Research, LLC
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      Telefonnummer: 941-792-6564
    - Hovedetterforsker:
      
      Hakan Toka
  - Gainesville, Florida, Forente stater, 32610
    - Rekruttering
    - University of Florida - Gainesville - 1600 SW Archer Rd
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      Telefonnummer: 352-294-5068
    - Hovedetterforsker:
      
      Wai Lau
  - Hollywood, Florida, Forente stater, 33024
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    - Royal Research, Corp.
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      Telefonnummer: 954-940-0208
    - Hovedetterforsker:
      
      Elio Torres
  - Orlando, Florida, Forente stater, 32806
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    - Central Florida Kidney Specialists
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      Arvind Madan
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      Telefonnummer: 407-472-5120
  - Port Saint Lucie, Florida, Forente stater, 34952
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    - CDC Research Institute, LLC
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      Telefonnummer: 772-807-1636
    - Hovedetterforsker:
      
      Pablo Puello Diaz
- Georgia
  - Acworth, Georgia, Forente stater, 30101
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- Massachusetts
  - Boston, Massachusetts, Forente stater, 02115-6110
    - Rekruttering
    - Brigham and Women's Hospital
    - Hovedetterforsker:
      
      Finnian McCausland
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      Telefonnummer: 617-732-8327
  - Boston, Massachusetts, Forente stater, 02114-4724
    - Rekruttering
    - The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital
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      Telefonnummer: 617-726-4132
    - Hovedetterforsker:
      
      Harish Seethapathy
  - Worcester, Massachusetts, Forente stater, 01655
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    - UMass Memorial Medical Center
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      Telefonnummer: 413-324-8626
    - Hovedetterforsker:
      
      Xavier Vela Parada
- Michigan
  - Detroit, Michigan, Forente stater, 48202
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    - Henry Ford Hospital
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      Douglas Atchison
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      Telefonnummer: 313-916-0026
  - Pontiac, Michigan, Forente stater, 48341
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    - Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
- Mississippi
  - Brookhaven, Mississippi, Forente stater, 39601
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    - Anointed Nephrology and HTN - SKYCRNG - PPDS
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      Telefonnummer: 601-833-4111
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      James Hall
- Missouri
  - City of Saint Peters, Missouri, Forente stater, 63376
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    - Midwest Nephrology Associates,Inc.
- New York
  - New York, New York, Forente stater, 10029-6504
    - Rekruttering
    - Icahn School of Medicine at Mount Sinai
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      Telefonnummer: 646-286-0194
    - Hovedetterforsker:
      
      Nicholas Chun
  - The Bronx, New York, Forente stater, 10468
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    - James J Peters Veterans Administration Medical Center - NAVREF - PPDS
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      Chang Xu
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      Telefonnummer: 71858490006099
- Pennsylvania
  - Philadelphia, Pennsylvania, Forente stater, 19104
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    - Penn Renal Electrolyte and Hypertension Perelman
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      Gaia Coppock
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      Telefonnummer: 347-466-2774
- Rhode Island
  - Providence, Rhode Island, Forente stater, 02903
    - Rekruttering
    - Lifespan at Rhode Island Hospital
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      Jie Tang
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      Telefonnummer: 401-444-6844
- Tennessee
  - Knoxville, Tennessee, Forente stater, 37923-3624
    - Rekruttering
    - Knoxville Kidney Center, PLLC
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      Telefonnummer: 865 692-3462
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      George Newman
- Texas
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      Telefonnummer: 214-396-4950
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      Sumit Kumar
  - Houston, Texas, Forente stater, 77054
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      Telefonnummer: 832-338-9118
    - Hovedetterforsker:
      
      Biruh Workeneh
  - Katy, Texas, Forente stater, 77974
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    - Hovedetterforsker:
      
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- Wisconsin
  - Milwaukee, Wisconsin, Forente stater, 53226
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      Anna Gaddy
Frankrike
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    - CHU Amiens Picardie - Site Sud
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      Telefonnummer: +33 322455862
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      Gabriel Choukroun
  - Paris, Frankrike, 75020
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      Khalil El Karoui
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      Evangeline Pillebout
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      Telefonnummer: +33 142499631
- Bas-Rhin
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    - CHU de Strasbourg - Nouvel Hôpital Civil
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      Telefonnummer: 33369551629
    - Hovedetterforsker:
      
      Anna Duval
- Dobus
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    - CHU de Besançon
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      Telefonnummer: 33381218204
    - Hovedetterforsker:
      
      Melchior Chabannes
- Gironde
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    - CHU de Bordeaux - Hôpital Pellegrin
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      Claire Rigothier
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      Telefonnummer: 33557820800
- Grand Est
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    - CHU de Reims - Hôpital Maison Blanche
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      Telefonnummer: +33326787878
    - Hovedetterforsker:
      
      Vincent Verdier
- Haut-Rhin
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    - GHRMSA - Hôpital Emile Muller
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      Francois Chantrel
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      Telefonnummer: 33389646738
- Hauts-de-Seine
  - Suresnes, Hauts-de-Seine, Frankrike, 92150
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    - Hopital Foch
    - Hovedetterforsker:
      
      Arwa Jalal Eddine
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      Telefonnummer: 33146253144
- Loiret
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      Telefonnummer: +33 238651456
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      Manon Dekeyser
- Occitanie
  - Nîmes Cédex 9, Occitanie, Frankrike, 30929
    - Rekruttering
    - CHU de Nîmes - Hopital Universitaire Caremeau
    - Hovedetterforsker:
      
      Olivier Moranne
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      Telefonnummer: +33779058852
- Val-de-Marne
  - Créteil, Val-de-Marne, Frankrike, 94000
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    - AP-HP - Hôpital Henri Mondor
    - Hovedetterforsker:
      
      Vincent Audard
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      Telefonnummer: +33 149814408
- Vendée
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    - Centre Hospitalier Departemental de Vendee
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      Telefonnummer: +33 251446572
    - Hovedetterforsker:
      
      Charles Ronsin
Hellas
- - Ioannina, Hellas, 34098
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    - University General Hospital of Ioannina
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      Telefonnummer: 302651007507
    - Hovedetterforsker:
      
      Evangelia Ntounousi
  - Thessaloniki, Hellas, 54636
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    - AHEPA University General Hospital of Thessaloniki
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      Telefonnummer: 306986670500
    - Hovedetterforsker:
      
      Vassilios Liakopoulos
  - Thessaloniki, Hellas, 57010
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    - General Hospital of Thessaloniki ''G. Papanikolaou''
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      Telefonnummer: 306972244472
    - Hovedetterforsker:
      
      Gerasimos Bamichas
- Achaïa
  - Pátrai, Achaïa, Hellas, 26500
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    - University General Hospital of Patras
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      Telefonnummer: 306949548822
    - Hovedetterforsker:
      
      Evangelos Papachristou
- Attica
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    - Laiko General Hospital of Athens
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      Telefonnummer: 302132061476
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      Smaragdi Marinaki
  - Athens, Attica, Hellas, 115 27
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    - General Hospital of Athens ''G. Gennimatas''
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      Telefonnummer: 6974466366
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      Georgios Moustakas
  - Athens, Attica, Hellas, 115 27
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    - General Hospital of Athens ''Hippokratio''
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      Telefonnummer: 302132088375
    - Hovedetterforsker:
      
      Dimitros Petras
  - Chaïdári, Attica, Hellas, 12462
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    - University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
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      Telefonnummer: 6970178793
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      Sophia Lionaki
- Irakleio
  - Heraklion, Irakleio, Hellas, 714 09
    - Rekruttering
    - General Hospital of Heraklion Venizeleio
    - Ta kontakt med:
      
      Telefonnummer: 306974737879
    - Hovedetterforsker:
      
      Dimitris Xydakis
  - Heraklion, Irakleio, Hellas, 715 00
    - Rekruttering
    - PAGNI-University General Hospital of Heraklion
    - Hovedetterforsker:
      
      Konstantinos Stylianou
    - Ta kontakt med:
      
      Telefonnummer: 306944025099
India
- - Chandigarh, India, 160012
    - Rekruttering
    - Postgraduate Institute of Medical Education & Research (PGIMER)
- Andhra Pradesh
  - Hyderabad, Andhra Pradesh, India, 500082
    - Rekruttering
    - Nizams Institute of Medical Sciences
  - Hyderabad, Andhra Pradesh, India, 500012
    - Rekruttering
    - Osmania General Hospital
- Chhattisgarh
  - Raipur, Chhattisgarh, India, 492099
    - Rekruttering
    - All India Institute of Medical Sciences ( AIIMS ) - Raipur
- Gujarat
  - Ahmedabad, Gujarat, India, 380081
    - Rekruttering
    - Zydus Hospital
  - Nadiād, Gujarat, India, 387001
    - Rekruttering
    - Muljibhai Patel Society for Research in Nephro-Urology
- Karnataka
  - Bangalore, Karnataka, India, 560017
    - Rekruttering
    - Manipal Hospital Bangalore
  - Bangalore, Karnataka, India, 560054
    - Tilbaketrukket
    - M.S. Ramaiah Medical College and Hospital
- Kerala
  - Kozhikode, Kerala, India, 673008
    - Rekruttering
    - Government Medical College, Kozhikode
  - Trivandrum, Kerala, India, 695011
    - Tilbaketrukket
    - Trivandrum Medical College Hospital
- Maharashtra
  - Mumbai, Maharashtra, India, 400012
    - Rekruttering
    - Seth G S Medical College and K E M Hospital
  - Pune, Maharashtra, India, 411013
    - Tilbaketrukket
    - Noble Hospital
- National Capital Territory of Delhi
  - New Delhi, National Capital Territory of Delhi, India, 110060
    - Rekruttering
    - Sir Ganga Ram Hospital
  - New Delhi, National Capital Territory of Delhi, India, 110017
    - Rekruttering
    - Max Super Speciality Hospital - Saket
- Uttar Pradesh
  - Lucknow, Uttar Pradesh, India, 226003
    - Rekruttering
    - King George Medical University
  - Lucknow, Uttar Pradesh, India, 226014
    - Rekruttering
    - Sanjay Gandhi Postgraduate Institute of Medical Sciences
- West Bengal
  - Kolkata, West Bengal, India, 700014
    - Rekruttering
    - Nil Ratan Sircar Medical College and Hospital
Italia
- Apulia
  - Bari, Apulia, Italia, 70124
    - Rekruttering
    - Azienda Ospedaliero Universitaria Consorziale Policlinico
    - Hovedetterforsker:
      
      Loreto Gesualdo
    - Ta kontakt med:
      
      Telefonnummer: 390881736002
- Emilia-Romagna
  - Fontevivo, Emilia-Romagna, Italia, 43010
    - Rekruttering
    - Azienda Ospedaliero Universitaria di Parma
    - Ta kontakt med:
      
      Telefonnummer: 390522000000
    - Hovedetterforsker:
      
      Enrico Fiaccadori
  - Modena, Emilia-Romagna, Italia, 41124
    - Rekruttering
    - Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
    - Ta kontakt med:
      
      Telefonnummer: 390594224136
    - Hovedetterforsker:
      
      Riccardo Magistroni
  - Piacenza, Emilia-Romagna, Italia, 29121
    - Rekruttering
    - AUSL Piacenza - Ospedale Guglielmo da Saliceto
    - Ta kontakt med:
      
      Telefonnummer: 390523302176
    - Hovedetterforsker:
      
      Roberto Scarpioni
- Friuli Venezia Giulia
  - Trieste, Friuli Venezia Giulia, Italia, 34149
    - Rekruttering
    - Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
    - Ta kontakt med:
      
      Telefonnummer: 393489241319
    - Hovedetterforsker:
      
      Vittorio Di Maso
- Liguria
  - Genoa, Liguria, Italia, 16132
    - Har ikke rekruttert ennå
    - IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino
    - Hovedetterforsker:
      
      Pasquale Esposito
    - Ta kontakt med:
      
      Telefonnummer: 390105557162
- Lombardy
  - Brescia, Lombardy, Italia, 25123
    - Rekruttering
    - ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
    - Hovedetterforsker:
      
      Federico Alberici
    - Ta kontakt med:
      
      Telefonnummer: 390304000000
  - Ranica, Lombardy, Italia, 24020
    - Rekruttering
    - Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò
    - Hovedetterforsker:
      
      Matias Trillini
    - Ta kontakt med:
      
      Telefonnummer: +39 0354535309
  - Rozzano, Lombardy, Italia, 20089
    - Rekruttering
    - IRCCS Istituto Clinico Humanitas
    - Ta kontakt med:
      
      Telefonnummer: 390255034583
    - Hovedetterforsker:
      
      Gabroella Moroni
- Piedmont
  - Novara, Piedmont, Italia, 28100
    - Tilbaketrukket
    - Azienda Ospedaliero Universitaria Maggiore della Carità
  - Turin, Piedmont, Italia, 10154
    - Rekruttering
    - ASL Città di Torino - Ospedale San Giovanni Bosco
    - Ta kontakt med:
      
      Telefonnummer: 393428507553
    - Hovedetterforsker:
      
      Fenoglio Fenoglio
- Tuscany
  - Florence, Tuscany, Italia, 50134
    - Rekruttering
    - ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda
    - Ta kontakt med:
      
      Telefonnummer: 390264444686
    - Hovedetterforsker:
      
      Enrico Minetti
Japan
- Aiti
  - Toyoake-shi, Aiti, Japan, 470-1192
    - Rekruttering
    - Fujita Health University Hospital
- Aomori
  - Hirosaki-shi, Aomori, Japan, 036-8563
    - Rekruttering
    - Hirosaki University Hospital
- Chiba
  - Chiba, Chiba, Japan, 260-8712
    - Rekruttering
    - National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
  - Urayasu-Shi, Chiba, Japan, 279-0021
    - Rekruttering
    - Juntendo University Urayasu Hospital
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Rekruttering
    - Hokkaido University Hospital
- Hukuoka
  - Kitakyushu-shi, Hukuoka, Japan, 807-8556
    - Rekruttering
    - Hospital of the University of Occupational and Environmental Health, Japan
- Hukusima
  - Fukushima, Hukusima, Japan, 960-1247
    - Rekruttering
    - Fukushima Medical University Hospital
- Kanagawa
  - Kawasaki-shi, Kanagawa, Japan, 213-0015
    - Rekruttering
    - Toranomon Hospital Kajigaya
  - Sagamihara-shi, Kanagawa, Japan, 252-0375
    - Rekruttering
    - Kitasato University Hospital
  - Yokohama, Kanagawa, Japan, 236-0004
    - Rekruttering
    - Yokohama City University Hospital
- Kyôto
  - Kyoto, Kyôto, Japan, 602-8566
    - Rekruttering
    - University Hospital, Kyoto Prefectural University of Medicine
- Miyagi
  - Sendai, Miyagi, Japan, 983-8512
    - Rekruttering
    - Tohoku Medical and Pharmaceutical University Hospital
- Nara
  - Kashihara, Nara, Japan, 634-8522
    - Rekruttering
    - Nara Medical University Hospital
- Okayama-ken
  - Kurashiki, Okayama-ken, Japan, 701-0192
    - Rekruttering
    - Kawasaki Medical School Hospital
- Sizouka
  - Hamamatsu, Sizouka, Japan, 431-3192
    - Rekruttering
    - Hamamatsu University Hospital
- Tokushima
  - Tokushima, Tokushima, Japan, 770-8503
    - Rekruttering
    - Tokushima University Hospital
- Tokyo
  - Ashikaga-Shi, Tokyo, Japan, 326-0843
    - Rekruttering
    - The Jikei University West Medical Center
  - Bunkyo-Ku, Tokyo, Japan, 113-8431
    - Rekruttering
    - Juntendo University Hospital
  - Minato-ku, Tokyo, Japan, 105-8471
    - Rekruttering
    - Jikei University Hospital
  - Shinagawa-ku, Tokyo, Japan, 142-86666
    - Rekruttering
    - Showa Medical University Hospital
- Ôsaka
  - Ikeda-shi, Ôsaka, Japan, 563-8510
    - Rekruttering
    - Ikeda Municipal Hospital
  - Suita-shi, Ôsaka, Japan, 565-0871
    - Rekruttering
    - Osaka University Hospital
Kina
- Anhui
  - Fuyang, Anhui, Kina, 236000
    - Rekruttering
    - Fu Yang People's Hospital - South Campus
  - Hefei, Anhui, Kina, 230022
    - Rekruttering
    - The First Affiliated Hospital of Anhui Medical University - Jixilu Campus
- Beijing Municipality
  - Beijing, Beijing Municipality, Kina, 102218
    - Rekruttering
    - Beijing Tsinghua Changgung Hospital
  - Beijing, Beijing Municipality, Kina, 100034
    - Rekruttering
    - Peking University First Hospital - Changqiao Campus
- Fujian
  - Fuzhou, Fujian, Kina, 350001
    - Rekruttering
    - Fujian Medical University Union Hospital
  - Xiamen, Fujian, Kina, 361004
    - Rekruttering
    - Zhongshan Hospital Xiamen University
- Gansu
  - Lanzhou, Gansu, Kina, 730000
    - Rekruttering
    - Gansu Provincial Hospital
- Guangdong
  - Guangzhou, Guangdong, Kina, 510120
    - Rekruttering
    - The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus
  - Guangzhou, Guangdong, Kina, 510120
    - Rekruttering
    - Sun Yat-sen Memorial Hospital, Sun Yat-sen University - North Campus
  - Shenzhen, Guangdong, Kina, 518036
    - Rekruttering
    - Peking University Shenzhen Hospital
  - Shenzhen, Guangdong, Kina, 510086
    - Rekruttering
    - Shenzhen Hospital of Southern Medical University
  - Zhongshan, Guangdong, Kina, 528401
    - Rekruttering
    - Zhongshan Hospital of Traditional Chinese Medicine
- Guangxi
  - Nanning, Guangxi, Kina, 530021
    - Rekruttering
    - The First Affiliated Hospital of Guangxi Medical University
  - Nanning, Guangxi, Kina, 530021
    - Rekruttering
    - The People's Hospital of Guangxi Zhuang Autonomous Region
- Guiyang
  - Guiyang, Guiyang, Kina, 550000
    - Rekruttering
    - Guizhou Provincial People's Hospital
- Guizhou
  - Guiyang, Guizhou, Kina, 550000
    - Rekruttering
    - The Affiliated Hospital of Guizhou Medical University
- Hebei
  - Cangzhou, Hebei, Kina, 61011
    - Rekruttering
    - Cangzhou Central Hospital
  - Shijiazhuang, Hebei, Kina, 50000
    - Rekruttering
    - The Second Hospital of Hebei Medical University - Main
  - Shijiazhuang, Hebei, Kina, 50000
    - Rekruttering
    - The Third Hospital of Hebei Medical University
- Heilongjiang
  - Daqing, Heilongjiang, Kina, 163001
    - Rekruttering
    - Daqing Oilfield General Hospital
- Henan
  - Luoyang, Henan, Kina, 471003
    - Rekruttering
    - The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
- Hong Kong
  - Hong Kong, Hong Kong, Kina, 999077
    - Rekruttering
    - Queen Mary Hospital PPDS
  - Hong Kong, Hong Kong, Kina, 999077
    - Rekruttering
    - Prince of Wales Hospital - Hong Kong
  - Hong Kong, Hong Kong, Kina, 999077
    - Rekruttering
    - Tung Wah Hospital
- Hubei
  - Wuhan, Hubei, Kina, 430223
    - Rekruttering
    - Renmin Hospital of Wuhan University - Main Campus
  - Yichang, Hubei, Kina, 443003
    - Rekruttering
    - Yichang Central People's Hospital - Wujiagang Campus
- Jiangsu
  - Nanjing, Jiangsu, Kina, 210011
    - Rekruttering
    - The Second Affiliated Hospital of Nanjing Medical University
  - Nantong, Jiangsu, Kina, 226001
    - Rekruttering
    - Affiliated Hospital of Nantong University
  - Wuxi, Jiangsu, Kina, 214023
    - Rekruttering
    - Wuxi Peoples Hospital
- Liaoning
  - Shenyang, Liaoning, Kina, 110022
    - Tilbaketrukket
    - Shengjing Hospital of China Medical University - Huaxiang Campus
- Shandong
  - Jinan, Shandong, Kina, 250012
    - Rekruttering
    - Qilu Hospital of Shandong University
  - Jinan, Shandong, Kina, 250033
    - Rekruttering
    - The Second Hospital of Shandong University
  - Yantai, Shandong, Kina, 264000
    - Har ikke rekruttert ennå
    - Yantai Yuhuangding Hospital
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, Kina, 200080
    - Rekruttering
    - Shanghai General Hospital - North Campus
  - Shanghai, Shanghai Municipality, Kina, 201899
    - Rekruttering
    - Jiading Central Hospital
  - Shanghai, Shanghai Municipality, Kina, 200023
    - Rekruttering
    - Zhongshan Hospital Fudan University
  - Shanghai, Shanghai Municipality, Kina, 200040
    - Rekruttering
    - Huashan Hospital Fudan University - PPDS
- Sichuan
  - Chengdu, Sichuan, Kina, 610072
    - Rekruttering
    - Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
- Zhejiang
  - Jinhua, Zhejiang, Kina, 321000
    - Rekruttering
    - Jinhua Municipal Central Hospital
  - Taizhou, Zhejiang, Kina, 317000
    - Rekruttering
    - Taizhou Hospital of Zhejiang Province - Main
Kroatia
- - Rijeka, Kroatia, 51000
    - Rekruttering
    - Clinical Hospital Center Rijeka
    - Ta kontakt med:
      
      Telefonnummer: 38551407487
    - Hovedetterforsker:
      
      Ivan Bubic
  - Rijeka, Kroatia, 51000
    - Rekruttering
    - Special Hospital Medico
    - Ta kontakt med:
      
      Telefonnummer: 385072100700
    - Hovedetterforsker:
      
      Bozidar Vujicic
- City of Zagreb
  - Zagreb, City of Zagreb, Kroatia, 10000
    - Rekruttering
    - Polyclinic Bonifarm
    - Ta kontakt med:
      
      Telefonnummer: 385915020024
    - Hovedetterforsker:
      
      Ivana Vukovic Brinar
  - Zagreb, City of Zagreb, Kroatia, 10000
    - Rekruttering
    - Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
    - Ta kontakt med:
      
      Telefonnummer: 385912097060
    - Hovedetterforsker:
      
      Tonko Gulin
Malaysia
- Pahang
  - Kuantan, Pahang, Malaysia, 25100
    - Rekruttering
    - Hospital Tengku Ampuan Afzan
  - Perak, Pahang, Malaysia, 30450
    - Rekruttering
    - Hospital Raja Permaisuri Bainun
- WilayahPersekutuan KualaLumpur
  - Lembah Pantai, WilayahPersekutuan KualaLumpur, Malaysia, 59100
    - Rekruttering
    - University Malaya Medical Centre
New Zealand
- - Auckland, New Zealand, 1023
    - Rekruttering
    - Auckland City Hospital
  - Auckland, New Zealand, 2025
    - Rekruttering
    - Aotearoa Clinical Trials Trust- Middlemore Hospital
  - Wellington, New Zealand, 6021
    - Rekruttering
    - Wellington Hospital
Polen
- - Szczecin, Polen, 70-110
    - Rekruttering
    - Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
    - Ta kontakt med:
      
      Telefonnummer: 48506688624
    - Hovedetterforsker:
      
      Kazimierz Ciechanowski
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Polen, 31-559
    - Rekruttering
    - SCM Clinic - Prywatny Szpital Specjalistyczny
    - Hovedetterforsker:
      
      Dariusz Aksamit
    - Ta kontakt med:
      
      Telefonnummer: +48664802950
  - Krakow, Lesser Poland Voivodeship, Polen, 30727
    - Rekruttering
    - MCM Krakow - PRATIA - PPDS
    - Ta kontakt med:
      
      Telefonnummer: 48122954139
    - Hovedetterforsker:
      
      Przemyslaw Miarka
- Lódzkie
  - Lodz, Lódzkie, Polen, 92-213
    - Rekruttering
    - SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
    - Hovedetterforsker:
      
      Michal Nowicki
    - Ta kontakt med:
      
      Telefonnummer: 48422014400
- Pomeranian Voivodeship
  - Gdansk, Pomeranian Voivodeship, Polen, 80-952
    - Rekruttering
    - Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7
    - Ta kontakt med:
      
      Telefonnummer: 48791830095
    - Hovedetterforsker:
      
      Slawomir Lizakowski
- West Pomeranian Voivodeship
  - Szczecin, West Pomeranian Voivodeship, Polen, 71-434
    - Rekruttering
    - Twoja Przychodnia - Szczecinskie Centrum Medyczne
    - Ta kontakt med:
      
      Telefonnummer: 48609900745
    - Hovedetterforsker:
      
      Katarzyna Bobrek-Lesiakowska
Portugal
- - Aveiro, Portugal, 3814
    - Rekruttering
    - ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
    - Ta kontakt med:
      
      Telefonnummer: +35 1930421587
    - Hovedetterforsker:
      
      Joana Vidinha
  - Braga, Portugal, 4710-243
    - Rekruttering
    - Centro Clínico Académico, Braga - Hospital de Braga
    - Ta kontakt med:
      
      Telefonnummer: +35 125-302-7000
    - Hovedetterforsker:
      
      Raquel Vaz
  - Coimbra, Portugal, 3004-561
    - Rekruttering
    - ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
    - Ta kontakt med:
      
      Telefonnummer: 351239400400
    - Hovedetterforsker:
      
      Emanuel Ferreira
  - Leiria, Portugal, 2410-197
    - Rekruttering
    - ULS da Região de Leiria, EPE - Hospital de Santo André
    - Ta kontakt med:
      
      Telefonnummer: 351244817000
    - Hovedetterforsker:
      
      Joana Silva
  - Setúbal, Portugal, 2910-446
    - Rekruttering
    - ULS da Arrábida, EPE - Hospital de São Bernardo
    - Ta kontakt med:
      
      Telefonnummer: +35 126 554-9048
    - Hovedetterforsker:
      
      Ana Farinha
- Lisbon District
  - Carnaxide, Lisbon District, Portugal, 2790
    - Rekruttering
    - ULS de Lisboa Ocidental, EPE - Hospital Santa Cruz
    - Ta kontakt med:
      
      Telefonnummer: +35 1210433097
    - Hovedetterforsker:
      
      Eunice Cacheira
  - Vila Nova de Gaia, Lisbon District, Portugal, 4434-502
    - Rekruttering
    - ULS de Gaia/Espinho, EPE - Unidade I
    - Ta kontakt med:
      
      Telefonnummer: 351227865100
    - Hovedetterforsker:
      
      Ana Gomes
Puerto Rico
- - San Juan, Puerto Rico, 00927
    - Rekruttering
    - FDI Clinical Research
    - Ta kontakt med:
      
      Telefonnummer: (787) 763-7423
    - Hovedetterforsker:
      
      Jose Cangiano-Rivera
Spania
- - Barcelona, Spania, 8035
    - Rekruttering
    - Hospital Universitario Vall d'Hebron - PPDS
    - Hovedetterforsker:
      
      Maria Jose Soler Romeo
    - Ta kontakt med:
      
      Telefonnummer: 4661 34932746000
  - Cáceres, Spania, 10003
    - Rekruttering
    - Hospital General San Pedro de Alcantara
    - Ta kontakt med:
      
      Telefonnummer: 34605248551
    - Hovedetterforsker:
      
      Pedro Jesus Labrador Gomez
  - Girona, Spania, 17007
    - Rekruttering
    - Hospital Universitari de Girona Dr Josep Trueta
    - Ta kontakt med:
      
      Telefonnummer: 324 872987087
    - Hovedetterforsker:
      
      Nadia Martin Alemany
  - Madrid, Spania, 28041
    - Rekruttering
    - Hospital Universitario 12 de Octubre
    - Hovedetterforsker:
      
      Eduardo Gutierrez Martinez
    - Ta kontakt med:
      
      Telefonnummer: +34 913908208
  - Madrid, Spania, 28040
    - Rekruttering
    - Hospital Universitario Fundacion Jimenez Diaz
    - Ta kontakt med:
      
      Telefonnummer: 3325 34915504800
    - Hovedetterforsker:
      
      Alberto Ortiz Arduan
  - Seville, Spania, 41009
    - Rekruttering
    - Hospital Universitario Virgen Macarena
    - Ta kontakt med:
      
      Telefonnummer: 34676546066
    - Hovedetterforsker:
      
      Mercedes Lazo Salgueira
  - Zaragoza, Spania, 50009
    - Rekruttering
    - Hospital Universitario Miguel Servet
    - Ta kontakt med:
      
      Telefonnummer: 34976765624
    - Hovedetterforsker:
      
      Olga Gracia Garcia
- Barcelona
  - Viladecans, Barcelona, Spania, 8840
    - Rekruttering
    - Fundacio Puigvert
    - Ta kontakt med:
      
      Telefonnummer: 34934169700
    - Hovedetterforsker:
      
      Helena Marco Rusiñol
- Catalonia
  - Barcelona, Catalonia, Spania, 8003
    - Rekruttering
    - Hospital del Mar
    - Ta kontakt med:
      
      Telefonnummer: 34932483689
    - Hovedetterforsker:
      
      Eva Rodriguez Garcia
- Galicia
  - A Coruña, Galicia, Spania, 15006
    - Rekruttering
    - Hospital Universitario A Coruña
    - Ta kontakt med:
      
      Telefonnummer: +34636889908
    - Hovedetterforsker:
      
      Catuxa Rodriguez Magarinos
- Madrid
  - Alcorcón, Madrid, Spania, 28922
    - Rekruttering
    - Hospital Universitario Fundacion Alcorcon
    - Ta kontakt med:
      
      Telefonnummer: +34 916219400
    - Hovedetterforsker:
      
      Eva Lopez Melero
  - Getafe, Madrid, Spania, 10400
    - Rekruttering
    - Hospital Universitario de Getafe
    - Ta kontakt med:
      
      Telefonnummer: 6622026800
    - Hovedetterforsker:
      
      Judith Fatima Martins Muñoz
Storbritannia
- Greater London
  - London, Greater London, Storbritannia, EC2Y 8EA
    - Rekruttering
    - St Pancras Clinical Research
    - Ta kontakt med:
      
      Telefonnummer: 442038651142
    - Hovedetterforsker:
      
      Muhammad Magdi Yaqoob
- Lancashire
  - Preston, Lancashire, Storbritannia, PR2 9HT
    - Rekruttering
    - Royal Preston Hospital - NWCRN- PPDS
    - Ta kontakt med:
      
      Telefonnummer: 441772522031
    - Hovedetterforsker:
      
      Arvind Ponnusamy
- Leicestershire
  - Leicester, Leicestershire, Storbritannia, LE5 4PW
    - Rekruttering
    - Leicester General Hospital
    - Ta kontakt med:
      
      Telefonnummer: 4401162584870
    - Hovedetterforsker:
      
      Chee Kay Cheung
- South Yorkshire
  - Sheffield, South Yorkshire, Storbritannia, S5 7AU
    - Rekruttering
    - Northern General Hospital
    - Ta kontakt med:
      
      Telefonnummer: 441142715199
    - Hovedetterforsker:
      
      Salim Arif Khwaja
- Staffordshire
  - Stoke-on-Trent, Staffordshire, Storbritannia, ST4 6QG
    - Rekruttering
    - Royal Stoke University Hospital
    - Ta kontakt med:
      
      Telefonnummer: 441782672724
    - Hovedetterforsker:
      
      Diane (Julie) Wessels
Sør -Korea
- - Busan, Sør -Korea, 48108
    - Rekruttering
    - Inje University Haeundae Paik Hospital
  - Seoul, Sør -Korea, 03080
    - Rekruttering
    - Seoul National University Hospital
  - Seoul, Sør -Korea, 6351
    - Rekruttering
    - Samsung Medical Center
- Gwangyeogsi
  - Busan, Gwangyeogsi, Sør -Korea, 49241
    - Rekruttering
    - Pusan National University Hospital
- Gyeonggido
  - Anyang-si, Gyeonggido, Sør -Korea, 14068
    - Rekruttering
    - Hallym University Sacred Heart Hospital
  - Seongnam-si, Gyeonggido, Sør -Korea, 13620
    - Rekruttering
    - Seoul National University Bundang Hospital
  - Suwon, Gyeonggido, Sør -Korea, 16499
    - Rekruttering
    - Ajou University Hospital
- Seoul Teugbyeolsi
  - Seoul, Seoul Teugbyeolsi, Sør -Korea, 3722
    - Rekruttering
    - Severance Hospital Yonsei University Health System
  - Seoul, Seoul Teugbyeolsi, Sør -Korea, 4763
    - Rekruttering
    - Hanyang University Seoul Hospital
Taiwan
- - Kaohsiung City, Taiwan, 807
    - Rekruttering
    - Kaohsiung Medical University - Chung-Ho Memorial Hospital
  - New Taipei City, Taiwan, 235041
    - Rekruttering
    - Taipei Medical University Shuang Ho Hospital
- Taiwan, Province of China
  - Dawan, Taiwan, Province of China, Taiwan, 70403
    - Rekruttering
    - National Cheng Kung University Hospital
  - New Taipei City, Taiwan, Province of China, Taiwan, 220216
    - Rekruttering
    - Far Eastern Memorial Hospital
  - Taichung, Taiwan, Province of China, Taiwan, 40447
    - Rekruttering
    - China Medical University Hospital - PPDS
  - Taipei, Taiwan, Province of China, Taiwan, 104449
    - Rekruttering
    - Mackay Memorial Hospital-Taipei branch
  - Taipei, Taiwan, Province of China, Taiwan, 116081
    - Rekruttering
    - Taipei Municipal Wanfang Hospital
  - Taoyuan, Taiwan, Province of China, Taiwan, 33305
    - Rekruttering
    - Chang Gung Memorial Hospital, Linkou
Tsjekkia
- Prague
  - Prague, Prague, Tsjekkia, 128 08
    - Rekruttering
    - Vseobecna Fakultni Nemocnice V Praze
    - Hovedetterforsker:
      
      Vladimir Tesar
    - Ta kontakt med:
      
      Telefonnummer: 420224966790
- Praha, Hlavní Mesto
  - Prague, Praha, Hlavní Mesto, Tsjekkia, 140 21
    - Rekruttering
    - Institut klinicke a experimentalni mediciny
    - Ta kontakt med:
      
      Telefonnummer: 420236052254
    - Hovedetterforsker:
      
      Ondrej Viklicky
Tyrkia (Türkiye)
- - Antalya, Tyrkia (Türkiye), 7070
    - Rekruttering
    - Akdeniz University Medical Faculty
    - Ta kontakt med:
      
      Telefonnummer: 905309672612
    - Hovedetterforsker:
      
      Funda Sari Bahceci
  - Istanbul, Tyrkia (Türkiye), 34098
    - Rekruttering
    - Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi Hastanesi
    - Hovedetterforsker:
      
      Nurhan Seyahi
    - Ta kontakt med:
      
      Telefonnummer: 905379535596
  - Kayseri, Tyrkia (Türkiye), 38039
    - Rekruttering
    - Erciyes Universitesi Tip Fakultesi Gevher Nesibe Hastanesi
    - Hovedetterforsker:
      
      Ismail Kocyigit
    - Ta kontakt med:
      
      Telefonnummer: +905305811661
  - Konya, Tyrkia (Türkiye), 42090
    - Rekruttering
    - Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi
    - Hovedetterforsker:
      
      Kultigin Turkmen
    - Ta kontakt med:
      
      Telefonnummer: 9005384927877
- Kocaeli
  - İzmit, Kocaeli, Tyrkia (Türkiye), 41380
    - Rekruttering
    - Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
    - Hovedetterforsker:
      
      Necmi Eren
    - Ta kontakt med:
      
      Telefonnummer: +905366301577
- Turkey
  - Ankara, Turkey, Tyrkia (Türkiye), 34899
    - Rekruttering
    - Ankara Bilkent Sehir Hastanesi
    - Ta kontakt med:
      
      Telefonnummer: 905353665205
    - Hovedetterforsker:
      
      Faith Dede
  - Istanbul, Turkey, Tyrkia (Türkiye), 34899
    - Rekruttering
    - Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
    - Ta kontakt med:
      
      Telefonnummer: 905303230775
    - Hovedetterforsker:
      
      Izzet Arikan
  - Sanliurfa, Turkey, Tyrkia (Türkiye), 63040
    - Rekruttering
    - Mehmet Akif Inan Egitim ve Arastirma Hastanesi
    - Ta kontakt med:
      
      Telefonnummer: 905539811595
    - Hovedetterforsker:
      
      Tuncay Sahutoglu
Tyskland
- - Berlin, Tyskland, 10117
    - Rekruttering
    - Charité - Universitätsmedizin Berlin
    - Ta kontakt med:
      
      Telefonnummer: 4930450614001
    - Hovedetterforsker:
      
      Eva Schrezenmeier
  - Hamburg, Tyskland, 20246
    - Rekruttering
    - Universitätsklinikum Hamburg Eppendorf
    - Ta kontakt med:
      
      Telefonnummer: +49 152 22802076
    - Hovedetterforsker:
      
      Jule Pinter
- Baden-Wurttemberg
  - Heidelberg, Baden-Wurttemberg, Tyskland, 69120
    - Rekruttering
    - Universitätsklinikum Heidelberg
    - Hovedetterforsker:
      
      Claudia Sommerer
    - Ta kontakt med:
      
      Telefonnummer: 4962215635296
  - Stuttgart, Baden-Wurttemberg, Tyskland, 70376
    - Rekruttering
    - Robert Bosch Krankenhaus
    - Ta kontakt med:
      
      Telefonnummer: +49 711 8101-3496
    - Hovedetterforsker:
      
      Jörg Latus
  - Villingen-Schwenningen, Baden-Wurttemberg, Tyskland, 78052
    - Rekruttering
    - Nephrologisches Zentrum Villingen-Schwenningen
    - Hovedetterforsker:
      
      Bernd Hohenstein
    - Ta kontakt med:
      
      Telefonnummer: 4977219985324
- Hesse
  - Frankfurt am Main, Hesse, Tyskland, 60596
    - Rekruttering
    - Universitätsklinikum Frankfurt, Apotheke Haus 19
    - Ta kontakt med:
      
      Telefonnummer: 4969630186463
    - Hovedetterforsker:
      
      Jeannine Lang
- Lower Saxony
  - Braunschweig, Lower Saxony, Tyskland, 38126
    - Rekruttering
    - Städtisches Klinikum Braunschweig - Salzdahlumer Straße 90
    - Ta kontakt med:
      
      Telefonnummer: +49 531 595 2381
    - Hovedetterforsker:
      
      Jan Kielstein
- Rhineland-Palatinate
  - Mainz, Rhineland-Palatinate, Tyskland, 55131
    - Rekruttering
    - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    - Hovedetterforsker:
      
      Julia Weinmann-Menke
    - Ta kontakt med:
      
      Telefonnummer: 496131172503
- Saxony
  - Dresden, Saxony, Tyskland, 1307
    - Rekruttering
    - Universitätsklinikum Carl Gustav Carus an der TU Dresden
    - Hovedetterforsker:
      
      Christian Hugo
    - Ta kontakt med:
      
      Telefonnummer: 4935145818825
  - Leipzig, Saxony, Tyskland, 4103
    - Rekruttering
    - Universitätsklinikum Leipzig
    - Ta kontakt med:
      
      Telefonnummer: 4903419713350
    - Hovedetterforsker:
      
      Jan Kowald

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Key Inclusion Criteria:

Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, an IgAN diagnostic biopsy within the past 24 months prior to signing the ICF.
An eGFR ≥ 30 mL/min/1.73 m^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and < 30 mL/min/1.73 m^2 is acceptable for the cohorts 3 and 4.
Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection.
Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is); endothelin receptor antagonists (ERAs) or dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN; and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using a DEARA (e.g., sparsentan) will not be permitted to use simultaneous ACEI or ARB medication.

Key Exclusion Criteria:

Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.
History of rapidly progressive variant of IgAN, defined as eGFR loss by > 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors.
IgAN-(MCD) variant.
Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) > 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy).
Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants.
Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic glucocorticoid exposure (> 7.5 milligrams per day [mg/d] prednisone-equivalent for indications other than IgAN or any dose if given for the treatment of IgAN) within 4 months prior to Screening. Use of hydroxychloroquine in Mainland China is allowed if the candidate has been on this for at least 6 months prior to Screening with a stable dose for at least 12 weeks prior to Screening. If a potential participant requires systemic glucocorticoids at any dose for IgAN during Screening, this will result in a screen fail. If a potential participant requires systemic glucocorticoids > 7.5 mg/day prednisone-equivalent for indications other than IgAN during Screening, this will result in a screen fail.
Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible.
Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or non-prophylactic treatment with IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded.
Hypogammaglobulinemia: serum Immunoglobin G (IgG) < 6.0 gram per litre (g/L), at Screening.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Firemannsrom

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm	Intervensjon / Behandling
Eksperimentell: Cohort 1 Participants will receive several intravenous (IV) doses of felzartamab.	Legemiddel: Felzartamab Administered IV Andre navn: MOR202, MOR03087, TJ202, HIB202, BIIB148
Placebo komparator: Cohort 2 Participants will receive several IV doses of placebo.	Legemiddel: Placebo Administered IV
Eksperimentell: Cohort 3 Participants with an estimated glomerular filtration rate (eGFR) ≥ 20 and <30 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) will receive several IV doses of felzartamab.	Legemiddel: Felzartamab Administered IV Andre navn: MOR202, MOR03087, TJ202, HIB202, BIIB148
Placebo komparator: Cohort 4 Participants with an eGFR ≥ 20 and <30 mL/min/1.73m^2 will receive several IV doses of placebo.	Legemiddel: Placebo Administered IV

Hva måler studien?

Primære resultatmål

Resultatmål	Tidsramme
Prosentvis endring fra baseline i proteinuria målt ved urinproteinet: kreatininforhold (UPCR) Tidsramme: Baseline opp til uke 36	Baseline opp til uke 36

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Endring fra baseline i estimert glomerulær filtreringshastighet (EGFR) verdier beregnet ved bruk av den kroniske nyresykdommens epidemiologi (CKD-EPI) kreatininligning Tidsramme: Baseline opp til uke 104		Baseline opp til uke 104
Prosentandel av deltakerne som krever redningsterapi Tidsramme: Baseline opp til uke 104		Baseline opp til uke 104
Endring fra baseline i EGFR-verdier beregnet ved bruk av CKD-EPI-kreatinin-ligningen Tidsramme: Baseline opp til uke 52		Baseline opp til uke 52
Felzartamab serumkonsentrasjoner over tid Tidsramme: Predose og ved flere tidspunkter postdose opp til uke 36		Predose og ved flere tidspunkter postdose opp til uke 36
Antall deltakere med anti-medikamentantistoffer (ADAs) mot Felzartamab Tidsramme: Baseline opp til uke 104		Baseline opp til uke 104
Prosentandel av deltakerne med behandling av fremvoksende bivirkninger (TEAE) og behandling Emergent alvorlig bivirkning (Tesae) Tidsramme: Baseline opp til uke 104		Baseline opp til uke 104
Antall deltakere med klinisk signifikant endring fra baseline i vitale tegn abnormiteter Tidsramme: Baseline opp til uke 104		Baseline opp til uke 104
Antall deltakere med klinisk signifikant endring fra baseline i laboratorieavvik Tidsramme: Baseline opp til uke 104		Baseline opp til uke 104
Antall deltakere med klinisk signifikant endring fra baseline i elektrokardiogram (EKG) abnormaliteter Tidsramme: Baseline opp til uke 104		Baseline opp til uke 104
Antall deltakere med klinisk signifikant endring fra baseline i fysiske undersøkelser abnormiteter Tidsramme: Baseline opp til uke 104		Baseline opp til uke 104
Percentage of Participants Achieving Complete Response (CR) Tidsramme: Baseline up to Week 104	CR is defined as a UPCR value (based on 24-hour urine collection) of < 0.5 gram per gram (g/g), a reduction in UPCR of ≥ 50%, and a stable eGFR (decrease from baseline in eGFR of ≤ 25%).	Baseline up to Week 104
Percentage of Participants who Progressed to Kidney Malfunction Tidsramme: Baseline up to Week 104	The percentage of participants progressing to kidney malfunction will be reported based on one of the following, 1. ≥ 40% Reduction in eGFR Sustained for ≥ 30 Days, 2. eGFR <15 mL/min/1.73 m^2 for ≥ 30 Days, 3. Undergoing Dialysis for ≥ 30 Days, 4. Undergoing Kidney Transplantation, 5. Died From Kidney Failure	Baseline up to Week 104

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Biogen

Etterforskere

Studieleder: Medical Director, Biogen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. mai 2025

Primær fullføring (Antatt)

31. mai 2027

Studiet fullført (Antatt)

5. juni 2029

Datoer for studieregistrering

Først innsendt

17. april 2025

Først innsendt som oppfylte QC-kriteriene

17. april 2025

Først lagt ut (Faktiske)

20. april 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Felzartamab

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

299IG301
2024-519345-30-00 (Annen identifikator: EU CT Number)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-planbeskrivelse

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

En studie for å lære om effekten av Felzartamab -infusjoner på voksne med immunoglobulin A nefropati (Igan) (PREVAIL)

En fase 3, randomisert, dobbeltblind, placebokontrollert studie av Felzartamab hos voksne med IgA-nefropati (Prevail)

Studieoversikt

Status

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Studietype

Registrering (Antatt)

Fase

Kontakter og plasseringer

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Beskrivelse

Studieplan

Hvordan er studiet utformet?

Designdetaljer

Antall våpen

Våpen og intervensjoner

Deltakergruppe / Arm

Intervensjon / Behandling

Hva måler studien?

Primære resultatmål

Resultatmål

Tidsramme

Sekundære resultatmål

Resultatmål

Tiltaksbeskrivelse

Tidsramme

Samarbeidspartnere og etterforskere

Sponsor

Etterforskere

Studierekorddatoer

Studer hoveddatoer

Studiestart (Faktiske)

Primær fullføring (Antatt)

Studiet fullført (Antatt)

Datoer for studieregistrering

Først innsendt

Først innsendt som oppfylte QC-kriteriene

Først lagt ut (Faktiske)

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

Siste oppdatering sendt inn som oppfylte QC-kriteriene

Sist bekreftet

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

IPD-planbeskrivelse

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Studerer et amerikansk FDA-regulert enhetsprodukt