AzTrials
AzTrials

Immunoglobulin A Nephropathy (IgAN)Phase 3PREVAILNCT06935357

A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN)

A Phase 3 study testing Felzartamab in people with Immunoglobulin A Nephropathy (IgAN), run by Biogen at 265 sites in 28 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Immunoglobulin A Nephropathy (IgAN)
What is being tested?
Felzartamab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
454 participants
Where
265 sitesin 28 countries
Study dates
8 May 2025to 5 Jun 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

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

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

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

265 sites in 28 countries. Contact the study team or a site near you to ask about taking part.

US Biogen Clinical Trial Center contact

866-633-4636

clinicaltrials@biogen.com

Global Biogen Clinical Trial Center contact

clinicaltrials@biogen.com

265 sites in 28 countries

China40 sites, 39 recruiting

  • Peking University First Hospital - Changqiao Campus

    Beijing, Beijing Municipality, 100034

    Recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102218

    Recruiting

  • Cangzhou Central Hospital

    Cangzhou, Hebei, 61011

    Recruiting

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Recruiting

  • Daqing Oilfield General Hospital

    Daqing, Heilongjiang, 163001

    Recruiting

  • Fu Yang People's Hospital - South Campus

    Fuyang, Anhui, 236000

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University - North Campus

    Guangzhou, Guangdong, 510120

    Recruiting

  • The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus

    Guangzhou, Guangdong, 510120

    Recruiting

  • Guizhou Provincial People's Hospital

    Guiyang, Guiyang, 550000

    Recruiting

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University - Jixilu Campus

    Hefei, Anhui, 230022

    Recruiting

  • Prince of Wales Hospital - Hong Kong

    Hong Kong, Hong Kong, 999077

    Recruiting

  • Queen Mary Hospital PPDS

    Hong Kong, Hong Kong, 999077

    Recruiting

  • Tung Wah Hospital

    Hong Kong, Hong Kong, 999077

    Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

    Recruiting

  • The Second Hospital of Shandong University

    Jinan, Shandong, 250033

    Recruiting

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000

    Recruiting

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

    Recruiting

  • The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus

    Luoyang, Henan, 471003

    Recruiting

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

    Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

    Recruiting

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

    Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 226001

    Recruiting

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200023

    Recruiting

  • Huashan Hospital Fudan University - PPDS

    Shanghai, Shanghai Municipality, 200040

    Recruiting

  • Shanghai General Hospital - North Campus

    Shanghai, Shanghai Municipality, 200080

    Recruiting

  • Jiading Central Hospital

    Shanghai, Shanghai Municipality, 201899

    Recruiting

  • Shengjing Hospital of China Medical University - Huaxiang Campus

    Shenyang, Liaoning, 110022

    Withdrawn

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong, 510086

    Recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

    Recruiting

  • The Second Hospital of Hebei Medical University - Main

    Shijiazhuang, Hebei, 50000

    Recruiting

  • The Third Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50000

    Recruiting

  • Taizhou Hospital of Zhejiang Province - Main

    Taizhou, Zhejiang, 317000

    Recruiting

  • Renmin Hospital of Wuhan University - Main Campus

    Wuhan, Hubei, 430223

    Recruiting

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu, 214023

    Recruiting

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

    Not yet recruiting

  • Yichang Central People's Hospital - Wujiagang Campus

    Yichang, Hubei, 443003

    Recruiting

  • Zhongshan Hospital of Traditional Chinese Medicine

    Zhongshan, Guangdong, 528401

    Recruiting

Other trials in China

United States29 sites, 25 recruiting

  • American Clinical Trials LLC

    Acworth, Georgia, 30101

    Withdrawn

  • Kidney & Hypertension Center - Apple Valley

    Apple Valley, California, 92307

    760-780-4179

    Edgard Vera Tapia

    Recruiting

  • The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital

    Boston, Massachusetts, 02114-4724

    617-726-4132

    Harish Seethapathy

    Recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115-6110

    617-732-8327

    Finnian McCausland

    Recruiting

  • Nova Clinical Research, LLC

    Bradenton, Florida, 34209

    941-792-6564

    Hakan Toka

    Recruiting

  • Anointed Nephrology and HTN - SKYCRNG - PPDS

    Brookhaven, Mississippi, 39601

    601-833-4111

    James Hall

    Recruiting

  • Scripps Green Hospital

    Carlsbad, California, 92009

    617-956-2587

    Kimberly Harper

    Recruiting

  • Midwest Nephrology Associates,Inc.

    City of Saint Peters, Missouri, 63376

    Withdrawn

  • Texas Kidney Institute - Dallas

    Dallas, Texas, 95231

    214-396-4950

    Sumit Kumar

    Recruiting

  • Henry Ford Hospital

    Detroit, Michigan, 48202

    313-916-0026

    Douglas Atchison

    Recruiting

  • University of Florida - Gainesville - 1600 SW Archer Rd

    Gainesville, Florida, 32610

    352-294-5068

    Wai Lau

    Recruiting

  • National Institute of clinical Research Administration Office

    Garden Grove, California, 92844-2751

    Withdrawn

  • Royal Research, Corp.

    Hollywood, Florida, 33024

    954-940-0208

    Elio Torres

    Recruiting

  • Provecta Research Network

    Houston, Texas, 77054

    832-338-9118

    Biruh Workeneh

    Recruiting

  • R & H Clinical Research

    Katy, Texas, 77974

    713-367-2791

    Syed Hussain

    Recruiting

  • Knoxville Kidney Center, PLLC

    Knoxville, Tennessee, 37923-3624

    692-3462 ext. 865

    George Newman

    Recruiting

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72205

    501-804-5939

    John Heifner

    Recruiting

  • UCLA Health David Geffen School of Medicine

    Los Angeles, California, 90095

    310-206-8478

    Anjay Rastogi

    Recruiting

  • Medical College of Wisconsin, Inc.

    Milwaukee, Wisconsin, 53226

    414-805-3100

    Anna Gaddy

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029-6504

    646-286-0194

    Nicholas Chun

    Recruiting

  • Central Florida Kidney Specialists

    Orlando, Florida, 32806

    407-472-5120

    Arvind Madan

    Recruiting

  • FOMAT Medical Research - FOMAT - PPDS

    Oxnard, California, 93030

    805-483-1185

    Koosha Mortazavi

    Recruiting

  • Penn Renal Electrolyte and Hypertension Perelman

    Philadelphia, Pennsylvania, 19104

    347-466-2774

    Gaia Coppock

    Not yet recruiting

  • Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS

    Pontiac, Michigan, 48341

    Withdrawn

  • CDC Research Institute, LLC

    Port Saint Lucie, Florida, 34952

    772-807-1636

    Pablo Puello Diaz

    Recruiting

  • Lifespan at Rhode Island Hospital

    Providence, Rhode Island, 02903

    401-444-6844

    Jie Tang

    Recruiting

  • North America Research Institute-San Dimas

    San Dimas, California, 91773

    800-797-1695

    Aamir Jamal

    Recruiting

  • James J Peters Veterans Administration Medical Center - NAVREF - PPDS

    The Bronx, New York, 10468

    71858490006099

    Chang Xu

    Recruiting

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

    413-324-8626

    Xavier Vela Parada

    Recruiting

Other trials in United States

Japan22 sites, 22 recruiting

  • The Jikei University West Medical Center

    Ashikaga-Shi, Tokyo, 326-0843

    Recruiting

  • Juntendo University Hospital

    Bunkyo-Ku, Tokyo, 113-8431

    Recruiting

  • National Hospital Organization Chiba Medical Center Chibahigashi National Hospital

    Chiba, Chiba, 260-8712

    Recruiting

  • Fukushima Medical University Hospital

    Fukushima, Hukusima, 960-1247

    Recruiting

  • Hamamatsu University Hospital

    Hamamatsu, Sizouka, 431-3192

    Recruiting

  • Hirosaki University Hospital

    Hirosaki-shi, Aomori, 036-8563

    Recruiting

  • Ikeda Municipal Hospital

    Ikeda-shi, Ôsaka, 563-8510

    Recruiting

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8522

    Recruiting

  • Toranomon Hospital Kajigaya

    Kawasaki-shi, Kanagawa, 213-0015

    Recruiting

  • Hospital of the University of Occupational and Environmental Health, Japan

    Kitakyushu-shi, Hukuoka, 807-8556

    Recruiting

  • Kawasaki Medical School Hospital

    Kurashiki, Okayama-ken, 701-0192

    Recruiting

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, Kyôto, 602-8566

    Recruiting

  • Jikei University Hospital

    Minato-ku, Tokyo, 105-8471

    Recruiting

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa, 252-0375

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Recruiting

  • Tohoku Medical and Pharmaceutical University Hospital

    Sendai, Miyagi, 983-8512

    Recruiting

  • Showa Medical University Hospital

    Shinagawa-ku, Tokyo, 142-86666

    Recruiting

  • Osaka University Hospital

    Suita-shi, Ôsaka, 565-0871

    Recruiting

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

    Recruiting

  • Fujita Health University Hospital

    Toyoake-shi, Aiti, 470-1192

    Recruiting

  • Juntendo University Urayasu Hospital

    Urayasu-Shi, Chiba, 279-0021

    Recruiting

  • Yokohama City University Hospital

    Yokohama, Kanagawa, 236-0004

    Recruiting

Other trials in Japan

India17 sites, 14 recruiting

  • Zydus Hospital

    Ahmedabad, Gujarat, 380081

    Recruiting

  • Manipal Hospital Bangalore

    Bangalore, Karnataka, 560017

    Recruiting

  • M.S. Ramaiah Medical College and Hospital

    Bangalore, Karnataka, 560054

    Withdrawn

  • Postgraduate Institute of Medical Education & Research (PGIMER)

    Chandigarh, 160012

    Recruiting

  • Osmania General Hospital

    Hyderabad, Andhra Pradesh, 500012

    Recruiting

  • Nizams Institute of Medical Sciences

    Hyderabad, Andhra Pradesh, 500082

    Recruiting

  • Nil Ratan Sircar Medical College and Hospital

    Kolkata, West Bengal, 700014

    Recruiting

  • Government Medical College, Kozhikode

    Kozhikode, Kerala, 673008

    Recruiting

  • King George Medical University

    Lucknow, Uttar Pradesh, 226003

    Recruiting

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    Lucknow, Uttar Pradesh, 226014

    Recruiting

  • Seth G S Medical College and K E M Hospital

    Mumbai, Maharashtra, 400012

    Recruiting

  • Muljibhai Patel Society for Research in Nephro-Urology

    Nadiād, Gujarat, 387001

    Recruiting

  • Max Super Speciality Hospital - Saket

    New Delhi, National Capital Territory of Delhi, 110017

    Recruiting

  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

    Recruiting

  • Noble Hospital

    Pune, Maharashtra, 411013

    Withdrawn

  • All India Institute of Medical Sciences ( AIIMS ) - Raipur

    Raipur, Chhattisgarh, 492099

    Recruiting

  • Trivandrum Medical College Hospital

    Trivandrum, Kerala, 695011

    Withdrawn

Other trials in India

France13 sites, 13 recruiting

  • CHU de Besançon

    Besançon, Dobus, 25000

    33381218204

    Melchior Chabannes

    Recruiting

  • CHU de Bordeaux - Hôpital Pellegrin

    Bordeaux, Gironde, 33076

    33557820800

    Claire Rigothier

    Recruiting

  • AP-HP - Hôpital Henri Mondor

    Créteil, Val-de-Marne, 94000

    +33 149814408

    Vincent Audard

    Recruiting

  • CHU Amiens Picardie - Site Sud

    Dreuil-lès-Amiens, 80470

    +33 322455862

    Gabriel Choukroun

    Recruiting

  • Centre Hospitalier Departemental de Vendee

    La Roche-sur-Yon, Vendée, 85925

    +33 251446572

    Charles Ronsin

    Recruiting

  • GHRMSA - Hôpital Emile Muller

    Mulhouse, Haut-Rhin, 68100

    33389646738

    Francois Chantrel

    Recruiting

  • CHU de Nîmes - Hopital Universitaire Caremeau

    Nîmes Cédex 9, Occitanie, 30929

    +33779058852

    Olivier Moranne

    Recruiting

  • CHRU d'Orleans- Hôpital de La Source

    Orléans, Loiret, 45067

    +33 238651456

    Manon Dekeyser

    Recruiting

  • AP-HP - Hôpital Saint-Louis

    Paris, 75010

    +33 142499631

    Evangeline Pillebout

    Recruiting

  • AP-HP - Hopital Tenon

    Paris, 75020

    +33 149814415

    Khalil El Karoui

    Recruiting

  • CHU de Reims - Hôpital Maison Blanche

    Reims, Grand Est, 51092

    +33326787878

    Vincent Verdier

    Recruiting

  • CHU de Strasbourg - Nouvel Hôpital Civil

    Strasbourg, Bas-Rhin, 67091

    33369551629

    Anna Duval

    Recruiting

  • Hopital Foch

    Suresnes, Hauts-de-Seine, 92150

    33146253144

    Arwa Jalal Eddine

    Recruiting

Other trials in France

Italy12 sites, 11 recruiting

  • Azienda Ospedaliero Universitaria Consorziale Policlinico

    Bari, Apulia, 70124

    390881736002

    Loreto Gesualdo

    Recruiting

  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

    Brescia, Lombardy, 25123

    390304000000

    Federico Alberici

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda

    Florence, Tuscany, 50134

    390264444686

    Enrico Minetti

    Recruiting

  • Azienda Ospedaliero Universitaria di Parma

    Fontevivo, Emilia-Romagna, 43010

    390522000000

    Enrico Fiaccadori

    Recruiting

  • IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino

    Genoa, Liguria, 16132

    390105557162

    Pasquale Esposito

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena

    Modena, Emilia-Romagna, 41124

    390594224136

    Riccardo Magistroni

    Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, Piedmont, 28100

    Withdrawn

  • AUSL Piacenza - Ospedale Guglielmo da Saliceto

    Piacenza, Emilia-Romagna, 29121

    390523302176

    Roberto Scarpioni

    Recruiting

  • Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò

    Ranica, Lombardy, 24020

    +39 0354535309

    Matias Trillini

    Recruiting

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

    390255034583

    Gabroella Moroni

    Recruiting

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara

    Trieste, Friuli Venezia Giulia, 34149

    393489241319

    Vittorio Di Maso

    Recruiting

  • ASL Città di Torino - Ospedale San Giovanni Bosco

    Turin, Piedmont, 10154

    393428507553

    Fenoglio Fenoglio

    Recruiting

Other trials in Italy

Spain12 sites, 12 recruiting

  • Hospital Universitario A Coruña

    A Coruña, Galicia, 15006

    +34636889908

    Catuxa Rodriguez Magarinos

    Recruiting

  • Hospital Universitario Fundacion Alcorcon

    Alcorcón, Madrid, 28922

    +34 916219400

    Eva Lopez Melero

    Recruiting

  • Hospital del Mar

    Barcelona, Catalonia, 8003

    34932483689

    Eva Rodriguez Garcia

    Recruiting

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 8035

    34932746000 ext. 4661

    Maria Jose Soler Romeo

    Recruiting

  • Hospital General San Pedro de Alcantara

    Cáceres, 10003

    34605248551

    Pedro Jesus Labrador Gomez

    Recruiting

  • Hospital Universitario de Getafe

    Getafe, Madrid, 10400

    6622026800

    Judith Fatima Martins Muñoz

    Recruiting

  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

    872987087 ext. 324

    Nadia Martin Alemany

    Recruiting

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

    34915504800 ext. 3325

    Alberto Ortiz Arduan

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    +34 913908208

    Eduardo Gutierrez Martinez

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    34676546066

    Mercedes Lazo Salgueira

    Recruiting

  • Fundacio Puigvert

    Viladecans, Barcelona, 8840

    34934169700

    Helena Marco Rusiñol

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

    34976765624

    Olga Gracia Garcia

    Recruiting

Other trials in Spain

Australia10 sites, 10 recruiting

  • Townsville Hospital

    Douglas, Queensland, 4814

    Recruiting

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029

    Recruiting

  • John Hunter Hospital

    New Lambton, New South Wales, 2305

    Recruiting

  • Concord Repatriation General Hospital

    New South Wales, New South Wales, 2060

    Recruiting

  • Gold Coast University Hospital

    Southport, Queensland, 4215

    Recruiting

  • Griffith University

    Southport, Queensland, 4222

    Recruiting

  • Sunshine Hospital - Australia

    St Albans, Victoria, 3021

    Recruiting

  • Royal North Shore Hospital-Reserve Road

    St Leonards, New South Wales, 2065

    Recruiting

  • Westmead Hospital

    Westmead, New South Wales, 2145

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

    Recruiting

Other trials in Australia

Germany10 sites, 10 recruiting

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117

    4930450614001

    Eva Schrezenmeier

    Recruiting

  • Städtisches Klinikum Braunschweig - Salzdahlumer Straße 90

    Braunschweig, Lower Saxony, 38126

    +49 531 595 2381

    Jan Kielstein

    Recruiting

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, Saxony, 1307

    4935145818825

    Christian Hugo

    Recruiting

  • Universitätsklinikum Frankfurt, Apotheke Haus 19

    Frankfurt am Main, Hesse, 60596

    4969630186463

    Jeannine Lang

    Recruiting

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg, 20246

    +49 152 22802076

    Jule Pinter

    Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    4962215635296

    Claudia Sommerer

    Recruiting

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 4103

    4903419713350

    Jan Kowald

    Recruiting

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

    496131172503

    Julia Weinmann-Menke

    Recruiting

  • Robert Bosch Krankenhaus

    Stuttgart, Baden-Wurttemberg, 70376

    +49 711 8101-3496

    Jörg Latus

    Recruiting

  • Nephrologisches Zentrum Villingen-Schwenningen

    Villingen-Schwenningen, Baden-Wurttemberg, 78052

    4977219985324

    Bernd Hohenstein

    Recruiting

Other trials in Germany

Greece10 sites, 10 recruiting

  • General Hospital of Athens ''G. Gennimatas''

    Athens, Attica, 115 27

    6974466366

    Georgios Moustakas

    Recruiting

  • General Hospital of Athens ''Hippokratio''

    Athens, Attica, 115 27

    302132088375

    Dimitros Petras

    Recruiting

  • Laiko General Hospital of Athens

    Athens, Attica, 11527

    302132061476

    Smaragdi Marinaki

    Recruiting

  • University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA

    Chaïdári, Attica, 12462

    6970178793

    Sophia Lionaki

    Recruiting

  • General Hospital of Heraklion Venizeleio

    Heraklion, Irakleio, 714 09

    306974737879

    Dimitris Xydakis

    Recruiting

  • PAGNI-University General Hospital of Heraklion

    Heraklion, Irakleio, 715 00

    306944025099

    Konstantinos Stylianou

    Recruiting

  • University General Hospital of Ioannina

    Ioannina, 34098

    302651007507

    Evangelia Ntounousi

    Recruiting

  • University General Hospital of Patras

    Pátrai, Achaïa, 26500

    306949548822

    Evangelos Papachristou

    Recruiting

  • AHEPA University General Hospital of Thessaloniki

    Thessaloniki, 54636

    306986670500

    Vassilios Liakopoulos

    Recruiting

  • General Hospital of Thessaloniki ''G. Papanikolaou''

    Thessaloniki, 57010

    306972244472

    Gerasimos Bamichas

    Recruiting

Other trials in Greece

South Korea9 sites, 9 recruiting

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggido, 14068

    Recruiting

  • Pusan National University Hospital

    Busan, Gwangyeogsi, 49241

    Recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620

    Recruiting

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 3722

    Recruiting

  • Hanyang University Seoul Hospital

    Seoul, Seoul Teugbyeolsi, 4763

    Recruiting

  • Seoul National University Hospital

    Seoul, 03080

    Recruiting

  • Samsung Medical Center

    Seoul, 6351

    Recruiting

  • Ajou University Hospital

    Suwon, Gyeonggido, 16499

    Recruiting

Other trials in South Korea

Argentina8 sites, 8 recruiting

  • Hospital Italiano de Buenos Aires

    Almagro, Ciudad Autónoma de BuenosAires, C1199ABB

    541149590200

    Carlos Varela

    Recruiting

  • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS

    Buenos Aires, B1605

    +54 91161732079

    Juan Aurelio De Francesco

    Recruiting

  • DOM Centro de Reumatología

    Buenos Aires, C1111AAH

    + 54 91140613734

    Laurencia Korman Turk

    Recruiting

  • Maffei Centro Médico

    Buenos Aires, C1425

    541148019001

    Maria Smuclir Quevedo

    Not yet recruiting

  • Hospital General de Agudos Dr. Cosme Argerich

    La Boca, Buenos Aires F.D., C1155AHD

    5491131997602

    Raño, Julieta

    Recruiting

  • INECO Neurociencias Oroño

    Rosario, Santa Fe Province, 2000

    +54 341 425-8695

    Dana Miralles

    Recruiting

  • CIMER-Centro Integral de Medicina Respiratoria

    San Miguel de Tucumán, Tucumán Province, T4000CBC

    +54 381 257-7481

    Javier Santiago Alonso

    Recruiting

  • Clínica de Nefrología Urología Y Enfermedades Cardiovasculares

    Santa Fe, 3000

    543424000000

    Mariano Arriola

    Recruiting

Other trials in Argentina

Taiwan8 sites, 8 recruiting

  • National Cheng Kung University Hospital

    Dawan, Taiwan, Province of China, 70403

    Recruiting

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807

    Recruiting

  • Far Eastern Memorial Hospital

    New Taipei City, Taiwan, Province of China, 220216

    Recruiting

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 235041

    Recruiting

  • China Medical University Hospital - PPDS

    Taichung, Taiwan, Province of China, 40447

    Recruiting

  • Mackay Memorial Hospital-Taipei branch

    Taipei, Taiwan, Province of China, 104449

    Recruiting

  • Taipei Municipal Wanfang Hospital

    Taipei, Taiwan, Province of China, 116081

    Recruiting

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan, Taiwan, Province of China, 33305

    Recruiting

Other trials in Taiwan

Turkey (Türkiye)8 sites, 8 recruiting

  • Ankara Bilkent Sehir Hastanesi

    Ankara, Turkey, 34899

    905353665205

    Faith Dede

    Recruiting

  • Akdeniz University Medical Faculty

    Antalya, 7070

    905309672612

    Funda Sari Bahceci

    Recruiting

  • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

    Istanbul, Turkey, 34899

    905303230775

    Izzet Arikan

    Recruiting

  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi Hastanesi

    Istanbul, 34098

    905379535596

    Nurhan Seyahi

    Recruiting

  • Kocaeli Universitesi Arastirma ve Uygulama Hastanesi

    İzmit, Kocaeli, 41380

    +905366301577

    Necmi Eren

    Recruiting

  • Erciyes Universitesi Tip Fakultesi Gevher Nesibe Hastanesi

    Kayseri, 38039

    +905305811661

    Ismail Kocyigit

    Recruiting

  • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi

    Konya, 42090

    9005384927877

    Kultigin Turkmen

    Recruiting

  • Mehmet Akif Inan Egitim ve Arastirma Hastanesi

    Sanliurfa, Turkey, 63040

    905539811595

    Tuncay Sahutoglu

    Recruiting

Other trials in Turkey (Türkiye)

Brazil7 sites, 7 recruiting

  • Freire Pesquisa Clínica

    Belo Horizonte, Minas Gerais, 30150-320

    553138790085

    Rosangela Do Carmo Milagres

    Recruiting

  • Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS

    Belo Horizonte, Minas Gerais, 30150221

    553132388973

    Pedro Macedo de Souz

    Recruiting

  • Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde

    Caxias do Sul, Rio Grande do Sul, 95070-560

    555432182737

    Luciano Da Silva Selistre

    Recruiting

  • Centro Mineiro de Pesquisa - CMiP

    Juiz de Fora, Minas Gerais, 36010

    +55 3233128920

    Barros de Carmo

    Recruiting

  • Hospital de Clinicas de Porto Alegre (HCPA) - PPDS

    Porto Alegre, Rio Grande do Sul, 90035-903

    5199660550

    Cristina Karohl

    Recruiting

  • Hospital Alemao Oswaldo Cruz- HAOC

    São Paulo, 01323-903

    551135490449

    Victor Sato

    Recruiting

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, 05403-000

    551126618238

    Irene Noronha

    Recruiting

Other trials in Brazil

Portugal7 sites, 7 recruiting

  • ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro

    Aveiro, 3814

    +35 1930421587

    Joana Vidinha

    Recruiting

  • Centro Clínico Académico, Braga - Hospital de Braga

    Braga, 4710-243

    +35 125-302-7000

    Raquel Vaz

    Recruiting

  • ULS de Lisboa Ocidental, EPE - Hospital Santa Cruz

    Carnaxide, Lisbon District, 2790

    +35 1210433097

    Eunice Cacheira

    Recruiting

  • ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra

    Coimbra, 3004-561

    351239400400

    Emanuel Ferreira

    Recruiting

  • ULS da Região de Leiria, EPE - Hospital de Santo André

    Leiria, 2410-197

    351244817000

    Joana Silva

    Recruiting

  • ULS da Arrábida, EPE - Hospital de São Bernardo

    Setúbal, 2910-446

    +35 126 554-9048

    Ana Farinha

    Recruiting

  • ULS de Gaia/Espinho, EPE - Unidade I

    Vila Nova de Gaia, Lisbon District, 4434-502

    351227865100

    Ana Gomes

    Recruiting

Other trials in Portugal

Belgium6 sites, 6 recruiting

  • Hôpital Erasme - PPDS

    Anderlecht, Brussels Capital, 1070

    3225556896

    Tess Van Meerhaeghe

    Recruiting

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

    3227647992

    Nathalie Demoulin

    Recruiting

  • ZOL Genk - campus Sint-Jan

    Genk, Limburg, 3600

    +3289802353

    Ben Sprangers

    Not yet recruiting

  • Jan Yperman

    Ieper, West-Vlaanderen, 8900

    3257357297

    Wim Terryn

    Recruiting

  • AZ Groeninge

    Kortrijk, West-Vlaanderen, 8500

    3256633366

    Peter Doubel

    Recruiting

  • UZ Leuven - PPDS

    Leuven, Vlaams Brabant, 3000

    3216345675

    Kathleen Claes

    Recruiting

Other trials in Belgium

Poland6 sites, 6 recruiting

  • Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7

    Gdansk, Pomeranian Voivodeship, 80-952

    48791830095

    Slawomir Lizakowski

    Recruiting

  • MCM Krakow - PRATIA - PPDS

    Krakow, Lesser Poland Voivodeship, 30727

    48122954139

    Przemyslaw Miarka

    Recruiting

  • SCM Clinic - Prywatny Szpital Specjalistyczny

    Krakow, Lesser Poland Voivodeship, 31-559

    +48664802950

    Dariusz Aksamit

    Recruiting

  • SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251

    Lodz, Lódzkie, 92-213

    48422014400

    Michal Nowicki

    Recruiting

  • Twoja Przychodnia - Szczecinskie Centrum Medyczne

    Szczecin, West Pomeranian Voivodeship, 71-434

    48609900745

    Katarzyna Bobrek-Lesiakowska

    Recruiting

  • Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie

    Szczecin, 70-110

    48506688624

    Kazimierz Ciechanowski

    Recruiting

Other trials in Poland

Colombia5 sites, 5 recruiting

  • Clinica de la Costa S.A.S. - PPDS

    Barranquilla, Atlántico, 80020

    Recruiting

  • Fundacion Santa Fe de Bogota - Calle 119 A No. 7 - 49

    Bogotá, Bogota D.C., 110231

    Recruiting

  • Hospital Universitario San Ignacio

    Bogotá, Cundinamarca, 110231

    Recruiting

  • Fundacion Valle Del Lili

    Cali, Valle del Cauca Department, 760032

    Recruiting

  • Healthy Medical Center S.A.S.

    Zipaquirá, Cundinamarca, 250252

    Recruiting

Other trials in Colombia

United Kingdom5 sites, 5 recruiting

  • Leicester General Hospital

    Leicester, Leicestershire, LE5 4PW

    4401162584870

    Chee Kay Cheung

    Recruiting

  • St Pancras Clinical Research

    London, Greater London, EC2Y 8EA

    442038651142

    Muhammad Magdi Yaqoob

    Recruiting

  • Royal Preston Hospital - NWCRN- PPDS

    Preston, Lancashire, PR2 9HT

    441772522031

    Arvind Ponnusamy

    Recruiting

  • Northern General Hospital

    Sheffield, South Yorkshire, S5 7AU

    441142715199

    Salim Arif Khwaja

    Recruiting

  • Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire, ST4 6QG

    441782672724

    Diane (Julie) Wessels

    Recruiting

Other trials in United Kingdom

Bulgaria4 sites, 4 recruiting

  • Medical Center Medconsult Pleven - Lovech Branch

    Lovech, 5500

    359889664169

    Diana Vasileva

    Recruiting

  • Medical Center Hera EOOD, Montana - Hera Clinics - PPDS

    Montana, 3400

    359892308820

    Irena Dimitrova

    Recruiting

  • Medical Center Medconsult Pleven OOD

    Pleven, 5800

    359877243610

    Lazar Garev

    Recruiting

  • University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD-15 Acad. Ivan Geshov Blvd

    Sofia, 1606

    359887802220

    Atanas Kundurdjiev

    Recruiting

Other trials in Bulgaria

Croatia4 sites, 4 recruiting

  • Clinical Hospital Center Rijeka

    Rijeka, 51000

    38551407487

    Ivan Bubic

    Recruiting

  • Special Hospital Medico

    Rijeka, 51000

    385072100700

    Bozidar Vujicic

    Recruiting

  • Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29

    Zagreb, City of Zagreb, 10000

    385912097060

    Tonko Gulin

    Recruiting

  • Polyclinic Bonifarm

    Zagreb, City of Zagreb, 10000

    385915020024

    Ivana Vukovic Brinar

    Recruiting

Other trials in Croatia

Malaysia3 sites, 3 recruiting

  • Hospital Tengku Ampuan Afzan

    Kuantan, Pahang, 25100

    Recruiting

  • University Malaya Medical Centre

    Lembah Pantai, WilayahPersekutuan KualaLumpur, 59100

    Recruiting

  • Hospital Raja Permaisuri Bainun

    Perak, Pahang, 30450

    Recruiting

Other trials in Malaysia

New Zealand3 sites, 3 recruiting

  • Auckland City Hospital

    Auckland, 1023

    Recruiting

  • Aotearoa Clinical Trials Trust- Middlemore Hospital

    Auckland, 2025

    Recruiting

  • Wellington Hospital

    Wellington, 6021

    Recruiting

Other trials in New Zealand

Canada2 sites, 2 recruiting

  • McGill University Health Centre (MUHC)

    Montreal, Quebec, H4A3J1

    5149341934 ext. 35207

    Rita Suri

    Recruiting

  • St Paul's Hospital

    Vancouver, British Columbia, V6Z 1Y6

    6046822344

    Sean Barbour

    Recruiting

Other trials in Canada

Czechia2 sites, 2 recruiting

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, Prague, 128 08

    420224966790

    Vladimir Tesar

    Recruiting

  • Institut klinicke a experimentalni mediciny

    Prague, Praha, Hlavní Mesto, 140 21

    420236052254

    Ondrej Viklicky

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Other trials in Czechia

Philippines2 sites, 2 recruiting

  • Norzel Medical and Diagnostic Clinic Foundation Corp.

    Cebu City, Cebu, 6000

    Recruiting

  • The Medical City - Ortigas Ave - PPDS

    Pasig, Metropolitan Manila, 1604

    Recruiting

Other trials in Philippines

Puerto Rico1 site, 1 recruiting

  • FDI Clinical Research

    San Juan, 00927

    (787) 763-7423

    Jose Cangiano-Rivera

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Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (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:

Read more
  • 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.
Read the detailed description

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.

Being tested
Felzartamab, Placebo
Keywords
Felzartamab
Medical subject headings
Glomerulonephritis, IGA

What participants receive

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

  • FelzartamabDrug

    Also called MOR202, MOR03087, TJ202, HIB202, BIIB148

    Administered IV

  • PlaceboDrug

    Administered IV

Study groups in NCT06935357
Study groupRoleWhat they receive
Cohort 1ExperimentalParticipants will receive several intravenous (IV) doses of felzartamab.
Receives: Drug: Felzartamab
Cohort 2Placebo comparatorParticipants will receive several IV doses of placebo.
Receives: Drug: Placebo
Cohort 3ExperimentalParticipants 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.
Receives: Drug: Felzartamab
Cohort 4Placebo comparatorParticipants with an eGFR ≥ 20 and <30 mL/min/1.73m^2 will receive several IV doses of placebo.
Receives: Drug: Placebo

What is being measured

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

  1. Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)

    Measured: Baseline up to Week 36

Secondary outcomes (12)

  1. Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Values Calculated Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation

    Measured: Baseline up to Week 104

  2. Percentage of Participants Achieving Complete Response (CR)

    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%).

    Measured: Baseline up to Week 104

  3. Percentage of Participants who Progressed to Kidney Malfunction

    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

    Measured: Baseline up to Week 104

  4. Percentage of Participants Requiring Rescue Therapy

    Measured: Baseline up to Week 104

  5. Change From Baseline in eGFR Values Calculated Using the CKD-EPI Creatinine Equation

    Measured: Baseline up to Week 52

  6. Felzartamab Serum Concentrations Over Time

    Measured: Predose and at multiple timepoints postdose up to Week 36

  7. Number of Participants with Anti-Drug Antibodies (ADAs) Against Felzartamab

    Measured: Baseline up to Week 104

  8. Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)

    Measured: Baseline up to Week 104

  9. Number of Participants With Clinically Significant Change From Baseline in Vital Signs Abnormalities

    Measured: Baseline up to Week 104

  10. Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

    Measured: Baseline up to Week 104

  11. Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Abnormalities

    Measured: Baseline up to Week 104

  12. Number of Participants With Clinically Significant Change From Baseline in Physical Examinations Abnormalities

    Measured: Baseline up to Week 104

Timeline

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

  1. First posted20 Apr 2025
  2. Study start8 May 2025
  3. Primary completion31 May 2027 (estimated)
  4. Study completion5 Jun 2029 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
454 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06935357
Sponsor's protocol ID
299IG301
Other IDs
2024-519345-30-00
Acronym
PREVAIL
Status last verified
Oct 2026
First submitted
17 Apr 2025
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Felzartamab in people with Immunoglobulin A Nephropathy (IgAN), run by Biogen at 265 sites in 28 countries.

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

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 265 sites in China, United States, Japan, India, France and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

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

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

Are results available for this study?

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

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

Contact US Biogen Clinical Trial Center (866-633-4636, clinicaltrials@biogen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR) (time frame: Baseline up to Week 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06935357.

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

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

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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