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Recruiting Phase 3 NCT06935357

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

Phase 3 – large-scale trial before approval
Conditions: Immunoglobulin A Nephropathy (IgAN)

Sponsor: Biogen

trial.available_in: БГ
Overview
In this study, researchers will learn more about the use of felzartamab in participants with immunoglobulin A nephropathy (IgAN). 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.
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.
Who can participate
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, biopsy confirmation of IgAN diagnosis must be done within the past 24 months prior to signing the ICF. * An eGFR ≥ 30 mL/min/1.73m\^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and \< 30 mL/min/1.73m\^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, or intolerant of ACEI or ARB. If intolerant, this must be discussed with the Medical Monitor prior to randomization. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is), endothelin receptor antagonists (ERAs) approved for the treatment of IgAN, 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 sparsentan will not be permitted to use simultaneous ACEI or ARB medication. Key Exclusion Criteria: * 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. * Nephrotic syndrome presumed to be due to minimal change disease (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 corticosteroids exposure (\> 7.5 milligrams per deciliter \[mg/d\] prednisone/prednisolone equivalent) within 4 months (or 12 months for rituximab) prior to Screening. * 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 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.
Interventions
Felzartamab
DRUG
Placebo
DRUG
Locations 227
Argentina (6)
Hospital Italiano de Buenos Aires
Almagro , Ciudad Autónoma de BuenosAires
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
Buenos Aires
DOM Centro de Reumatología
Buenos Aires
Maffei Centro Médico
Buenos Aires
NOT_YET_RECRUITING
INECO Neurociencias Oroño
Rosario , Santa Fe Province
CIMER-Centro Integral de Medicina Respiratoria
San Miguel de Tucumán , Tucumán Province
Australia (7)
Townsville Hospital
Douglas , Queensland
John Hunter Hospital
New Lambton , New South Wales
Concord Repatriation General Hospital
New South Wales , New South Wales
Gold Coast University Hospital
Southport , Queensland
Griffith University
Southport , Queensland
Sunshine Hospital - Australia
St Albans , Victoria
NOT_YET_RECRUITING
Westmead Hospital
Westmead , New South Wales
Belgium (6)
Hôpital Erasme - PPDS
Anderlecht , Brussels Capital
Cliniques Universitaires Saint-Luc
Brussels
ZOL Genk - campus Sint-Jan
Genk , Limburg
NOT_YET_RECRUITING
Jan Yperman
Ieper , West-Vlaanderen
AZ Groeninge
Kortrijk , West-Vlaanderen
UZ Leuven - PPDS
Leuven , Vlaams Brabant
Brazil (7)
Freire Pesquisa Clínica
Belo Horizonte , Minas Gerais
Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS
Belo Horizonte , Minas Gerais
Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
Caxias do Sul , Rio Grande do Sul
Centro Mineiro de Pesquisa - CMiP
Juiz de Fora , Minas Gerais
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre , Rio Grande do Sul
Hospital Alemao Oswaldo Cruz- HAOC
São Paulo
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo
Bulgaria (4)
Medical Center Medconsult Pleven - Lovech Branch
Lovech
Medical Center Hera EOOD, Montana - Hera Clinics - PPDS
Montana
Medical Center Medconsult Pleven OOD
Pleven
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD-15 Acad. Ivan Geshov Blvd
Sofia
Canada (2)
McGill University Health Centre (MUHC)
Montreal , Quebec
NOT_YET_RECRUITING
St Paul's Hospital
Vancouver , British Columbia
NOT_YET_RECRUITING
China (31)
Peking University First Hospital - Changqiao Campus
Beijing , Beijing Municipality
Beijing Tsinghua Changgung Hospital
Beijing , Beijing Municipality
Cangzhou Central Hospital
Cangzhou , Hebei
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu , Sichuan
Daqing Oilfield General Hospital
Daqing , Heilongjiang
Fu Yang People's Hospital - South Campus
Fuyang , Anhui
Fujian Medical University Union Hospital
Fuzhou , Fujian
The First Affiliated Hospital of Guangzhou Medical University - Yanjiang Campus
Guangzhou , Guangdong
The Affiliated Hospital of Guizhou Medical University
Guiyang , Guizhou
The First Affiliated Hospital of Anhui Medical University - Jixilu Campus
Hefei , Anhui
Qilu Hospital of Shandong University
Jinan , Shandong
The Second Hospital of Shandong University
Jinan , Shandong
Jinhua Municipal Central Hospital
Jinhua , Zhejiang
Gansu Provincial Hospital
Lanzhou , Gansu
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
Luoyang , Henan
The Second Affiliated Hospital of Nanjing Medical University
Nanjing , Jiangsu
The First Affiliated Hospital of Guangxi Medical University
Nanning , Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning , Guangxi
Affiliated Hospital of Nantong University
Nantong , Jiangsu
Shanghai General Hospital - North Campus
Shanghai , Shanghai Municipality
Jiading Central Hospital
Shanghai , Shanghai Municipality
Shenzhen Hospital of Southern Medical University
Shenzhen , Guangdong
Peking University Shenzhen Hospital
Shenzhen , Guangdong
The Second Hospital of Hebei Medical University - Main
Shijiazhuang , Hebei
The Third Hospital of Hebei Medical University
Shijiazhuang , Hebei
Taizhou Hospital of Zhejiang Province - Main
Taizhou , Zhejiang
Wuxi Peoples Hospital
Wuxi , Jiangsu
Zhongshan Hospital Xiamen University
Xiamen , Fujian
Yantai Yuhuangding Hospital
Yantai , Shandong
NOT_YET_RECRUITING
Yichang Central People's Hospital - Wujiagang Campus
Yichang , Hubei
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan , Guangdong
Colombia (3)
Clinica de la Costa S.A.S. - PPDS
Barranquilla , Atlántico
NOT_YET_RECRUITING
Fundacion Valle Del Lili
Cali , Valle del Cauca Department
NOT_YET_RECRUITING
Healthy Medical Center S.A.S.
Zipaquirá , Cundinamarca
NOT_YET_RECRUITING
Croatia (4)
Clinical Hospital Center Rijeka
Rijeka
Special Hospital Medico
Rijeka
Klinicki bolnicki centar Sestre Milosrdnice - Vinogradska cesta 29
Zagreb , City of Zagreb
Polyclinic Bonifarm
Zagreb , City of Zagreb
Czech Republic (1)
Institut klinicke a experimentalni mediciny
Prague , Praha, Hlavní Mesto
France (13)
CHU de Besançon
Besançon , Dobus
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux , Gironde
AP-HP - Hôpital Henri Mondor
Créteil , Val-de-Marne
CHU Amiens Picardie - Site Sud
Dreuil-lès-Amiens
Centre Hospitalier Departemental de Vendee
La Roche-sur-Yon , Vendée
GHRMSA - Hôpital Emile Muller
Mulhouse , Haut-Rhin
CHU de Nîmes - Hopital Universitaire Caremeau
Nîmes Cédex 9 , Occitanie
CHRU d'Orleans- Hôpital de La Source
Orléans , Loiret
AP-HP - Hôpital Saint-Louis
Paris
AP-HP - Hopital Tenon
Paris
CHU de Reims - Hôpital Maison Blanche
Reims , Grand Est
CHU de Strasbourg - Nouvel Hôpital Civil
Strasbourg , Bas-Rhin
Hopital Foch
Suresnes , Hauts-de-Seine
Germany (5)
Charité - Universitätsmedizin Berlin
Berlin
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden , Saxony
Universitätsklinikum Frankfurt, Apotheke Haus 19
Frankfurt am Main , Hesse
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz , Rhineland-Palatinate
Nephrologisches Zentrum Villingen-Schwenningen
Villingen-Schwenningen , Baden-Wurttemberg
Greece (8)
General Hospital of Athens ''G. Gennimatas''
Athens , Attica
General Hospital of Athens ''Hippokratio''
Athens , Attica
Laiko General Hospital of Athens
Athens , Attica
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA
Chaïdári , Attica
General Hospital of Heraklion Venizeleio
Heraklion , Irakleio
PAGNI-University General Hospital of Heraklion
Heraklion , Irakleio
University General Hospital of Ioannina
Ioannina
AHEPA University General Hospital of Thessaloniki
Thessaloniki
India (17)
Zydus Hospital
Ahmedabad , Gujarat
Manipal Hospital Bangalore
Bangalore , Karnataka
NOT_YET_RECRUITING
M.S. Ramaiah Medical College and Hospital
Bangalore , Karnataka
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh
NOT_YET_RECRUITING
Osmania General Hospital
Hyderabad , Andhra Pradesh
Nizams Institute of Medical Sciences
Hyderabad , Andhra Pradesh
Nil Ratan Sircar Medical College and Hospital
Kolkata , West Bengal
Government Medical College, Kozhikode
Kozhikode , Kerala
King George Medical University
Lucknow , Uttar Pradesh
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow , Uttar Pradesh
Seth G S Medical College and K E M Hospital
Mumbai , Maharashtra
Muljibhai Patel Society for Research in Nephro-Urology
Nadiād , Gujarat
Max Super Speciality Hospital - Saket
New Delhi , National Capital Territory of Delhi
Sir Ganga Ram Hospital
New Delhi , National Capital Territory of Delhi
Noble Hospital
Pune , Maharashtra
All India Institute of Medical Sciences ( AIIMS ) - Raipur
Raipur , Chhattisgarh
Trivandrum Medical College Hospital
Trivandrum , Kerala
NOT_YET_RECRUITING
Italy (7)
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia , Lombardy
IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino
Genoa , Liguria
NOT_YET_RECRUITING
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara , Piedmont
WITHDRAWN
AUSL Piacenza - Ospedale Guglielmo da Saliceto
Piacenza , Emilia-Romagna
Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò
Ranica , Lombardy
IRCCS Istituto Clinico Humanitas
Rozzano , Lombardy
NOT_YET_RECRUITING
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - Ospedale di Cattinara
Trieste , Friuli Venezia Giulia
Japan (22)
The Jikei University West Medical Center
Ashikaga-Shi , Tokyo
Juntendo University Hospital
Bunkyo-Ku , Tokyo
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chiba , Chiba
Fukushima Medical University Hospital
Fukushima , Hukusima
Hamamatsu University Hospital
Hamamatsu , Sizouka
Hirosaki University Hospital
Hirosaki-shi , Aomori
Ikeda Municipal Hospital
Ikeda-shi , Ôsaka
Nara Medical University Hospital
Kashihara , Nara
Toranomon Hospital Kajigaya
Kawasaki-shi , Kanagawa
Hospital of the University of Occupational and Environmental Health, Japan
Kitakyushu-shi , Hukuoka
Kawasaki Medical School Hospital
Kurashiki , Okayama-ken
University Hospital, Kyoto Prefectural University of Medicine
Kyoto , Kyôto
Jikei University Hospital
Minato-ku , Tokyo
Kitasato University Hospital
Sagamihara-shi , Kanagawa
Hokkaido University Hospital
Sapporo , Hokkaido
Tohoku Medical and Pharmaceutical University Hospital
Sendai , Miyagi
Showa Medical University Hospital
Shinagawa-ku , Tokyo
Osaka University Hospital
Suita-shi , Ôsaka
Tokushima University Hospital
Tokushima , Tokushima
Fujita Health University Hospital
Toyoake-shi , Aiti
Juntendo University Urayasu Hospital
Urayasu-Shi , Chiba
Yokohama City University Hospital
Yokohama , Kanagawa
Malaysia (3)
Hospital Tengku Ampuan Afzan
Kuantan , Pahang
University Malaya Medical Centre
Lembah Pantai , WilayahPersekutuan KualaLumpur
Hospital Raja Permaisuri Bainun
Perak , Pahang
New Zealand (2)
Aotearoa Clinical Trials Trust- Middlemore Hospital
Auckland
NOT_YET_RECRUITING
Wellington Hospital
Wellington
NOT_YET_RECRUITING
Philippines (1)
Norzel Medical and Diagnostic Clinic Foundation Corp.
Cebu City , Cebu
Poland (6)
Uniwersyteckie Centrum Kliniczne w Gdansku - Debinki 7
Gdansk , Pomeranian Voivodeship
MCM Krakow - PRATIA - PPDS
Krakow , Lesser Poland Voivodeship
SCM Clinic - Prywatny Szpital Specjalistyczny
Krakow , Lesser Poland Voivodeship
SPZOZ Centralny Szpital Kliniczny UM w Lodzi - ul. Pomorska 251
Lodz , Lódzkie
NOT_YET_RECRUITING
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin , West Pomeranian Voivodeship
Uniwersytecki Szpital Kliniczny Nr 2 PUM w Szczecinie
Szczecin
Portugal (7)
ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
Aveiro
Centro Clínico Académico, Braga - Hospital de Braga
Braga
ULS de Lisboa Ocidental, EPE - Hospital Santa Cruz
Carnaxide , Lisbon District
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra
Coimbra
ULS da Região de Leiria, EPE - Hospital de Santo André
Leiria
ULS da Arrábida, EPE - Hospital de São Bernardo
Setúbal
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia , Lisbon District
Puerto Rico (1)
FDI Clinical Research
San Juan
South Korea (9)
Hallym University Sacred Heart Hospital
Anyang-si , Gyeonggido
Inje University Haeundae Paik Hospital
Busan
Pusan National University Hospital
Busan , Gwangyeogsi
Seoul National University Bundang Hospital
Seongnam-si , Gyeonggido
Seoul National University Hospital
Seoul
Samsung Medical Center
Seoul
Severance Hospital Yonsei University Health System
Seoul , Seoul Teugbyeolsi
Hanyang University Seoul Hospital
Seoul , Seoul Teugbyeolsi
Ajou University Hospital
Suwon , Gyeonggido
Spain (12)
Hospital Universitario A Coruña
A Coruña , Galicia
Hospital Universitario Fundacion Alcorcon
Alcorcón , Madrid
Hospital del Mar
Barcelona , Catalonia
Hospital Universitario Vall d'Hebron - PPDS
Barcelona
Hospital General San Pedro de Alcantara
Cáceres
Hospital Universitario de Getafe
Getafe , Madrid
Hospital Universitari de Girona Dr Josep Trueta
Girona
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Virgen Macarena
Seville
Fundacio Puigvert
Viladecans , Barcelona
Hospital Universitario Miguel Servet
Zaragoza
Taiwan (8)
National Cheng Kung University Hospital
Dawan , Taiwan, Province of China
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City
Far Eastern Memorial Hospital
New Taipei City , Taiwan, Province of China
Taipei Medical University Shuang Ho Hospital
New Taipei City
China Medical University Hospital - PPDS
Taichung , Taiwan, Province of China
Mackay Memorial Hospital-Taipei branch
Taipei , Taiwan, Province of China
Taipei Municipal Wanfang Hospital
Taipei , Taiwan, Province of China
Chang Gung Memorial Hospital, Linkou
Taoyuan District , Taiwan, Province of China
Turkey (7)
Ankara Bilkent Sehir Hastanesi
Ankara , Turkey
Akdeniz University Medical Faculty
Antalya
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul , Turkey
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi Hastanesi
Istanbul
Kocaeli Universitesi Arastirma ve Uygulama Hastanesi
İzmit , Kocaeli
Erciyes Universitesi Tip Fakultesi Gevher Nesibe Hastanesi
Kayseri
Mehmet Akif Inan Egitim ve Arastirma Hastanesi
Sanliurfa , Turkey
NOT_YET_RECRUITING
United Kingdom (3)
Leicester General Hospital
Leicester , Leicestershire
Royal Preston Hospital - NWCRN- PPDS
Preston , Lancashire
Royal Stoke University Hospital
Stoke-on-Trent , Staffordshire
United States (25)
American Clinical Trials LLC
Acworth , Georgia
WITHDRAWN
Kidney & Hypertension Center - Apple Valley
Apple Valley , California
The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital
Boston , Massachusetts
Brigham and Women's Hospital
Boston , Massachusetts
Nova Clinical Research, LLC
Bradenton , Florida
Anointed Nephrology and HTN - SKYCRNG - PPDS
Brookhaven , Mississippi
Scripps Green Hospital
Carlsbad , California
Midwest Nephrology Associates,Inc.
City of Saint Peters , Missouri
WITHDRAWN
Texas Kidney Institute - Dallas
Dallas , Texas
Henry Ford Hospital
Detroit , Michigan
NOT_YET_RECRUITING
University of Florida - Gainesville - 1600 SW Archer Rd
Gainesville , Florida
NOT_YET_RECRUITING
National Institute of clinical Research Administration Office
Garden Grove , California
WITHDRAWN
Royal Research, Corp.
Hollywood , Florida
Provecta Research Network
Houston , Texas
R & H Clinical Research
Katy , Texas
Knoxville Kidney Center, PLLC
Knoxville , Tennessee
Applied Research Center of Arkansas
Little Rock , Arkansas
Central Florida Kidney Specialists
Orlando , Florida
FOMAT Medical Research - FOMAT - PPDS
Oxnard , California
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac , Michigan
WITHDRAWN
CDC Research Institute, LLC
Port Saint Lucie , Florida
Lifespan at Rhode Island Hospital
Providence , Rhode Island
North America Research Institute-San Dimas
San Dimas , California
James J Peters Veterans Administration Medical Center - NAVREF - PPDS
The Bronx , New York
UMass Memorial Medical Center
Worcester , Massachusetts
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
08.05.2025
Completion date
05.06.2029
Registry ID
NCT06935357
Source
clinicaltrials.gov
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