A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)

Status: Recruiting
Location: See all (137) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arkansas
Applied Research Center of Arkansas
RECRUITING
Little Rock
California
Kidney & Hypertension Center - Apple Valley
RECRUITING
Apple Valley
Scripps Green Hospital
NOT_YET_RECRUITING
Carlsbad
FOMAT Medical Research - FOMAT - PPDS
RECRUITING
Oxnard
North America Research Institute-San Dimas
RECRUITING
San Dimas
Florida
Nova Clinical Research, LLC
RECRUITING
Bradenton
Royal Research, Corp.
RECRUITING
Hollywood
Central Florida Kidney Specialists
RECRUITING
Orlando
Georgia
American Clinical Trials LLC
RECRUITING
Acworth
Massachusetts
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Michigan
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
RECRUITING
Pontiac
Missouri
Midwest Nephrology Associates,Inc.
WITHDRAWN
City Of Saint Peters
New York
James J Peters Veterans Administration Medical Center - NAVREF - PPDS
RECRUITING
The Bronx
Tennessee
Knoxville Kidney Center, PLLC
RECRUITING
Knoxville
Texas
Texas Kidney Institute - Dallas
RECRUITING
Dallas
Provecta Research Network
RECRUITING
Houston
R & H Clinical Research
RECRUITING
Katy
Other Locations
Argentina
Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
RECRUITING
Buenos Aires
DOM Centro de Reumatología
NOT_YET_RECRUITING
Buenos Aires
INECO Neurociencias Oroño
NOT_YET_RECRUITING
Rosario
CIMER-Centro Integral de Medicina Respiratoria
NOT_YET_RECRUITING
San Miguel De Tucumán
Australia
John Hunter Hospital
NOT_YET_RECRUITING
New Lambton
Concord Repatriation General Hospital
RECRUITING
New South Wales
Westmead Hospital
RECRUITING
Westmead
Belgium
ZOL Genk - campus Sint-Jan
NOT_YET_RECRUITING
Genk
AZ Groeninge
RECRUITING
Kortrijk
UZ Leuven - PPDS
RECRUITING
Leuven
Brazil
Freire Pesquisa Clínica
NOT_YET_RECRUITING
Belo Horizonte
Centro Mineiro de Pesquisa - CMiP
NOT_YET_RECRUITING
Juiz De Fora
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
RECRUITING
São Paulo
Bulgaria
Medical Center Medconsult Pleven - Lovech Branch
RECRUITING
Lovech
Medical Center Hera EOOD, Montana - Hera Clinics - PPDS
RECRUITING
Montana
Medical Center Medconsult Pleven OOD
RECRUITING
Pleven
Canada
McGill University Health Centre (MUHC)
NOT_YET_RECRUITING
Montreal
China
Beijing Tsinghua Changgung Hospital
NOT_YET_RECRUITING
Beijing
Peking University First Hospital - Changqiao Campus
RECRUITING
Beijing
Cangzhou Central Hospital
RECRUITING
Cangzhou
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
RECRUITING
Chengdu
Fu Yang People's Hospital - South Campus
RECRUITING
Fuyang
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
Qilu Hospital of Shandong University
RECRUITING
Jinan
Jinhua Municipal Central Hospital
RECRUITING
Jinhua
Gansu Provincial Hospital
RECRUITING
Lanzhou
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
RECRUITING
Luoyang
The Second Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Jiading Central Hospital
RECRUITING
Shanghai
Shanghai General Hospital - North Campus
RECRUITING
Shanghai
The Second Hospital of Hebei Medical University - Main
RECRUITING
Shijiazhuang
Taizhou Hospital of Zhejiang Province - Main
RECRUITING
Taizhou
Wuxi Peoples Hospital
RECRUITING
Wuxi
Yichang Central People's Hospital - Wujiagang Campus
RECRUITING
Yichang
Colombia
Clinica de la Costa S.A.S. - PPDS
NOT_YET_RECRUITING
Barranquilla
Healthy Medical Center S.A.S.
NOT_YET_RECRUITING
Zipaquirá
Croatia
Polyclinic Bonifarm
NOT_YET_RECRUITING
Zagreb
France
CHU de Besançon
RECRUITING
Besançon
CHU de Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
AP-HP - Hôpital Henri Mondor
RECRUITING
Créteil
CHU Amiens Picardie - Site Sud
RECRUITING
Dreuil-lès-amiens
Centre Hospitalier Departemental de Vendee
RECRUITING
La Roche-sur-yon
GHRMSA - Hôpital Emile Muller
RECRUITING
Mulhouse
CHU de Nîmes - Hopital Universitaire Caremeau
RECRUITING
Nîmes Cédex 9
CHRU d'Orleans- Hôpital de La Source
RECRUITING
Orléans
AP-HP - Hôpital Saint-Louis
RECRUITING
Paris
AP-HP - Hopital Tenon
RECRUITING
Paris
CHU de Reims - Hôpital Maison Blanche
NOT_YET_RECRUITING
Reims
CHU de Strasbourg - Nouvel Hôpital Civil
RECRUITING
Strasbourg
Hopital Foch
RECRUITING
Suresnes
Germany
Charité - Universitätsmedizin Berlin
NOT_YET_RECRUITING
Berlin
Universitätsklinikum Frankfurt, Apotheke Haus 19
RECRUITING
Frankfurt Am Main
Nephrologisches Zentrum Villingen-Schwenningen
NOT_YET_RECRUITING
Villingen-schwenningen
India
Zydus Hospital
RECRUITING
Ahmedabad
M.S. Ramaiah Medical College and Hospital
RECRUITING
Bangalore
Osmania General Hospital
RECRUITING
Hyderabad
Government Medical College, Kozhikode
NOT_YET_RECRUITING
Kozhikode
Sir Ganga Ram Hospital
NOT_YET_RECRUITING
New Delhi
Noble Hospital
RECRUITING
Pune
All India Institute of Medical Sciences ( AIIMS ) - Raipur
NOT_YET_RECRUITING
Raipur
Trivandrum Medical College Hospital
NOT_YET_RECRUITING
Trivandrum
Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
NOT_YET_RECRUITING
Brescia
Azienda Ospedaliero Universitaria Maggiore della Carità
NOT_YET_RECRUITING
Novara
AUSL Piacenza - Ospedale Guglielmo da Saliceto
RECRUITING
Piacenza
Centro di Ricerche Cliniche per le Malattie Rare Aldo e Cele Daccò
RECRUITING
Ranica
Japan
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
RECRUITING
Chiba
Fukushima Medical University Hospital
RECRUITING
Fukushima
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Ikeda Municipal Hospital
RECRUITING
Ikeda-shi
Toranomon Hospital Kajigaya
RECRUITING
Kawasaki-shi
Hospital of the University of Occupational and Environmental Health, Japan
RECRUITING
Kitakyushu-shi
Kawasaki Medical School Hospital
RECRUITING
Kurashiki
University Hospital, Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
Kitasato University Hospital
RECRUITING
Sagamihara-shi
Hokkaido University Hospital
RECRUITING
Sapporo
Tohoku Medical and Pharmaceutical University Hospital
RECRUITING
Sendai
Showa Medical University Hospital
RECRUITING
Shinagawa-ku
Osaka University Hospital
RECRUITING
Suita-shi
Fujita Health University Hospital
RECRUITING
Toyoake-shi
Juntendo University Urayasu Hospital
RECRUITING
Urayasu-shi
Yokohama City University Hospital
RECRUITING
Yokohama
Malaysia
Hospital Tengku Ampuan Afzan
RECRUITING
Kuantan
University Malaya Medical Centre
RECRUITING
Lembah Pantai
Hospital Raja Permaisuri Bainun
RECRUITING
Perak
Poland
MCM Krakow - PRATIA - PPDS
RECRUITING
Krakow
SCM Clinic - Prywatny Szpital Specjalistyczny
RECRUITING
Krakow
Twoja Przychodnia - Szczecinskie Centrum Medyczne
RECRUITING
Szczecin
Portugal
ULS da Região de Aveiro, EPE - Hospital Infante D. Pedro
RECRUITING
Aveiro
Centro Clínico Académico, Braga - Hospital de Braga
RECRUITING
Braga
ULS de Lisboa Ocidental, EPE - Hospital Santa Cruz
RECRUITING
Carnaxide
ULS da Região de Leiria, EPE - Hospital de Santo André
NOT_YET_RECRUITING
Leiria
ULS da Arrábida, EPE - Hospital de São Bernardo
RECRUITING
Setúbal
Puerto Rico
FDI Clinical Research
RECRUITING
San Juan
Republic of Korea
Hallym University Sacred Heart Hospital
RECRUITING
Anyang-si
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Pusan National University Hospital
RECRUITING
Busan
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital Yonsei University Health System
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Spain
Hospital Universitario A Coruña
RECRUITING
A Coruña
Hospital Universitario Fundacion Alcorcon
RECRUITING
Alcorcón
Hospital Universitario Vall d'Hebron - PPDS
NOT_YET_RECRUITING
Barcelona
Hospital General San Pedro de Alcantara
NOT_YET_RECRUITING
Cáceres
Hospital Universitario de Getafe
RECRUITING
Getafe
Hospital Universitari de Girona Dr Josep Trueta
RECRUITING
Girona
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Taiwan
National Cheng Kung University Hospital
RECRUITING
Dawan
Kaohsiung Medical University - Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
Far Eastern Memorial Hospital
NOT_YET_RECRUITING
New Taipei City
Taipei Medical University Shuang Ho Hospital
RECRUITING
New Taipei City
China Medical University Hospital - PPDS
NOT_YET_RECRUITING
Taichung
Mackay Memorial Hospital-Taipei branch
RECRUITING
Taipei
Taipei Municipal Wanfang Hospital
NOT_YET_RECRUITING
Taipei
United Kingdom
Leicester General Hospital
RECRUITING
Leicester
Royal Preston Hospital - NWCRN- PPDS
RECRUITING
Preston
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
Contact Information
Primary
US Biogen Clinical Trial Center
clinicaltrials@biogen.com
866-633-4636
Backup
Global Biogen Clinical Trial Center
clinicaltrials@biogen.com
Time Frame
Start Date: 2025-05-08
Estimated Completion Date: 2029-06-05
Participants
Target number of participants: 454
Treatments
Experimental: Cohort 1
Participants will receive several intravenous (IV) doses of felzartamab.
Placebo_comparator: Cohort 2
Participants will receive several IV doses of placebo.
Experimental: 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.
Placebo_comparator: Cohort 4
Participants with an eGFR ≥ 20 and \<30 mL/min/1.73m\^2 will receive several IV doses of placebo.
Related Therapeutic Areas
Sponsors
Leads: Biogen
Collaborators: Human Immunology Biosciences, Inc. (HI-Bio)

This content was sourced from clinicaltrials.gov