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A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Sponsor: Takeda
Summary
Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo. Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed by chance in either the mezagitamab or placebo treatment group at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. Participants can be in the study for 2 years (104 weeks). Participants will receive study treatment for about half a year (22 weeks) and then be observed for the remainder of the study (about 1.5 years). During observation, participants will continue to have check-ups about every month. In the open-label group, a small number of participants who either have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab. During the study, participants will visit their study clinic several times.
Official title: A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
347
Start Date
2025-07-15
Completion Date
2030-01-14
Last Updated
2026-10-23
Healthy Volunteers
No
Conditions
Interventions
Mezagitamab
Mezagitamab injections administered SC.
Placebo
Mezagitamab-matching placebo injections administered SC.
Locations (181)
UAB Nephrology Research Clinic at Paula Building
Birmingham, Alabama, United States
DCR Montgomery
Montgomery, Alabama, United States
Panoramic Health - Southwest Kidney Institute, PLC
Surprise, Arizona, United States
Panoramic Health - West Coast Kidney Institute (Fremont)
Fremont, California, United States
Academic Medical Research Institute
Los Angeles, California, United States
UCLA University of California Los Angeles
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
Kaiser Permanente San Francisco Medical Center
San Francisco, California, United States
Panoramic Health - Florida Kidney Physicians, LLC (Jacksonville)
Jacksonville, Florida, United States
South Florida Research Institute
Lauderdale Lakes, Florida, United States
Panoramic Health - Florida Kidney Physicians, LLC (Melbourne)
Melbourne, Florida, United States
Bioresearch Partners
Miami, Florida, United States
CTR Oakwater, LLC
Orlando, Florida, United States
Bioresearch Partners
Pembroke Pines, Florida, United States
Panoramic Health - Florida Kidney Physicians, LLC (Tampa)
Riverview, Florida, United States
DCR Columbus
Columbus, Georgia, United States
Panoramic Health - Southeast Kidney Associates
East Point, Georgia, United States
CARE Institute - Boise Kidney
Boise, Idaho, United States
Northwestern University
Chicago, Illinois, United States
Panoramic Health - RNA of Rockford, LLC dba Rockford Nephrology Associates
Rockford, Illinois, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States
Ingham Nephrology & Hypertension, P.C.
Lansing, Michigan, United States
Elixia MKC
Pontiac, Michigan, United States
Panoramic Health - Lake Michigan Nephrology, PLC
Saint Joseph, Michigan, United States
DCR Edina
Edina, Minnesota, United States
Elixia MNA
City of Saint Peters, Missouri, United States
Clinical Research Consultants a JCCT Company
Kansas City, Missouri, United States
Renal Medicine Associates - Frenova F1
Albuquerque, New Mexico, United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, United States
Panoramic Health - Kidney and Hypertension Center
Cincinnati, Ohio, United States
Panoramic Health - Clinical Renal Associates, Ltd.
Media, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Panoramic Health - Nephrology Associates, Inc.
East Providence, Rhode Island, United States
Dallas Renal Group
Dallas, Texas, United States
DCR - El Paso
El Paso, Texas, United States
Houston Methodist Research Institute - Department of Medicine
Houston, Texas, United States
Provecta Research Network
Houston, Texas, United States
Nephrology Associates of Houston PLLC
Katy, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
DCR San Antonio
San Antonio, Texas, United States
Utah Kidney Research Institute
Salt Lake City, Utah, United States
Panoramic Health - Virginia Nephrology Group
Arlington, Virginia, United States
West Virginia University
Morgantown, West Virginia, United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Framingham Centro Medico
Buenos Aires, La Plata, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Clinica Privada Velez Sarsfield
Córdoba, Argentina
South Western Sydney Local Health District - University of New South Wales - Liverpool Hospital
Liverpool, New South Wales, Australia
Core Research Group
Milton, Queensland, Australia
Eastern Health
Box Hill, Victoria, Australia
Monash Heath - Monash University - Monash Medical Centre
Clayton, Victoria, Australia
Western Health Sunshine Hospital
St Albans, Victoria, Australia
Johannes Kepler Universitat Linz, Universitatsklinik fur Innere 2
Linz, Austria
Medizinische Universitat Wien (Medical University of Vienna - Austria)
Vienna, Austria
Sheldon M. Chumir Health Centre
Calgary, Alberta, Canada
London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Changping, Beijing Municipality, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The Third Xiangya Hospital of Central South University Yuelu District
Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shandong University - Qilu Hospital
Jinan, Shandong, China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Renji Hospital - Eastern Branch
Shanghai, Shanghai Municipality, China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Second People's Hospital of Yibin
Yibin, Sichuan, China
The Second Affiliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Nemocnice AGEL Novy Jicin a.s
Nový Jičín, Moravskoslezsk Kraj, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
First Faculty of Medicine Charles University
Prague, Czechia
Hospital Henri Mondor
Créteil, Paris, France
CHU Bordeaux, CHU Pellegrin
Bordeaux, France
CHU Limoges Service de Nephrology
Limoges, France
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Lapeyronie
Montpellier, France
CHU de Nantes
Nantes, France
Hospital Tenon
Paris, France
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia, Germany
Universitaetsklinikum Jena
Jena, Thuringia, Germany
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, Germany
The University of Hong Kong - Department of Medicine
Hong Kong, Hong Kong Island, Hong Kong
Semmelweis Egyetem - Belgyogyaszati es Onkologiai Klinika (I.sz. Belgyogyaszati Klinika)
Budapest, Hungary
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Italy
IRCCS Ospedale Policlinico San Martino
Genoa, Italy
Az Ospedaliera Universitaria Policlinico G Martino
Messina, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Istituto Maugeri IRCCS Pavia
Pavia, Italy
Azienda Unita Sanitaria Locale Piacenza (AUSL) Ospedale "Guglielmo da Saliceto
Piacenza, Italy
AOU Citta della Salute e della Scienza di Torino
Torino, Italy
Kasugai Municipal Hospital
Kasugai-Shi, Aichi-ken, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan