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A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition
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 in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time. In the open-label group, a small number of participants who 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
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Mezagitamab
Mezagitamab injections administered SC.
Placebo
Mezagitamab-matching placebo injections administered SC.
Locations (140)
UAB Nephrology Research Clinic at Paula Building
Birmingham, Alabama, United States
DCR Montgomery
Montgomery, Alabama, United States
Academic Medical Research Institute
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
South Florida Research Institute
Lauderdale Lakes, Florida, United States
Bioresearch Partners
Miami, Florida, United States
CTR Oakwater, LLC
Orlando, Florida, United States
Bioresearch Partners
Pembroke Pines, Florida, United States
DCR Columbus
Columbus, Georgia, United States
CARE Institute - Boise Kidney
Boise, Idaho, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, United States
Ingham Nephrology & Hypertension, P.C.
Lansing, Michigan, United States
Elixia MKC
Pontiac, 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
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 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
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
Core Research Group
Milton, Queensland, 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
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
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
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 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
Kasugai Municipal Hospital
Kasugai-Shi, Aichi-ken, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University Hospital
Toyoake-shi, Aichi-ken, Japan
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chiba, Chiba, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa, Japan
Toranomon Hospital Kajigaya
Kawasaki-shi, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Japan Community Health care Organization Sendai Hospital
Sendai, Miyagi, Japan
Nara Medical University Hospital
Kashihara-shi, Nara, Japan
Nara Prefecture General Medical Center
Nara, Nara, Japan
Oita University Hospital
Yufu-shi, Oita Prefecture, Japan
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofuka
Osaka, Osaka, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo, Japan
University of Yamanashi Hospital
Chuo-shi, Yamanashi, Japan
Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM))
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang, Malaysia
Hospital Taiping
Taiping, Perak, Malaysia
Hospital Sultan Idris Shah Serdang (Hospital Serdang)
Kajang, Selangor, Malaysia
Sunway Medical Centre (SMC)
Subang Jaya, Selangor, Malaysia
Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
Amsterdam, North Holland, Netherlands
Sint Antonius ziekenhuis Utrecht/Nieuwegein
Nieuwegein, Netherlands
UMC Utrecht
Utrecht, Netherlands
Akershus University Hospital
Lorenskog, Akershus, Norway
Sykehuset I Vestfold
Tønsberg, Vestfold, Norway
Haukeland Universitetssjukehus
Bergen, Norway
Sykehuset Ostfold
Grålum, Norway
Stavanger Universitetssjukehus - Helse Stavanger HF
Stavanger, Norway
Universitetssykehuset I Trondheim - St. Olavs Hospital - Nevroklinikken
Trondheim, Norway
Nowy Szpital Sp Zo.o
Gmina Świecie, Poland
SCM Sp. z o.o.
Krakow, Poland
4th Military Clinical hospital /Polyclinic SP ZOZ
Wroclaw, Poland
National University Hospital
Singapore, Singapore
Singapore General Hospital
Singapore, Singapore
Tan Tock Seng Hospital
Singapore, Singapore
University Medical Centre Ljubljana
Ljubljana, Slovenia
Ajou University Hospital-Primary Research Location
Suwon, Gyeonggido, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Seongnam, South Korea
Seoul National University Hospital
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Universidad de Navarra - Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital del Mar
Barcelona, Spain
Universidad de Navarra - Clinica Universidad de Navarra
Madrid, Spain
Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain
Renal Medicine Linkoping University/ Linkoping University Hospital
Linköping, Sweden
University Hospital Zurich
Zurich, Switzerland
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Taipei Medical University Shuang Ho Hospital
New Taipei City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital
Zhongzheng, Taiwan
Turgut Ozal Medical Center
Malatya, Battalgazi, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Şahinbey, Gaziantep, Turkey (Türkiye)
Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Avsar Mah
Kahramanmaraş, Onikisubat, Turkey (Türkiye)
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, Greater London, United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom
Kent & Canterbury Hospital, Canterbury
Canterbury, United Kingdom
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
Leicester General Hospital
Leicester, United Kingdom
St George's University Hospitals NHS Foundation Trust
London, United Kingdom
King's College Hospital
London, United Kingdom