A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Start Date
7/15/2025
Completion Date
1/14/2030
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Mezagitamab
Placebo
Conditions
Locations
UAB Nephrology Research Clinic at Paula Building
Birmingham, Alabama 35233-2110
United States
DCR Montgomery
Montgomery, Alabama 36117
United States
Panoramic Health - Southwest Kidney Institute, PLC
Surprise, Arizona 85374
United States
Panoramic Health - West Coast Kidney Institute (Fremont)
Fremont, California 94538
United States
Academic Medical Research Institute
Los Angeles, California 90022
United States
University of California Irvine
Orange, California 92868-3201
United States
Panoramic Health - Florida Kidney Physicians, LLC (Jacksonville)
Jacksonville, Florida 32250
United States
South Florida Research Institute
Lauderdale Lakes, Florida 33313-1607
United States
Panoramic Health - Florida Kidney Physicians, LLC (Melbourne)
Melbourne, Florida 32901
United States
Bioresearch Partners
Miami, Florida 33127
United States
CTR Oakwater, LLC
Orlando, Florida 32806
United States
Bioresearch Partners
Pembroke Pines, Florida 33029
United States
Panoramic Health - Florida Kidney Physicians, LLC (Tampa)
Riverview, Florida 33578
United States
DCR Columbus
Columbus, Georgia 31904
United States
Panoramic Health - Southeast Kidney Associates
East Point, Georgia 30344
United States
CARE Institute - Boise Kidney
Boise, Idaho 83706
United States
Panoramic Health - RNA of Rockford, LLC dba Rockford Nephrology Associates
Rockford, Illinois 61107
United States
Northwest Louisiana Nephrology
Shreveport, Louisiana 71101
United States
Ingham Nephrology & Hypertension, P.C.
Lansing, Michigan 48911
United States
Elixia MKC
Pontiac, Michigan 48341
United States
Panoramic Health - Lake Michigan Nephrology, PLC
Saint Joseph, Michigan 49085
United States
DCR Edina
Edina, Minnesota 55435
United States
Elixia MNA
City of Saint Peters, Missouri 63376
United States
Clinical Research Consultants a JCCT Company
Kansas City, Missouri 64111
United States
Renal Medicine Associates - Frenova F1
Albuquerque, New Mexico 87109
United States
Brookview Hills Research Associates, LLC
Winston-Salem, North Carolina 27103
United States
Panoramic Health - Kidney and Hypertension Center
Cincinnati, Ohio 45212
United States
Panoramic Health - Clinical Renal Associates, Ltd.
Media, Pennsylvania 19063
United States
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
United States
Panoramic Health - Nephrology Associates, Inc.
East Providence, Rhode Island 02914
United States
Dallas Renal Group
Dallas, Texas 75230
United States
DCR - El Paso
El Paso, Texas 79902
United States
Houston Methodist Research Institute - Department of Medicine
Houston, Texas 77030
United States
Provecta Research Network
Houston, Texas 77054
United States
Nephrology Associates of Houston PLLC
Katy, Texas 77450
United States
Sun Research Institute
San Antonio, Texas 78215
United States
DCR San Antonio
San Antonio, Texas 78251
United States
Utah Kidney Research Institute
Salt Lake City, Utah 84115
United States
Panoramic Health - Virginia Nephrology Group
Arlington, Virginia 22205
United States
West Virginia University
Morgantown, West Virginia 26506
United States
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Ciudad Autonoma de Buenos Aires, Buenos Aires C1425AGC
Argentina
Framingham Centro Medico
Buenos Aires, La Plata 1902
Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, 1280
Argentina
Clinica Privada Velez Sarsfield
Córdoba, X5016
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 3128
Australia
Monash Heath - Monash University - Monash Medical Centre
Clayton, Victoria
Australia
Western Health Sunshine Hospital
St Albans, Victoria 3021
Australia
Johannes Kepler Universitat Linz, Universitatsklinik fur Innere 2
Linz, 4040
Austria
Medizinische Universitat Wien (Medical University of Vienna - Austria)
Vienna, 1090
Austria
Sheldon M. Chumir Health Centre
Calgary, Alberta T2R 0X7
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London Health Sciences Centre
London, Ontario N6A5A5
Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario M4G 3E8
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Peking University First Hospital
Beijing, Beijing Municipality 100034
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Beijing Tsinghua Changgung Hospital
Changping, Beijing Municipality 102218
China
Zhongshan Hospital Xiamen University
Xiamen, Fujian 361004
China
Guangdong General Hospital
Guangzhou, Guangdong 510080
China
Peking University Shenzhen Hospital
Shenzhen, Guangdong 518000
China
The Third Xiangya Hospital of Central South University Yuelu District
Changsha, Hunan 410013
China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia 14010
China
Zhongda Hospital Southeast University
Nanjing, Jiangsu 210009
China
Affiliated Hospital of Nantong University
Nantong, Jiangsu 226001
China
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Wuxi, Jiangsu 214023
China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi 330006
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Jinan, Shandong 250012
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Shanghai Jiao Tong University School of Medicine (SJTUSM) - Renji Hospital - Eastern Branch
Shanghai, Shanghai Municipality 200000
China
Ruijin Hospital of Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality 200025
China
West China Hospital Sichuan University
Chengdu, Sichuan 610000
China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan 610072
China
The Second People's Hospital of Yibin
Yibin, Sichuan 644099
China
The Second Affiliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang
China
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Ningbo, Zhejiang 315010
China
Nemocnice AGEL Novy Jicin a.s
Nový Jičín, Moravskoslezsk Kraj 741 01
Czechia
First Faculty of Medicine Charles University
Prague,
Czechia
Hospital Henri Mondor
Créteil, Paris 94000
France
CHU Bordeaux, CHU Pellegrin
Bordeaux, 33076
France
CHU Limoges Service de Nephrology
Limoges, 87042
France
Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Lapeyronie
Montpellier, 34090
France
CHU de Nantes
Nantes, 44093
France
Hospital Tenon
Paris, 75020
France
Uniklinik RWTH Aachen
Aachen, North Rhine-Westphalia 52074
Germany
Universitaetsklinikum Jena
Jena, Thuringia 7747
Germany
Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
Mainz, 55131
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, 1083
Hungary
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, 25124
Italy
IRCCS Ospedale Policlinico San Martino
Genoa, 16132
Italy
Az Ospedaliera Universitaria Policlinico G Martino
Messina, 98122
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20100
Italy
Istituto Maugeri IRCCS Pavia
Pavia, 27100
Italy
Azienda Unita Sanitaria Locale Piacenza (AUSL) Ospedale "Guglielmo da Saliceto
Piacenza, 29121
Italy
AOU Citta della Salute e della Scienza di Torino
Torino, 10126
Italy
Kasugai Municipal Hospital
Kasugai-Shi, Aichi-ken 486-8510
Japan
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Nagoya, Aichi-ken 466-8650
Japan
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Toyoake-shi, Aichi-ken 470-1192
Japan
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chiba, Chiba 260-8712
Japan
Kyushu University Hospital
Fukuoka, Fukuoka 812-8582
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Fukushima, Fukushima 960-1295
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Hiroshima, Hiroshima 734-8551
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Sapporo, Hokkaido 060-8648
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Shonan Kamakura General Hospital
Kamakura-shi, Kanagawa 247-8533
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Toranomon Hospital Kajigaya
Kawasaki-shi, Kanagawa 213-8587
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Yokohama City University Hospital
Yokohama, Kanagawa 236-0004
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Japan Community Health care Organization Sendai Hospital
Sendai, Miyagi 981-3281
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Nara Medical University Hospital
Kashihara-shi, Nara 634-8522
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Nara Prefecture General Medical Center
Nara, Nara 630-8581
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Oita University Hospital
Yufu-shi, Oita Prefecture 879-5593
Japan
Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofuka
Osaka, Osaka 530-8480
Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya-shi, Saitama 343-8555
Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo 113-8431
Japan
Tokyo Medical University Hospital
Shinjuku-Ku, Tokyo 160-0023
Japan
University of Yamanashi Hospital
Chuo-shi, Yamanashi 409-3898
Japan
Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM))
Kuala Lumpur, Kuala Lumpur 56000
Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Pahang 25100
Malaysia
Hospital Taiping
Taiping, Perak 34000
Malaysia
Hospital Sultan Idris Shah Serdang (Hospital Serdang)
Kajang, Selangor 43000
Malaysia
Sunway Medical Centre (SMC)
Subang Jaya, Selangor 47500
Malaysia
Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
Amsterdam, North Holland 1105 AZ
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Leids Universitair Medisch Center
Leiden, 2333 ZA
Netherlands
Sint Antonius ziekenhuis Utrecht/Nieuwegein
Nieuwegein, 3435CM
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Radboud Universitair Medisch Centrum
Nijmegen, 6525 GA
Netherlands
UMC Utrecht
Utrecht, 3584 CX
Netherlands
Akershus University Hospital
Lorenskog, Akershus 1478
Norway
Sykehuset I Vestfold
Tønsberg, Vestfold
Norway
Haukeland Universitetssjukehus
Bergen, 5021
Norway
Sykehuset Ostfold
Grålum, 1714
Norway
Stavanger Universitetssjukehus - Helse Stavanger HF
Stavanger,
Norway
Universitetssykehuset I Trondheim - St. Olavs Hospital - Nevroklinikken
Trondheim, 7030
Norway
Nowy Szpital Sp Zo.o
Gmina Świecie, 86-100
Poland
SCM Sp. z o.o.
Krakow, 31-559
Poland
Indywidualna Specjalistyczna Praktyka Lekarska
Lodz,
Poland
4th Military Clinical hospital /Polyclinic SP ZOZ
Wroclaw, 50-981
Poland
Singapore General Hospital
Singapore, 169608
Singapore
Tan Tock Seng Hospital
Singapore, 308433
Singapore
National University Hospital
Singapore,
Singapore
University Medical Centre Ljubljana
Ljubljana, 1000
Slovenia
University Clinical Centre Maribor
Maribor,
Slovenia
Ajou University Hospital-Primary Research Location
Suwon, Gyeonggido 16499
South Korea
Seoul National University Bundang Hospital
Seongnam-si, Seongnam 13620
South Korea
Seoul National University Hospital
Seoul, 3080
South Korea
Seoul National University Boramae Medical Center
Seoul, 7061
South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona 8915
Spain
Hospital Universitario de Cruces
Barakaldo, Bizkaia 48903
Spain
Universidad de Navarra - Clinica Universidad de Navarra
Pamplona, Navarre 31008
Spain
Hospital del Mar
Barcelona, 8003
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 8035
Spain
Universidad de Navarra - Clinica Universidad de Navarra
Madrid, 28027
Spain
Fundacion Jimenez Diaz
Madrid, 28040
Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
Spain
Renal Medicine Linkoping University/ Linkoping University Hospital
Linköping,
Sweden
University Hospital Zurich
Zurich, 8091
Switzerland
Kaohsiung Medical University - Chung-Ho Memorial Hospital
Kaohsiung City, 807
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Taipei Medical University Shuang Ho Hospital
New Taipei City,
Taiwan
Taichung Veterans General Hospital
Taichung, 40705
Taiwan
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Taichung,
Taiwan
National Taiwan University Hospital
Zhongzheng, 100
Taiwan
Turgut Ozal Medical Center
Malatya, Battalgazi 44280
Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Şahinbey, Gaziantep 27310
Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa Tip Fakultesi
Fatih, Istanbul 34098
Turkey (Türkiye)
Erciyes University
Kayseri, Melikgazi 38039
Turkey (Türkiye)
Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Avsar Mah
Kahramanmaraş, Onikisubat 46040
Turkey (Türkiye)
Necmettin Erbakan University
Konya, Selcuklu 42280
Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi
Kocaeli,
Turkey (Türkiye)
Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
London, Greater London SE1 9RT
United Kingdom
Birmingham Heartlands Hospital
Birmingham, United Kingdom of Great Britain and Northern Ireland
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Kent & Canterbury Hospital, Canterbury
Canterbury, CT1 3PA
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Hull University Teaching Hospitals NHS Trust
Hull,
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Leicester General Hospital
Leicester,
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St George's University Hospitals NHS Foundation Trust
London, SW17 0QT
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King's College Hospital
London, WC2R 2LS
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Nottingham University Hospitals NHS Trust - City Hospital
Nottingham,
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Lancashire Teaching Hospital NHS Foundation Trust
Preston, PR29HT
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Northern General Hospital
Sheffield,
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