A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy

May 19, 2026 updated by: Takeda

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

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.

Study Overview

Status

Recruiting

Conditions

Kidney Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

347

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Takeda Contact
Phone Number: +1-877-825-3327
Email: medinfoUS@takeda.com

Study Locations

Argentina
- - Ciudad Autonoma Buenos Aires, Argentina, 1280
    - Recruiting
    - Hospital Britanico de Buenos Aires
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Hernan Trimarchi Jurado
  - Córdoba, Argentina, X5016
    - Recruiting
    - Clínica Privada Vélez Sarsfield
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Rafael Alberto Maldonado
- Buenos Aires
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425AGC
    - Recruiting
    - Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Alejandra Smuclir Quevedo
- La Plata
  - Buenos Aires, La Plata, Argentina, 1902
    - Recruiting
    - Framingham Centro Medico
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Martin Mamberti
Australia
- Queensland
  - Milton, Queensland, Australia, 4046
    - Recruiting
    - Core Research Group
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      David Colquhoun
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Recruiting
    - Eastern Health
    - Principal Investigator:
      
      Darren Lee
    - Contact:
      
      Site Contact
  - St Albans, Victoria, Australia, 3021
    - Recruiting
    - Western Health Sunshine Hospital
    - Principal Investigator:
      
      Eugenia Pedagogos
    - Contact:
      
      Site Contact
Austria
- - Linz, Austria, 4040
    - Recruiting
    - Johannes Kepler Universitat Linz, Universitatsklinik fur Innere 2
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Alexander Moschen
  - Vienna, Austria, 1090
    - Recruiting
    - Medizinische Universitat Wien (Medical University of Vienna - Austria)
    - Principal Investigator:
      
      Rainer Oberbauer
    - Contact:
      
      Site Contact
Canada
- Alberta
  - Calgary, Alberta, Canada, T2R 0X7
    - Recruiting
    - Sheldon M. Chumir Health Centre
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Louis Girard
China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100034
    - Recruiting
    - Peking University First Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Jicheng Lv
  - Changping, Beijing Municipality, China, 102218
    - Recruiting
    - Beijing Tsinghua Changgung Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Yuehong Li
- Fujian
  - Xiamen, Fujian, China, 361004
    - Recruiting
    - Zhongshan Hospital Xiamen University
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Bo Xu
- Guangdong
  - Guangzhou, Guangdong, China, 510080
    - Recruiting
    - Guangdong General Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Zhiming Ye
  - Shenzhen, Guangdong, China, 518000
    - Recruiting
    - Peking University Shenzhen Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Zu-Ying Xiong
- Hunan
  - Changsha, Hunan, China, 410013
    - Recruiting
    - The Third Xiangya Hospital of Central South University Yuelu District
    - Principal Investigator:
      
      Hao Zhang
    - Contact:
      
      Site Contact
- Inner Mongolia
  - Baotou, Inner Mongolia, China, 14010
    - Recruiting
    - The First Affiliated Hospital of Baotou Medical College
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Zengyan Li
- Jiangsu
  - Nanjing, Jiangsu, China, 210009
    - Recruiting
    - Zhongda Hospital Southeast University
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Liu Bicheng
  - Nantong, Jiangsu, China, 226001
    - Recruiting
    - Affiliated Hospital of Nantong University
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Xinzhong Huang
  - Wuxi, Jiangsu, China, 214023
    - Recruiting
    - Wuxi People's Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Liang Wang
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Recruiting
    - The First Affiliated Hospital of Nanchang University
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Yan Yan
- Shandong
  - Jinan, Shandong, China, 250012
    - Recruiting
    - Shandong University - Qilu Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Xiang-Dong Yang
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200000
    - Recruiting
    - Shanghai Jiao Tong University School of Medicine (SJTUSM) - Renji Hospital - Eastern Branch
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Leyi Gu
  - Shanghai, Shanghai Municipality, China, 200025
    - Recruiting
    - Ruijin Hospital of Shanghai Jiaotong University School of Medicine
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Jingyuan Xie
- Sichuan
  - Chengdu, Sichuan, China, 610000
    - Recruiting
    - West China Hospital Sichuan University
    - Principal Investigator:
      
      Ping Fu
    - Contact:
      
      Site Contact
  - Chengdu, Sichuan, China, 610072
    - Recruiting
    - Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Guisen Li
  - Yibin, Sichuan, China, 644099
    - Recruiting
    - The Second People's Hospital Of Yibin
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Deqiong Xie
- Zhejiang
  - Hangzhou, Zhejiang, China, 310009
    - Recruiting
    - The Second Affiliated Hospital, Zhejiang University, School of Medicine
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Kunling Ma
  - Ningbo, Zhejiang, China, 315010
    - Recruiting
    - The first affiliated Hospital of Ningbo University
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Xueyan Bian
Czechia
- - Prague, Czechia, 128 01
    - Recruiting
    - First Faculty of Medicine Charles University
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Vladimir Tesar
- Moravskoslezsk Kraj
  - Nový Jičín, Moravskoslezsk Kraj, Czechia, 741 01
    - Recruiting
    - Nemocnice AGEL Novy Jicin a.s
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Vaclava Honova
France
- - Bordeaux, France, 33076
    - Recruiting
    - CHU Bordeaux, CHU Pellegrin
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Claire Rigothier
  - Limoges, France, 87042
    - Recruiting
    - CHU Limoges Service de Nephrology
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Fatouma Toure
  - Montpellier, France, 34090
    - Recruiting
    - Centre Hospitalier Universitaire de Montpellier (CHU Montpellier) - Hopital Lapeyronie
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Moglie Le Quintrec
  - Nantes, France, 44093
    - Recruiting
    - CHU de Nantes
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Simon VILLE
  - Paris, France, 75020
    - Recruiting
    - Hospital Tenon
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Khalil Karoui
- Paris
  - Créteil, Paris, France, 94000
    - Recruiting
    - Hospital Henri Mondor
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Vincent Audard
Germany
- - Mainz, Germany, 55131
    - Recruiting
    - Universitaetsmedizin der Johannes - Gutenberg Universitaet Mainz
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Julia Weinmann-Manke
- North Rhine-Westphalia
  - Aachen, North Rhine-Westphalia, Germany, 52074
    - Recruiting
    - Uniklinik RWTH Aachen
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Claudia Seikrit
- Thuringia
  - Jena, Thuringia, Germany, 7747
    - Recruiting
    - Universitaetsklinikum Jena
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Martin Busch
Hong Kong
- Hong Kong Island
  - Hong Kong, Hong Kong Island, Hong Kong
    - Recruiting
    - The University of Hong Kong - Department of Medicine
    - Principal Investigator:
      
      Sydney Chi Wai Tang
    - Contact:
      
      Site Contact
Hungary
- - Budapest, Hungary, 1083
    - Recruiting
    - Semmelweis Egyetem - Belgyogyaszati es Onkologiai Klinika (I.sz. Belgyogyaszati Klinika)
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Akos Petho
Italy
- - Bologna, Italy, 40138
    - Recruiting
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Gaetano La Manna
  - Brescia, Italy, 25124
    - Recruiting
    - ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Federica Mescia
  - Genoa, Italy, 16132
    - Recruiting
    - IRCCS Ospedale Policlinico San Martino
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Francesca Viazzi
  - Messina, Italy, 98122
    - Recruiting
    - Az Ospedaliera Universitaria Policlinico G Martino
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Domenico Santoro
  - Milan, Italy, 20100
    - Recruiting
    - Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Giuseppe Castellano
  - Pavia, Italy, 27100
    - Recruiting
    - Istituto Maugeri IRCCS Pavia
    - Principal Investigator:
      
      Ciro Esposito
    - Contact:
      
      Site Contact
  - Piacenza, Italy, 29121
    - Recruiting
    - Azienda Unita Sanitaria Locale Piacenza (AUSL) Ospedale "Guglielmo da Saliceto
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Roberto Scarpioni
Japan
- Aichi-ken
  - Kasugai-Shi, Aichi-ken, Japan, 486-8510
    - Recruiting
    - Kasugai Municipal Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Yosuke Saka
  - Nagoya, Aichi-ken, Japan, 466-8650
    - Recruiting
    - Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Shoji Saito
  - Toyoake-shi, Aichi-ken, Japan, 470-1192
    - Recruiting
    - Fujita Health University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Naotake Tsuboi
- Chiba
  - Chiba, Chiba, Japan, 260-8712
    - Recruiting
    - National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Takehiko Kawaguchi
- Fukuoka
  - Fukuoka, Fukuoka, Japan, 812-8582
    - Recruiting
    - Kyushu University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Toshiaki Nakano
- Fukushima
  - Fukushima, Fukushima, Japan, 960-1295
    - Recruiting
    - Fukushima Medical University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Kazama Junichiro
- Hiroshima
  - Hiroshima, Hiroshima, Japan, 734-8551
    - Recruiting
    - Hiroshima University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Takao Masaki
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Recruiting
    - Hokkaido University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Daigo Nakazawa
- Kanagawa
  - Kamakura-shi, Kanagawa, Japan, 247-8533
    - Recruiting
    - Shonan Kamakura General Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Hidaka Sumi
  - Kawasaki-shi, Kanagawa, Japan, 213-8587
    - Recruiting
    - Toranomon Hospital Kajigaya
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Naoki Sawa
  - Yokohama, Kanagawa, Japan, 236-0004
    - Recruiting
    - Yokohama City University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Kouichi Tamura
- Miyagi
  - Sendai, Miyagi, Japan, 981-3281
    - Recruiting
    - Japan Community Health care Organization Sendai Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Santoru Sanada
- Nara
  - Kashihara-shi, Nara, Japan, 634-8522
    - Recruiting
    - Nara Medical University Hospital
    - Principal Investigator:
      
      Kazuhiko Tsuruya
    - Contact:
      
      Site Contact
  - Nara, Nara, Japan, 630-8581
    - Recruiting
    - Nara Prefecture General Medical Center
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Hideo Tsushima
- Oita Prefecture
  - Yufu-shi, Oita Prefecture, Japan, 879-5593
    - Recruiting
    - Oita University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Fukuda Akihiro
- Osaka
  - Osaka, Osaka, Japan, 530-8480
    - Recruiting
    - Medical Research Institute KITANO HOSPITAL, PIIF Tazuke-Kofuka
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Takeshi Matsubara
- Saitama
  - Koshigaya-shi, Saitama, Japan, 343-8555
    - Recruiting
    - Dokkyo Medical University Saitama Medical Center
    - Principal Investigator:
      
      Tetsuro Takeda
    - Contact:
      
      Site Contact
- Tokyo
  - Bunkyo-ku, Tokyo, Japan, 113-8431
    - Recruiting
    - Juntendo University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Yusuke Suzuki
  - Shinjuku-Ku, Tokyo, Japan, 160-0023
    - Recruiting
    - Tokyo Medical University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Takahito Moriyama
- Yamanashi
  - Chuo-shi, Yamanashi, Japan, 409-3898
    - Recruiting
    - University of Yamanashi Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Ayumu Nakashima
Malaysia
- Kuala Lumpur
  - Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
    - Recruiting
    - Universiti Kebangsaan Malaysia (UKM) - Medical Centre (Pusat Perubatan) (Hospital Canselor Tuanku Muhriz (HCTM))
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Lydia Kamaruzaman
- Pahang
  - Kuantan, Pahang, Malaysia, 25100
    - Recruiting
    - Hospital Tengku Ampuan Afzan
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Fariz Safhan Mohamad Nor
- Perak
  - Taiping, Perak, Malaysia, 34000
    - Recruiting
    - Hospital Taiping
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Kok Seng Teng
- Selangor
  - Kajang, Selangor, Malaysia, 43000
    - Recruiting
    - Hospital Sultan Idris Shah Serdang (Hospital Serdang)
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Li Lian Tay
  - Subang Jaya, Selangor, Malaysia, 47500
    - Recruiting
    - Sunway Medical Centre (SMC)
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Rosnawati Yahya
Netherlands
- - Leiden, Netherlands, 2333 ZA
    - Recruiting
    - Leids Universitair Medisch Center
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Joris Rotmans
  - Nieuwegein, Netherlands, 3435CM
    - Recruiting
    - Sint Antonius ziekenhuis Utrecht/Nieuwegein
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Gurbey Ocak
  - Nijmegen, Netherlands, 6525 GA
    - Recruiting
    - Radboud Universitair Medisch Centrum
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Raphael Duivenvoorden
  - Utrecht, Netherlands, 3584 CX
    - Recruiting
    - UMC Utrecht
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Sabine Meijvis
- North Holland
  - Amsterdam, North Holland, Netherlands, 1105 AZ
    - Recruiting
    - Amsterdam UMC - Locatie AMC (Academisch Medisch Centrum)
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Marc Hilhorst
Norway
- - Bergen, Norway, 5021
    - Recruiting
    - Haukeland Universitetssjukehus
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Thomas Knoop
  - Grålum, Norway, 1714
    - Recruiting
    - Sykehuset Ostfold
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Dumitrescu Ioana-Elena
  - Stavanger, Norway
    - Recruiting
    - Stavanger Universitetssjukehus - Helse Stavanger HF
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Goransson Lasse
  - Trondheim, Norway, 7030
    - Recruiting
    - Universitetssykehuset I Trondheim - St. Olavs Hospital - Nevroklinikken
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Yngvar Haaskjold
- Akershus
  - Lorenskog, Akershus, Norway, 1478
    - Recruiting
    - Akershus University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Bartlomiej Witczak
- Vestfold
  - Tønsberg, Vestfold, Norway, 4011
    - Recruiting
    - Sykehuset i Vestfold
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Kjellevold Stig Arne
Poland
- - Gmina Świecie, Poland, 86-100
    - Recruiting
    - Nowy Szpital Sp Zo.o
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Andrzej Brymora
  - Krakow, Poland, 31-559
    - Recruiting
    - SCM Sp. z o.o.
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Dariusz Aksamit
  - Lodz, Poland
    - Recruiting
    - Indywidualna Specjalistyczna Praktyka Lekarska
    - Principal Investigator:
      
      Michal Nowicki
    - Contact:
      
      Site Contact
  - Wroclaw, Poland, 50-981
    - Recruiting
    - 4th Military Clinical hospital /Polyclinic SP ZOZ
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Magdalena Krajewska
Singapore
- - Singapore, Singapore, 169608
    - Recruiting
    - Singapore General Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Jason Choo
  - Singapore, Singapore, 308433
    - Recruiting
    - Tan Tock Seng Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      See Cheng Yeo
  - Singapore, Singapore, 119074
    - Recruiting
    - National University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Boon Wee Teo
Slovenia
- - Ljubljana, Slovenia, 1000
    - Recruiting
    - University Medical Centre Ljubljana
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Andreja Ales Rigler
  - Maribor, Slovenia, 2000
    - Recruiting
    - University Clinical Centre Maribor
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Sebastjan Bevc
South Korea
- - Seoul, South Korea, 3080
    - Recruiting
    - Seoul National University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Dong Ki Kim
  - Seoul, South Korea, 7061
    - Recruiting
    - Seoul National University Boramae Medical Center
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Jung Pyo Lee
- Gyeonggido
  - Suwon, Gyeonggido, South Korea, 16499
    - Recruiting
    - Ajou University Hospital-Primary Research Location
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Inwhee Park
- Seongnam
  - Seongnam-si, Seongnam, South Korea, 13620
    - Recruiting
    - Seoul National University Bundang Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Ho-Jun Chin
Spain
- - Barcelona, Spain, 8003
    - Recruiting
    - Hospital del Mar
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Eva Rodriguez Garcia
  - Madrid, Spain, 28040
    - Recruiting
    - Fundacion Jimenez Diaz
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Roberto Scarpioni
  - Madrid, Spain, 28027
    - Recruiting
    - Universidad de Navarra - Clinica Universidad de Navarra
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Jose Maria Mora Gutierrez
  - Seville, Spain, 41013
    - Recruiting
    - Hospital Universitario Virgen del Rocio - PPDS
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Manuel Lopez Mendoza
- Barcelona
  - Badalona, Barcelona, Spain, 8915
    - Recruiting
    - Hospital Universitari Germans Trias i Pujol
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Iara Karlla Da Silva Santos
- Navarre
  - Pamplona, Navarre, Spain, 31008
    - Recruiting
    - Universidad de Navarra - Clinica Universidad de Navarra
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Jose Maria Mora Gutierrez
Sweden
- - Linköping, Sweden, SE-581 85
    - Recruiting
    - Renal Medicine Linkoping University/ Linkoping University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Annette Bruchfeld
Switzerland
- - Zurich, Switzerland, 8091
    - Recruiting
    - University Hospital Zürich
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Britta George
Taiwan
- - Kaohsiung City, Taiwan, 807
    - Recruiting
    - Kaohsiung Medical University - Chung-Ho Memorial Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Yi Wen Chiu
  - New Taipei City, Taiwan, 23561
    - Recruiting
    - Taipei Medical University Shuang Ho Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Mai-Szu Wu
  - Taichung, Taiwan, 40705
    - Recruiting
    - Taichung Veterans General Hospital
    - Principal Investigator:
      
      Ming-Ju Wu
    - Contact:
      
      Site Contact
  - Taichung, Taiwan, 40447
    - Recruiting
    - China Medical University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Ping-Chin Lai
  - Zhongzheng, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Jenq-Wen Huang
Turkey (Türkiye)
- Battalgazi
  - Malatya, Battalgazi, Turkey (Türkiye), 44280
    - Recruiting
    - Turgut Ozal Medical Center
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Ozkan Ulutas
- Gaziantep
  - Şahinbey, Gaziantep, Turkey (Türkiye), 27310
    - Recruiting
    - Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Fatih Mehmet Erdur
- Istanbul
  - Fatih, Istanbul, Turkey (Türkiye), 34098
    - Recruiting
    - Istanbul Universitesi Cerrahpasa Tip Fakultesi
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Nurhan Seyahi
- Onikisubat
  - Kahramanmaraş, Onikisubat, Turkey (Türkiye), 46040
    - Recruiting
    - Kahramanmaras Sutcu Imam Universitesi Tip Fakultesi Avsar Mah
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Orcum Altunoren
- Selcuklu
  - Konya, Selcuklu, Turkey (Türkiye), 42280
    - Recruiting
    - Necmettin Erbakan University
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Kultigin Turkmen
United Kingdom
- - Birmingham, United Kingdom, B95SS
    - Recruiting
    - Birmingham Heartlands Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Bamidele Tokunbo Ajayi
  - Canterbury, United Kingdom, CT1 3PA
    - Recruiting
    - Kent & Canterbury Hospital, Canterbury
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Tharindra Somasinghe
  - Hull, United Kingdom, HU3 2JZ
    - Recruiting
    - Hull University Teaching Hospitals NHS Trust
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Sunil Bhandari
  - Leicester, United Kingdom, LE5 4PW
    - Recruiting
    - Leicester General Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Chee Kay Cheung
  - London, United Kingdom, WC2R 2LS
    - Recruiting
    - King's College Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Sapna Shah
  - London, United Kingdom, SW17 0QT
    - Recruiting
    - St George's University Hospitals NHS Foundation Trust
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Richard Hull
  - Nottingham, United Kingdom, NG5 1PB
    - Recruiting
    - Nottingham University Hospitals NHS Trust - City Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Matthew Hall
- Greater London
  - London, Greater London, United Kingdom, SE1 9RT
    - Recruiting
    - Guy's and St Thomas' NHS Foundation Trust - Guy's Hospital
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Dimitrios-Anestis Moutzouris
United States
- Alabama
  - Birmingham, Alabama, United States, 35233-2110
    - Recruiting
    - UAB Nephrology Research Clinic at Paula Building
    - Principal Investigator:
      
      Dana Rizk
    - Contact:
      
      Site Contact
  - Montgomery, Alabama, United States, 36117
    - Recruiting
    - DCR Montgomery
    - Principal Investigator:
      
      Vinayak Ramanath
    - Contact:
      
      Site Contact
- Arizona
  - Surprise, Arizona, United States, 85374
    - Recruiting
    - Panoramic Health - Southwest Kidney Institute, PLC
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Minesh Rajpal
- California
  - Fremont, California, United States, 94538
    - Recruiting
    - Panoramic Health - West Coast Kidney Institute (Fremont)
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Varun Chawla
  - Los Angeles, California, United States, 90022
    - Recruiting
    - Academic Medical Research Institute
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Mohammed El-Shahwy
  - Orange, California, United States, 92868-3201
    - Recruiting
    - University of California Irvine
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Ramy Hanna
- Florida
  - Lauderdale Lakes, Florida, United States, 33313-1607
    - Recruiting
    - South Florida Research Institute
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Edouard Martin
  - Melbourne, Florida, United States, 32901
    - Recruiting
    - Panoramic Health - Florida Kidney Physicians, LLC (Melbourne)
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Claus Peter Spies
  - Miami, Florida, United States, 33127
    - Recruiting
    - Bioresearch Partners
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Jose Miguel Cardona-Guzman
  - Orlando, Florida, United States, 32806
    - Recruiting
    - CTR Oakwater, LLC
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Arvind Madan
  - Pembroke Pines, Florida, United States, 33029
    - Recruiting
    - Bioresearch Partners
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Max Benjamin
  - Riverview, Florida, United States, 33578
    - Recruiting
    - Panoramic Health - Florida Kidney Physicians, LLC (Tampa)
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Amit Augustine Johnsingh
- Georgia
  - Columbus, Georgia, United States, 31904
    - Recruiting
    - DCR Columbus
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Tamorie Smith
- Idaho
  - Boise, Idaho, United States, 83706
    - Recruiting
    - CARE Institute - Boise Kidney
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Arnold Silva
- Illinois
  - Rockford, Illinois, United States, 61107
    - Recruiting
    - Panoramic Health - RNA of Rockford, LLC dba Rockford Nephrology Associates
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Syed Mustafa Ahmed
- Louisiana
  - Shreveport, Louisiana, United States, 71101
    - Recruiting
    - Northwest Louisiana Nephrology
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Marwan Kaskas
- Michigan
  - Lansing, Michigan, United States, 48911
    - Recruiting
    - Ingham Nephrology & Hypertension, P.C.
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Brian Cousino
  - Pontiac, Michigan, United States, 48341
    - Recruiting
    - Elixia MKC
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Fahd Al-Saghir
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Recruiting
    - DCR Edina
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Shannon Doyle
- Missouri
  - City of Saint Peters, Missouri, United States, 63376
    - Recruiting
    - Elixia MNA
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Gary Singer
  - Kansas City, Missouri, United States, 64111
    - Recruiting
    - Clinical Research Consultants a JCCT Company
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Ahmed Awad
- North Carolina
  - Winston-Salem, North Carolina, United States, 27103
    - Recruiting
    - Brookview Hills Research Associates, LLC
    - Principal Investigator:
      
      Nicholas McLean
    - Contact:
      
      Site Contact
- Pennsylvania
  - Media, Pennsylvania, United States, 19063
    - Recruiting
    - Panoramic Health - Clinical Renal Associates, Ltd.
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Nathan Okechukwu
  - Philadelphia, Pennsylvania, United States, 19107
    - Recruiting
    - Thomas Jefferson University
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Charlene Deng
- Rhode Island
  - East Providence, Rhode Island, United States, 02914
    - Recruiting
    - Panoramic Health - Nephrology Associates, Inc.
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Larissa Kruger Gomes
- Texas
  - Dallas, Texas, United States, 75230
    - Recruiting
    - Dallas Renal Group
    - Principal Investigator:
      
      Irfan Agha
    - Contact:
      
      Site Contact
  - El Paso, Texas, United States, 79902
    - Recruiting
    - DCR - El Paso
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Simon Rodriguez
  - Houston, Texas, United States, 77054
    - Recruiting
    - Provecta Research Network
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Sreedhar Mandayam
  - Houston, Texas, United States, 77030
    - Recruiting
    - Houston Methodist Research Institute - Department of Medicine
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Peter Nguyen
  - Katy, Texas, United States, 77450
    - Recruiting
    - Nephrology Associates of Houston PLLC
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Syed Hussain
  - San Antonio, Texas, United States, 78215
    - Recruiting
    - Sun Research Institute
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Reyes Leonel
  - San Antonio, Texas, United States, 78251
    - Recruiting
    - DCR San Antonio
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Tahira Alves
- Utah
  - Salt Lake City, Utah, United States, 84115
    - Recruiting
    - Utah Kidney Research Institute
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Sanjiv Anand
- West Virginia
  - Morgantown, West Virginia, United States, 26506
    - Recruiting
    - West Virginia University
    - Contact:
      
      Site Contact
    - Principal Investigator:
      
      Bethany Pellegrino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

To be eligible to participate in this trial, participants must meet all the following criteria:

Either UPCR greater than or equal to (≥) 0.8 gram per gram (g/g) or urine protein excretion (UPE) ≥1 grams per day (g/day), calculated from at least one 24-hour urine collection during the screening period (or pre-screening, if applicable) (only applicable for the main trial).
eGFR greater than (>)30 milliliters per minute per 1.73 meter square (mL/min/1.73m^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).
No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for open-label cohort participants meeting Inclusion Criterion No. 10.a).
The participant is aged ≥ 18 years or the local legal age as applicable.
The participant (and the participant's legally acceptable representative, as applicable per local regulations or determination) has provided informed consent (that is, in writing, documented via a signed and dated informed consent form [ICF]) and any required privacy authorization before the initiation of any clinical trial procedures.
Diagnosis of primary immunoglobulin A nephropathy (IgAN) supported by a renal biopsy report that is dated more recently than 10 years before the signing of the informed consent for the clinical trial. The redacted report must be made available for review. A renal biopsy must be performed during screening for participants without a biopsy report within 10 years.
Participants must be on stable renin-angiotensin-aldosterone system (RAAS) inhibitor therapy with an angiotensin-converting enzyme inhibitor (ACE-I) and/or angiotensin receptor blocker (ARB) or endothelin receptor antagonist (ERA) or mineralocorticoid receptor antagonist (MRA) agent for at least 12 weeks before signing the ICF with dosing at the maximally tolerated or labeled dose as determined by the investigator, with the intent to continue stable dosing during the clinical trial. Those intolerant of RAAS inhibitor therapy are potentially eligible after consultation with the medical monitor. Intolerance is defined as a documented side effect causing discontinuation of the therapy.
Resting blood pressure less than or equal to (≤)150 millimeters of mercury (mmHg) systolic and ≤100 mmHg diastolic.
Female participants of childbearing potential who are not pregnant during screening (confirmed by negative serum human chorionic gonadotropin [hCG]) and on Visit 1 before first dose of trial intervention (confirmed by negative urine pregnancy test).
Any one of the following (only applicable for participants in the open-label cohort):
1. Participants in Trial TAK-079-1006 who completed the Week 96 visit or the retreatment period with either UPCR >0.5 g/g or UPE >0.5 g/d calculated from a 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR >30 mL/min/1.73m^2 at screening based on the CKD-EPI formula.
2. UPCR <0.8 g/g and UPE ≥0.75 and <1.0 g/day, by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR > 30 mL/min/1.73m^2 at screening based on the CKD-EPI formula.
3. UPCR ≥ 0.8 g/g or UPE ≥ 1.0 g/d by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR ≥25 and ≤30 mL/min/1.73m^2 at screening based on the CKD-EPI formula.
  - Exclusion Criteria:

A participant who meets any of the following criteria will be excluded from participation in this trial:

Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change disease).
Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A (IgA) vasculitis.
Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).
Diagnosis of nephrotic syndrome defined as 24-hour proteinuria >3.5 g/day and hypoalbuminemia (<3.0 grams per deciliter [g/dL]) with or without peripheral edema.
Renal or other organ transplantation prior to or expected during the clinical trial.
Treatment with oral immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, cyclosporine, azathioprine, calcineurin inhibitors) or biologic therapy for immunomodulation (including immunomodulatory monoclonal or polyclonal antibodies) within 6 months (both B-cell and non-B-cell directed agents) before signing of the ICF.
If the participant has received anti-CD20 treatment, the participant is excluded if either of the following apply:
1. The last dose was received within 6 months before the signing of the ICF.
2. The last dose was received between 6 and 12 months before the signing of the ICF and the participant has a CD19+ count below the lower limit of normal.
Note: Participants who have received the last dose of anti-CD20 treatment >12 months before the signing of the ICF are not excluded from clinical trial participation based on this criterion and are not required to undergo CD19+ testing.
Within 4 months of the screening visit, use of either a) systemic corticosteroids at an average dose of 40 milligrams (mg) prednisone equivalent or higher for more than 14 days or b) oral budesonide delayed release capsules.
The participant has received a live or live-attenuated vaccine within 4 weeks before signing the ICF or has any live or live-attenuated vaccine planned during the clinical trial.
Participation in any other investigational drug trial (including vaccine trial) with receipt of at least 1 dose of investigational drug, or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.
The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
The participant has had any of the following types of infections within the specified timeframes where applicable:
1. Active bacterial, viral, or fungal infection (except for the common cold and onychomycosis), or any other serious infection within 2 weeks of signing the ICF. Any anti-infective course for infection must be completed at least 2 weeks before Visit 1.
2. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) infection within 4 weeks of signing the ICF.
3. Opportunistic infection or treatment for an opportunistic infection less than or equal to (≤)12 weeks before signing the ICF.
4. Active tuberculosis (TB), any history of prior active TB, or any signs or symptoms of active TB infection (including but not limited to chronic fever, chronic productive cough, night sweats, weight loss, or malnutrition) as judged by the investigator.
5. For participants in European Union (EU) member states, positive or 2 indeterminant QuantiFERON results, unless there is documentation of prior complete treatment for latent TB, or participant has initiated prophylaxis based on local guidelines and in consultation with a pulmonology or infectious disease specialist prior to the first administration of IMP.
In the opinion of the investigator, the participant is currently experiencing any medical condition that might interfere with participation in the trial (for example, significant ocular, cardiovascular, pulmonary, hematologic, gastrointestinal, endocrinologic, hepatic, renal, neurologic, malignancy, infectious disease, immunodeficiency, or alcohol and drug abuse), that poses an added risk for the participant or could confound the assessment of trial results.
In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment.
The participant has a history of major surgery within 3 months before screening (or longer, at the discretion of the investigator); or, either has a planned tonsillectomy or underwent a tonsillectomy within 6 months before screening.
Note: Major surgery typically requires at least 1 night in the hospital.
History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical carcinoma-in-situ.
The participant has a history of a severe allergic or anaphylactic reaction to recombinant proteins or excipients used in the mezagitamab or placebo formulation.
The participant has (1) been diagnosed with or has suspected chronic obstructive pulmonary disease (COPD) or asthma and (2) has a prebronchodilatory forced expiratory volume in 1 second (FEV1) <50% of predicted normal at screening.
The participant is capable of breastfeeding but does not agree to forego breastfeeding from first dose of investigational medicinal product (IMP) through 30 days after the last dose of IMP.
The participant is an individual with potential for pregnancy but does not agree to use at least 1 form of highly effective contraception and 1 barrier method of contraception (preferably male condom) when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.
The participant is a sexually active, non-sterilized individual who produces sperm but does not agree to use a barrier method (preferably male condom) combined with at least 1 form of highly effective contraception for any partner(s) with potential for pregnancy when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.
In the investigator's opinion, the participant (and the participant's legally acceptable representative, if applicable per local regulations or determination) is unwilling and/or unable to understand and fully comply with clinical trial procedures and requirements (including digital tools and applications).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mezagitamab Participants will receive mezagitamab injections, subcutaneously (SC), for approximately 22 weeks in each 52-week period.	Drug: Mezagitamab Mezagitamab injections administered SC. Other Names: TAK-079
Placebo Comparator: Placebo Participants will receive mezagitamab-matching placebo injections, SC for approximately 22 weeks in each 52-week period.	Drug: Placebo Mezagitamab-matching placebo injections administered SC.
Experimental: Open-label Mezagitamab Participants will receive mezagitamab injections, SC for approximately 22 weeks in each 52-week period.	Drug: Mezagitamab Mezagitamab injections administered SC. Other Names: TAK-079

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Proteinuria at Week 36 Time Frame: From Baseline to Week 36	Proteinuria will be assessed by urine protein to creatinine ratio (UPCR) calculated from a 24-hour urine collection.	From Baseline to Week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 and 104, Respectively Time Frame: From Baseline to Weeks 52 and 104		From Baseline to Weeks 52 and 104
Time from Baseline to the First Occurrence of Any of the Pre-specified Kidney Failure Composite Assessment Criteria Time Frame: From Baseline to Week 104	The pre-specified assessment criteria will include: sustained decline in eGFR of ≥30% from baseline over at least 4 weeks; sustained eGFR <15 mL/min/1.73 m^2 over at least 4 weeks; initiation of maintenance dialysis defined as dialysis performed for at least 4 weeks; receipt of kidney transplant; or death from kidney failure. Time from baseline to first occurrence of any of the above assessment criteria would be reported.	From Baseline to Week 104
The Rate of Change in eGFR From Baseline at Week 104 Time Frame: From Baseline to Week 104	The rate of change in eGFR from baseline is measured as eGFR total slope.	From Baseline to Week 104
Time From Baseline to the First Occurrence of Sustained Decline in eGFR of ≥30 Percent (%) From Baseline Over at Least 4 Weeks Time Frame: From Baseline to Week 104		From Baseline to Week 104
Change from Baseline in Proteinuria Levels at Weeks 52 and 104 Time Frame: From Baseline to Weeks 52 and 104	Proteinuria will be assessed by UPCR calculated from a 24-hour urine collection.	From Baseline to Weeks 52 and 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Estimated)

September 7, 2028

Study Completion (Estimated)

January 14, 2030

Study Registration Dates

First Submitted

April 30, 2025

First Submitted That Met QC Criteria

April 30, 2025

First Posted (Actual)

May 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

TAK-079-3001
2025-520825-19-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
ICF
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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A Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia

Immune Thrombocytopenic Purpura (ITP)

United States, Japan, Australia, China, Spain, Italy, United Kingdom, Bulgaria, Hong Kong, Croatia, South Korea, Turkey (Türkiye), France, Netherlands, Poland, Greece
Takeda

Completed

A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy

Glomerulonephritis | Kidney Disease

Taiwan, Australia, Hungary, Spain, United Kingdom, China, United States, Japan, Singapore, South Korea, Italy
Takeda

Terminated

A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)

Relapsed and/or Refractory Multiple Myeloma (RRMM)

United States, Canada
Millennium Pharmaceuticals, Inc.

Completed

A Study to Investigate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of TAK-079 Administered Subcutaneously as a Single Agent in Participants With Relapsed/Refractory (r/r) Multiple Myeloma (MM)

Multiple Myeloma | Relapsed/Refractory

United States
Takeda

Completed

A Study to Evaluate Subcutaneous TAK-079 Added to Standard of Care Regimens in Participants With Newly Diagnosed Multiple Myeloma (NDMM)

Multiple Myeloma

United States

A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy

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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Mezagitamab

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