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Clinical trialNCT06963827RecruitingPhase 3Interventional

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

SponsorTakedaEnrollment347Kidney Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

176 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

    Alejandra Smuclir Quevedo
    Recruiting
  • Framingham Centro Medico

    Buenos Aires, La Plata, Argentina

    Martin Mamberti
    Recruiting
  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, Argentina

    Hernan Trimarchi Jurado
    Recruiting
  • Clinica Privada Velez Sarsfield

    Córdoba, Argentina

    Rafael Alberto Maldonado
    Recruiting
Australia
  • South Western Sydney Local Health District - University of New South Wales - Liverpool Hospital

    Liverpool, New South Wales, Australia

    Beata Zahorowska
    Recruiting
  • Core Research Group

    Milton, Queensland, Australia

    David Colquhoun
    Recruiting
  • Eastern Health

    Box Hill, Victoria, Australia

    Darren Lee
    Recruiting
  • Monash Heath - Monash University - Monash Medical Centre

    Clayton, Victoria, Australia

    Jessica Ryan
    Recruiting
  • Western Health Sunshine Hospital

    St Albans, Victoria, Australia

    Eugenia Pedagogos
    Recruiting
Austria
  • Johannes Kepler Universitat Linz, Universitatsklinik Fur Innere 2

    Linz, Austria

    Alexander Moschen
    Recruiting
  • Medizinische Universitat Wien (medical University of Vienna - Austria)

    Vienna, Austria

    Rainer Oberbauer
    Recruiting
Canada
  • Sheldon M. Chumir Health Centre

    Calgary, Alberta, Canada

    Louis Girard
    Recruiting
  • London Health Sciences Centre

    London, Ontario, Canada

    Matthew Weir
    Recruiting
  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, Canada

    Michelle Hladunewich
    Recruiting
China
  • Peking University First Hospital

    Beijing, Beijing Municipality, China

    Jicheng Lv
    Recruiting
  • Beijing Tsinghua Changgung Hospital

    Changping, Beijing Municipality, China

    Yuehong Li
    Recruiting
  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, China

    Bo Xu
    Recruiting
  • Guangdong General Hospital

    Guangzhou, Guangdong, China

    Zhiming Ye
    Recruiting
  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, China

    Zu-Ying Xiong
    Recruiting
  • the Third Xiangya Hospital of Central South University Yuelu District

    Changsha, Hunan, China

    Hao Zhang
    Recruiting
  • the First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia, China

    Zengyan Li
    Recruiting
  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, China

    Liu Bicheng
    Recruiting
  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, China

    Xinzhong Huang
    Recruiting
  • Wuxi People'S Hospital

    Wuxi, Jiangsu, China

    Liang Wang
    Recruiting
  • the First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

    Yan Yan
    Recruiting
  • Shandong University - Qilu Hospital

    Jinan, Shandong, China

    Xiang-Dong Yang
    Recruiting
  • Ruijin Hospital of Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, China

    Jingyuan Xie
    Recruiting
  • Shanghai Jiao Tong University School of Medicine (sjtusm) - Renji Hospital - Eastern Branch

    Shanghai, Shanghai Municipality, China

    Leyi Gu
    Recruiting
  • Sichuan Academy of Medical Sciences & Sichuan Provincial People'S Hospital

    Chengdu, Sichuan, China

    Guisen Li
    Recruiting
  • West China Hospital Sichuan University

    Chengdu, Sichuan, China

    Ping Fu
    Recruiting
  • the Second People'S Hospital of Yibin

    Yibin, Sichuan, China

    Deqiong Xie
    Recruiting
  • the Second Affiliated Hospital, Zhejiang University, School of Medicine

    Hangzhou, Zhejiang, China

    Kunling Ma
    Recruiting
  • the First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang, China

    Xueyan Bian
    Recruiting
Czechia
  • Nemocnice Agel Novy Jicin A.S

    Nový Jičín, Moravskoslezsk Kraj, Czechia

    Vaclava Honova
    Recruiting
  • First Faculty of Medicine Charles University

    Prague, Czechia

    Vladimir Tesar
    Recruiting
France
  • Hospital Henri Mondor

    Créteil, Paris, France

    Vincent Audard
    Recruiting
  • Chu Bordeaux, Chu Pellegrin

    Bordeaux, France

    Claire Rigothier
    Recruiting
  • Chu Limoges Service de Nephrology

    Limoges, France

    Fatouma Toure
    Recruiting
  • Centre Hospitalier Universitaire de Montpellier (chu Montpellier) - Hopital Lapeyronie

    Montpellier, France

    Moglie Le Quintrec
    Recruiting
  • Chu de Nantes

    Nantes, France

    Simon Ville
    Recruiting
136 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

MezagitamabPlacebo
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
15 Jul 2025
Primary completion
7 Sept 2028
Completion
14 Jan 2030
Last update posted
14 Aug 2026
Registered enrollment
347
Registry id
NCT06963827

Cross-registrations

EU-CTR / CTIS (EudraCT)2025-520825-19-00

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.