Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06963827
PHASE3

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

Sponsor: Takeda

View on ClinicalTrials.gov

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

DRUG

Mezagitamab

Mezagitamab injections administered SC.

DRUG

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