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A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Sponsor: Takeda
Summary
Antibody-mediated rejection (AMR) is a major cause of worsening kidney function after a kidney transplant (kidney allograft dysfunction) and can lead to kidney failure. AMR happens when the kidney recipient's immune system makes antibodies that attack the donor kidney. Antibodies are proteins made by the immune system to recognize foreign cells. Over time, this attack can damage kidney tissue and cause the transplant to fail. Because AMR can be serious, there is a need for treatments that are safe, work well, and are supported by good evidence. The main aim of this study is to find out how safe mezagitamab is and how well adults with AMR tolerate it compared with placebo. A placebo looks like medicine but has no active ingredients. The study will also look at whether mezagitamab helps to control inflammation in the transplanted kidney and helps keep kidney function stable, compared with placebo. Participants will be placed by chance in 1 of the 3 treatment groups in equal numbers. Two groups will receive mezagitamab in two different doses. One group will receive placebo. This means that out of every 3 participants, 2 will receive mezagitamab and 1 will receive placebo. During the study, participants will visit their study clinic several times.
Official title: A Double-Blind, Placebo-Controlled, Multicenter, Randomized, Phase 2 Trial to Evaluate the Safety and Efficacy of Mezagitamab (TAK-079) in Kidney Transplant Recipients With Late Antibody-Mediated Rejection (AMR)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
36
Start Date
2026-10-15
Completion Date
2029-01-15
Last Updated
2026-10-01
Healthy Volunteers
No
Conditions
Interventions
Mezagitamab
Mezagitamab subcutaneous (SC) injection.
Placebo
Mezagitamab-matching placebo SC injection.
Locations (35)
UCLA University of California Los Angeles
Los Angeles, California, United States
Kaiser Permanente-San Francisco Medical Center - Kidney Transplant Clinic
San Francisco, California, United States
University of Miami Hospital and Clinics
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
University of Maryland
Baltimore, Maryland, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooperman Barnabas Medical Center
Livingston, New Jersey, United States
NYU Langone Health - Transplant Associates
New York, New York, United States
Weill Cornell Medicine - Nephrology and Kidney Transplantation Medicine
New York, New York, United States
Cleveland Clinic - Cleveland
Cleveland, Ohio, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Intermountain Healthcare
Murray, Utah, United States
Virginia Commonwealth University (VCU) - Medical Center - Hume-Lee Transplant Center (HLTC)
Richmond, Virginia, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Sun Yat-sen University
Guangdong, Guangdong, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Tongji Hospital Affiliated to Tongji Medicine University
Wuhan, Hubei, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
CHU Bordeaux, CHU Pellegrin
Bordeaux, France
Hopital Henri Mondor
Créteil, France
Hopital Edouard Herriot (HEH)
Lyon, France
CHU de Toulouse - Hopital Rangueil
Toulouse, France
Kliniken Universitatsklinikum Bochum GmbH
Bochum, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, Germany
Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum der Universitaet Muenchen
München, Germany
Universitaetsklinikum Muenster
Münster, Germany
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Nagoya, Aichi-ken, Japan
Japanese Red Cross Kumamoto Hospital
Kumamoto, Kumamoto, Japan
Yochomachi Clinic
Shinjuku-ku, Tokyo, Japan
Niigata University Medical and Dental Hospital
Niigata, Japan
Osaka Metropolitan University Hospital
Osaka, Japan