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NOT YET RECRUITING
NCT07613359
PHASE2

A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant

Sponsor: Takeda

View on ClinicalTrials.gov

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

Interventions

DRUG

Mezagitamab

Mezagitamab subcutaneous (SC) injection.

DRUG

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