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

NCT07613359 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: TAK-079-20022026-526239-20-00jRCT2071260091
• Study Type: interventional
• Target: 36
• Locations: 5 countries
• Sites: 35

Brief 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.

Conditions

Antibody-Mediated Rejection (AMR)

Keywords

Drug Therapy; TAK-079

Outcome Measures

Primary Outcomes (6)

• Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

  An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational medicinal product (IMP).

  Up to Week 70

• Arms A, B, and C: Number of Participants With Related TEAEs

  A related AE is an AE that is considered related to the IMP. Related TEAEs are defined as related AEs with start dates at the time of or following the first exposure to IMP.

  Up to Week 70

• Arms A, B, and C: Number of Participants With Serious Adverse Events (SAEs)

  An SAE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.

  Up to Week 70

• Arms A, B, and C: Number of Participants With AEs of Special Interest

  AEs of special interest are AEs that are considered specific to the IMP.

  Up to Week 70

• Arms A, B, and C: Number of Participants With AE Leading to Treatment Discontinuation

  Up to Week 70

• Arms A, B, and C: Number of Participants With Clinically Significant Abnormal Laboratory Test Results and Vital Signs

  Up to Week 70

Secondary Outcomes (16)

• Arms A, B, and C: Percentage of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Weeks 24 and 48

  Weeks 24 and 48

• Arms A, B, and C: Microvascular Inflammation (MVI) Score in Biopsy Samples at Weeks 24 and 48

  Weeks 24 and 48

• Arms A, B, and C: Percentage of Participants Who Achieve a MVI Score of 0 at Weeks 24 and 48

  Weeks 24 and 48

• Arms A, B, and C: Change From Baseline in MVI score at Weeks 24 and 48

  Baseline, Weeks 24 and 48

• Arms A, B, and C: Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Weeks 24, 48 and 70

  Baseline, Weeks 24, 48 and 70

Study Arms (3)

Arm A: Mezagitamab + Placebo

EXPERIMENTAL

Participants will receive mezagitamab up to Week 24, followed by placebo up to Week 48, followed by an observation period up to Week 70.

Drug: Mezagitamab; Drug: Placebo

Arm B: Mezagitamab

EXPERIMENTAL

Participants will receive mezagitamab up to Week 48, followed by an observation period up to Week 70.

Drug: Mezagitamab

Arm C: Placebo

ACTIVE COMPARATOR

Participants will receive placebo up to Week 48, followed by an observation period up to Week 70.

Drug: Placebo

Interventions

Mezagitamab DRUG

Mezagitamab subcutaneous (SC) injection.

Also known as: TAK-079

Arm A: Mezagitamab + Placebo; Arm B: Mezagitamab

Placebo DRUG

Mezagitamab-matching placebo SC injection.

Arm A: Mezagitamab + Placebo; Arm C: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant aged 18 to 80 years.
• The participant must have a biopsy-confirmed diagnosis of active or chronic active late AMR (defined as greater than \[\>\] 6 month after kidney transplant) without concurrent definitive TCMR (Grade 1a and above) as defined by the 2022 Banff classification.
• Biopsy within 30 days prior to screening, or performed during screening period within protocol-defined window.
• If the participant has received treatment for rejection, then the repeat biopsy and donor specific antibody (DSA) testing must have been performed at least 6 weeks after stopping the treatment.
• The participant with either human leukocyte antigen (HLA) class I and/or II DSA.
• eGFR \> 30 milliliters per minute per 1.73 square meters (mL/min/1.73m\^2).

You may not qualify if:

• The participant has blood type A, B, AB, or O (ABO) incompatible transplant.
• The participant has a history of multiple organ transplants, including en bloc and dual kidney transplants.
• Participant likely to require renal replacement therapy within the subsequent 30 days.
• Participants who have received an anti-cluster of differentiation 38 (CD38) therapy in the last 1 year or have past history of failing to achieve AMR resolution despite treatment with an anti-CD38 therapy.
• The participant has received any previous treatment with other immunosuppressant or immunomodulatory therapy:
• a) Within 6 months of signing the informed consent form (ICF) as listed below:
• Complement system inhibitors (such as, eculizumab).
• Proteasome inhibitors (such as, bortezomib).
• Interleukin-6 (IL-6)/IL-6R antibody (such as, tocilizumab).
• Anti-cluster of differentiation 20 (CD20) antibody (such as, rituximab). b) Within 6 weeks of signing the ICF as listed below:
• Intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) or plasmapheresis
• The participant has active infection with hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
• Participant with serious infection within 2 weeks or with opportunistic infection within 2 months prior to signing ICF. Participant with active or untreated tuberculosis, or those with high suspicion of tuberculosis are also excluded.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (35)

UCLA University of California Los Angeles

Los Angeles, California, 90024, United States

Location

Kaiser Permanente-San Francisco Medical Center - Kidney Transplant Clinic

San Francisco, California, 94118, United States

Location

University of Miami Hospital and Clinics

Miami, Florida, 33136, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cooperman Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

NYU Langone Health - Transplant Associates

New York, New York, 10016, United States

Location

Weill Cornell Medicine - Nephrology and Kidney Transplantation Medicine

New York, New York, 10021, United States

Location

Cleveland Clinic - Cleveland

Cleveland, Ohio, 44195, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Intermountain Healthcare

Murray, Utah, 84107, United States

Location

Virginia Commonwealth University (VCU) - Medical Center - Hume-Lee Transplant Center (HLTC)

Richmond, Virginia, 23298, United States

Location

Froedtert and The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

The First Affiliated Hospital of Sun Yat-sen University

Guangdong, Guangdong, 510080, China

Location

The Second Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530007, China

Location

Tongji Hospital Affiliated to Tongji Medicine University

Wuhan, Hubei, 430075, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250013, China

Location

West China Hospital Sichuan University

Chengdu, Sichuan, 610000, China

Location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

CHU Bordeaux, CHU Pellegrin

Bordeaux, 33076, France

Location

Hopital Henri Mondor

Créteil, 94000, France

Location

Hopital Edouard Herriot (HEH)

Lyon, 69003, France

Location

CHU de Toulouse - Hopital Rangueil

Toulouse, France

Location

Kliniken Universitatsklinikum Bochum GmbH

Bochum, North Rhine-Westphalia, 44892, Germany

Location

Universitaetsklinikum Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Ludwig-Maximilians-Universitaet Muenchen (LMU) Klinikum der Universitaet Muenchen

München, 81377, Germany

Location

Universitaetsklinikum Muenster

Münster, Germany

Location

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, 466-8650, Japan

Location

Japanese Red Cross Kumamoto Hospital

Kumamoto, Kumamoto, 861-8520, Japan

Location

Yochomachi Clinic

Shinjuku-ku, Tokyo, 162-0055, Japan

Location

Niigata University Medical and Dental Hospital

Niigata, 951-8520, Japan

Location

Osaka Metropolitan University Hospital

Osaka, 545-8585, Japan

Location

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Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 15, 2029
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

JP (5); US (14); DE (4); CN (8); FR (4)