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

• 2 other identifiers: TAK-079-20022026-526239-20-00
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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

Related Links

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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): September 1, 2026
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 15, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-06

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.