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

June 2, 2026 updated by: Takeda

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key inclusion criteria:

  1. The participant aged 18 to 80 years.
  2. 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.
  3. Biopsy within 30 days prior to screening, or performed during screening period within protocol-defined window.
  4. 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.
  5. The participant with either human leukocyte antigen (HLA) class I and/or II DSA.
  6. eGFR > 30 milliliters per minute per 1.73 square meters (mL/min/1.73m^2).

Key exclusion criteria:

  1. The participant has blood type A, B, AB, or O (ABO) incompatible transplant.
  2. The participant has a history of multiple organ transplants, including en bloc and dual kidney transplants.
  3. Participant likely to require renal replacement therapy within the subsequent 30 days.
  4. 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.

  5. 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
  6. The participant has active infection with hepatitis B virus, hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
  7. 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.
  8. 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.

Key Note: Other protocol specified inclusion and exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Mezagitamab + Placebo
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
Mezagitamab subcutaneous (SC) injection.
Other Names:
  • TAK-079
Drug: Placebo
Mezagitamab-matching placebo SC injection.
Experimental: Arm B: Mezagitamab
Participants will receive mezagitamab up to Week 48, followed by an observation period up to Week 70.
Drug: Mezagitamab
Mezagitamab subcutaneous (SC) injection.
Other Names:
  • TAK-079
Active Comparator: Arm C: Placebo
Participants will receive placebo up to Week 48, followed by an observation period up to Week 70.
Drug: Placebo
Mezagitamab-matching placebo SC injection.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 70
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
Time Frame: Up to Week 70
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)
Time Frame: Up to Week 70
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
Time Frame: Up to Week 70
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
Time Frame: Up to Week 70
Up to Week 70
Arms A, B, and C: Number of Participants With Clinically Significant Abnormal Laboratory Test Results and Vital Signs
Time Frame: Up to Week 70
Up to Week 70

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Arms A, B, and C: Percentage of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Weeks 24 and 48
Time Frame: Weeks 24 and 48
Achievement of biopsy-proven histological resolution of AMR activity will be assessed by the 2022 Banff classification criteria. The Banff 2022 Classification provides a standardized framework for evaluating kidney transplant biopsies using lesion scoring.
Weeks 24 and 48
Arms A, B, and C: Microvascular Inflammation (MVI) Score in Biopsy Samples at Weeks 24 and 48
Time Frame: Weeks 24 and 48
MVI is an important marker of allograft loss and is defined as the sum of glomerulitis and peritubular capillaritis scores (g+ptc) on kidney histology.
Weeks 24 and 48
Arms A, B, and C: Percentage of Participants Who Achieve a MVI Score of 0 at Weeks 24 and 48
Time Frame: Weeks 24 and 48
Weeks 24 and 48
Arms A, B, and C: Change From Baseline in MVI score at Weeks 24 and 48
Time Frame: Baseline, 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
Time Frame: Baseline, Weeks 24, 48 and 70
eGFR is a measure of kidney function calculated from serum creatinine using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
Baseline, Weeks 24, 48 and 70
Arms A, B, and C: Change From Baseline in Donor-Derived Cell-Free DNA (dd-cfDNA) at Weeks 24, 48 and 70
Time Frame: Baseline, Weeks 24, 48 and 70
dd-cfDNA are DNA fragments released from injured donor cells. It serves as a noninvasive, quantitative method that reflects allograft injury and is associated with AMR activity in kidney transplant recipients.
Baseline, Weeks 24, 48 and 70
Arms A, B, and C: Change From Baseline in Urine Protein Creatinine Ratio (UPCR) at Weeks 24, 48 and 70
Time Frame: Baseline, Weeks 24, 48 and 70
UPCR is a measure of protein excretion calculated from a urine sample, as the ratio of urine protein to creatinine, and used to assess kidney function.
Baseline, Weeks 24, 48 and 70
Arm B: Percentage of Participants With Achievement of Biopsy-Proven Histologic Resolution of AMR Activity at Week 70
Time Frame: Week 70
Week 70
Arm B: MVI Score in Biopsy Samples at Week 70
Time Frame: Week 70
Week 70
Arm B: Percentage of Participants Who Achieve a MVI Score of 0 at Week 70
Time Frame: Week 70
Week 70
Arm B: Change From Baseline in MVI score at Week 70
Time Frame: Week 70
Week 70
Arms A, B, and C: Percentage of Participants With T-Cell Mediated Rejection (TCMR) by Biopsy at Weeks 24 and 48
Time Frame: Weeks 24 and 48
Weeks 24 and 48
Arm B: Percentage of Participants With TCMR by Biopsy at Week 70
Time Frame: Week 70
Week 70
Arms A and B: Serum Concentration of Mezagitamab
Time Frame: Pre-dose and at multiple time points post-dose up to Week 70
Pre-dose and at multiple time points post-dose up to Week 70
Arms A, B and C: Number of Participants With Anti-Drug Antibody
Time Frame: Pre-dose and at multiple time points post-dose up to Week 70
Pre-dose and at multiple time points post-dose up to Week 70
Arms A, B and C: Number of Participants With Neutralizing Antibody
Time Frame: Pre-dose and at multiple time points post-dose up to Week 70
Pre-dose and at multiple time points post-dose up to Week 70

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Takeda

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TAK-079-2002
  • 2026-526239-20-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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