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

Conditions

• Antibody-Mediated Rejection (AMR)

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Mezagitamab — DRUG
  Mezagitamab subcutaneous (SC) injection.
• Placebo — DRUG
  Mezagitamab-matching placebo SC injection.

Study Details

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.

Key Dates

First listed

May 29, 2026

Start date

Sep 1, 2026

Status verified

Sep 2026

Primary completion

Jan 15, 2029

Completion

Jan 15, 2029

Study Design

Enrollment

36 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• Experimental: Arm B: Mezagitamab
  Participants will receive mezagitamab up to Week 48, followed by an observation period up to Week 70.
• Active Comparator: Arm C: Placebo
  Participants will receive placebo up to Week 48, followed by an observation period up to Week 70.

Primary Outcome Measure

Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to Week 70 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (14)

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