RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Mezagitamab for 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.

Official registry: https://clinicaltrials.gov/study/NCT07613359 · Takeda · enrollment listed as 36

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Mezagitamab, or Placebo. The registry lists allocation as randomized. 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.

They plan to enroll about 36 people at 35 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: Mezagitamab, Placebo

Primary outcome (registry wording): Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
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)

Who the registry excludes

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:
Complement system inhibitors (such as, eculizumab)
Proteasome inhibitors (such as, bortezomib)

Public study contact (from the registry)

Takeda Contact

+1-877-825-3327

medinfoUS@takeda.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

35 listed

UCLA University of California Los Angeles — Los Angeles, California (not_yet_recruiting)
Kaiser Permanente-San Francisco Medical Center - Kidney Transplant Clinic — San Francisco, California (not_yet_recruiting)
University of Miami Hospital and Clinics — Miami, Florida (not_yet_recruiting)
Tampa General Hospital — Tampa, Florida (not_yet_recruiting)
University of Maryland — Baltimore, Maryland (recruiting)
Washington University School of Medicine — St Louis, Missouri (not_yet_recruiting)
Cooperman Barnabas Medical Center — Livingston, New Jersey (recruiting)
NYU Langone Health - Transplant Associates — New York, New York (not_yet_recruiting)
Weill Cornell Medicine - Nephrology and Kidney Transplantation Medicine — New York, New York (not_yet_recruiting)
Cleveland Clinic - Cleveland — Cleveland, Ohio (not_yet_recruiting)
University of Texas Southwestern Medical Center — Dallas, Texas (not_yet_recruiting)
Intermountain Healthcare — Murray, Utah (not_yet_recruiting)

+ 21 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07613359 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07613359?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07613359?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary