Mezagitamab for adults with late antibody-mediated rejection after kidney transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 randomized, placebo-controlled study evaluating mezagitamab in adults with active or chronic active late antibody-mediated rejection after kidney transplantation. Participants are assigned by chance to one of three treatment groups in equal numbers to assess safety, tolerability, and impact on kidney inflammation and function. The trial uses biopsy-confirmed criteria and specific exclusion rules to enroll suitable patients and monitor response over time. Primary goals are to determine safety and tolerability, with secondary aims including effects on inflammation and kidney function stability. The study is sponsored by Takeda and involves three U.S. sites: UCLA, Kaiser San Francisco, and University of Miami.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Maryland
  Baltimore, Maryland, United States Recruiting
• Cooperman Barnabas Medical Center
  Livingston, New Jersey, United States Recruiting
• Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
  Nagoya, Aichi-ken, Japan Recruiting
• Japanese Red Cross Kumamoto Hospital
  Kumamoto, Kumamoto, Japan Recruiting
• UCLA University of California Los Angeles
  Los Angeles, California, United States Not yet recruiting
• Kaiser Permanente-San Francisco Medical Center - Kidney Transplant Clinic
  San Francisco, California, United States Not yet recruiting

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Follow-up mezagitamab treatment for adults with chronic primary immune thrombocytopenia

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• Mezagitamab treatment for adults with chronic immune thrombocytopenia

  This study is testing if a new treatment called mezagitamab can help adults with chronic immune thrombocytopenia keep their platelet counts stable compared to a placebo.

  Recruiting at 69 sites Phase 3 Takeda · Hot Springs, Arkansas and 123 other locations · NCT06722235

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.