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

StatusNot Yet Recruiting
PhasePhase 2
SponsorTakeda
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date pushed from Sep 1, 2026 to Oct 15, 2026 Eligibility criteria expanded, about 19 words · Secondary endpoints: details revised at 2 of 16 entries · Site details revised at 1 of 35 sites Show 3 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 2 of 16 entries
    • Site details revised at 1 of 35 sites
  2. Trial sites expanded: 0 → 35 locationsv3
  3. Eligibility criteria expanded, about 28 wordsv2 See this version in full on ClinicalTrials.gov ↗
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Takeda
221 trials monitored
See 15 trials at risk
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.
Trial Details
NCT Number NCT07613359
Lead Sponsor Takeda
Conditions Antibody-Mediated Rejection (AMR)
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov