A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Public ClinicalTrials.gov record NCT07613359. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT07613359
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 36 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2026
- Primary completion
- Jan 14, 2029
- Completion
- Jan 14, 2029
- Last update posted
- Sep 8, 2026
2026 – 2029
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA University of California Los Angeles | Los Angeles | California | 90024 | — |
| Kaiser Permanente-San Francisco Medical Center - Kidney Transplant Clinic | San Francisco | California | 94118 | — |
| University of Miami Hospital and Clinics | Miami | Florida | 33136 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| University of Maryland | Baltimore | Maryland | 21201 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Cooperman Barnabas Medical Center | Livingston | New Jersey | 07039 | — |
| NYU Langone Health - Transplant Associates | New York | New York | 10016 | — |
| Weill Cornell Medicine - Nephrology and Kidney Transplantation Medicine | New York | New York | 10021 | — |
| Cleveland Clinic - Cleveland | Cleveland | Ohio | 44195 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Intermountain Healthcare | Murray | Utah | 84107 | — |
| Virginia Commonwealth University (VCU) - Medical Center - Hume-Lee Transplant Center (HLTC) | Richmond | Virginia | 23298 | — |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07613359, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 8, 2026 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07613359 live on ClinicalTrials.gov.