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.
Age range
18 Years – 80 Years
Sex
ALL
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The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Up to Week 70
Arms A, B, and C: Number of Participants With Related TEAEs
Timeframe: Up to Week 70
Arms A, B, and C: Number of Participants With Serious Adverse Events (SAEs)
Timeframe: Up to Week 70
Arms A, B, and C: Number of Participants With AEs of Special Interest
Timeframe: Up to Week 70
Arms A, B, and C: Number of Participants With AE Leading to Treatment Discontinuation
Timeframe: Up to Week 70
Arms A, B, and C: Number of Participants With Clinically Significant Abnormal Laboratory Test Results and Vital Signs
Timeframe: Up to Week 70