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

Condition(s) studied

Investigational drug(s) / intervention(s)

Mezagitamab: Mezagitamab subcutaneous (SC) injection.

Placebo: Mezagitamab-matching placebo SC injection.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Arms A, B, and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — Up to Week 70
  An adverse event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the trial intervention. TEAEs are defined as AEs with start dates at the time of or following the first exposure to investigational medicinal product (IMP).
• Arms A, B, and C: Number of Participants With Related TEAEs — Up to Week 70
  A related AE is an AE that is considered related to the IMP. Related TEAEs are defined as related AEs with start dates at the time of or following the first exposure to IMP.
• Arms A, B, and C: Number of Participants With Serious Adverse Events (SAEs) — Up to Week 70
  An SAE is any untoward medical occurrence that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
• Arms A, B, and C: Number of Participants With AEs of Special Interest — Up to Week 70
  AEs of special interest are AEs that are considered specific to the IMP.
• Arms A, B, and C: Number of Participants With AE Leading to Treatment Discontinuation — Up to Week 70
• Arms A, B, and C: Number of Participants With Clinically Significant Abnormal Laboratory Test Results and Vital Signs — Up to Week 70

Trial sites (35)

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