This study is testing a new medication called felzartamab for people who have received a kidney transplant and developed a type of rejection called late antibody-mediated rejection (AMR).
About this study
Kidney transplants can save lives for people with kidney failure. But even after a successful transplant, the body's immune system can sometimes attack the new kidney, in a process called antibody-mediated rejection (AMR). In this study, researchers will learn more about how a study drug called felzartamab affects people with AMR. The study compares felzartamab to a placebo to find out if it is safe and helps protect the transplanted kidney. Participants will receive either the study drug or placebo for part of the study, followed by felzartamab for the remainder. The study involves clinic visits, blood and urine tests, kidney biopsies, and health checks over about one year.
Anticipated enrolment close date: November 2026
Who can take part
You may be eligible to participate if:
- you are an adult that has had a kidney transplant
- you are diagnosed with late antibody-mediated rejection (AMR)
- it has been at least 6 months since the transplant
You may not be able to participate if:
- you are pregnant or breastfeeding
Other eligibility criteria may apply.
What's involved for you
- regular clinic visits (approximately 15-22 visits over one year)
- screening tests (blood, urine, electrocardiogram, and kidney biopsy)
- intravenous (IV) infusions of the study drug or placebo
- kidney biopsies at 6 and 12 month marks
- questionnaires about symptoms and quality of life
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by an Australian registered and certified HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2025). This statement protects the interests of people who agree to participate in human research studies.