Efgartigimod in Kidney Transplant Recipients With AMR - SHAMROCK - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called efgartigimod (the study drug) is a safe and effective option for people experiencing kidney rejection. We want to know if it can decrease antibody-mediated rejection following a transplant by removing the antibodies that target and damage the cells of the donated kidney.
Antibody-Mediated Rejection Following Kidney Transplant
Who Can Participate in the Study?
Adults ages 18-80 who:
- Received a kidney transplant at least 6 months ago
- Are diagnosed with biopsy-confirmed antibody-mediated rejection
- Are using an immunosuppressing medication for maintenance following their transplant
For more information, contact the study team at lynnette.moats@duke.edu.
What is Involved?
If you choose to join this study, you will get a random assignment (fair, equal chance) to 1 of 3 groups. Depending on your group assignment, you may:
- Take the study drug for 48 weeks; OR
- Take a placebo (inactive substance with no drug in it) for 48 weeks; OR
- Take a combination of the study drug (first 24 weeks) and a placebo (second 24 weeks)
The study will last for about 20 months, and it involves at least 20 study visits. The study visits will include the following procedures: study drug injections, physical exams, blood draws, biopsies, chest x-ray, electrocardiograms, and genetic tests.
Study Details
