What is the Purpose of this Study?
The goal of this study is to evaluate the safety and effectiveness of an experimental drug called efgartigimod and how it affects kidney rejection in kidney transplant patients diagnosed with antibody-mediated rejection (AMR). AMR develops when the body recognizes the transplanted kidney as foreign and produces proteins (antibodies) that target the cells of the donor kidney, resulting in a decline in the transplanted kidney’s function. The study will evaluate whether efgartigimod can protect the transplanted kidney and possibly help the kidney to survive longer. Researchers also aim to learn more about the effect of efgartigimod on the body, how it is absorbed and removed from the body, and the immune system’s response to the drug. Efgartigimod is similar to antibodies naturally present in the human body and has been approved for other conditions, but its use in this study is investigational.
Eligibility
- * The participant is within the ages of 18 and 80 years old
- * The participant had a kidney transplant (living or deceased donor) at least 6 months before the study
- * The participant has received a diagnosis of active or chronic active antibody-mediated rejection (AMR) with detectable donor-specific antibodies at time of the study
- * A participant may be allowed into the study if they receive the following medications:
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Efgartigimod in Kidney Transplant Recipients With Antibody-Mediated Rejection