Felzartamab in Kidney Txp with AMR - TRANSCEND (Post-Transplant Kidney Rejection) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called felzartamab (the study drug) is a safe and effective option for people who have had a kidney transplant and are experiencing antibody-mediated rejection (AMR). We want to know if this drug provides any helpful benefit.
Late Antibody-Mediated Rejection (AMR) of Kidney Transplant
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with active or chronic AMR of a donor kidney
- Are up-to-date on all recommended vaccines
- Are on stable immunosupression therapy consistent with clinical guidelines
For more information, contact the study team at jerry.turner@duke.edu.
What is Involved?
There are two parts to this study, Part A and Part B. Whether you participate in Part A or Part B will depend on when you join the study. We will let you know which part of the study is active before you make a decision to join.
If you choose to join this study during Part A, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- Group 1: If you are in this group, you will get the study drug.
- Group 2: If you are in this group, you will get a placebo (inactive substance with no drug in it).
During Part B of the study, all participants will get the study drug. The study drug or placebo is administered by intravenous (IV) infusion into a vein in the arm.
During the course of the study, all participants will have physical exams, blood draws, biopsies, and surveys to fill out.
Study Details
