FREEDOM-1 (Kidney Transplant) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to learn about the benefits the study drug (FCR001) may have compared to standard medicine in kidney transplants.
Kidney Transplant
Who Can Participate in the Study?
- Adults 18-60
- Never had a kidney transplant
You cannot participate in this study if you are:
- Pregnant or nursing
- Have HIV
- Have Hepatitis B or C
What is Involved?
If you choose to join this study you will:
- Be randomized (like flipping a coin) to Group 1 or group 2:
-- Group 1 will:
- Receive the study drug (FCR001) which is a a stem cell-based medicine
- Apheresis (a way to filter blood and get stem cells)
- Start conditioning medicine 4 days before transplant surgery
- Complete about 20 visits over 5 years
- Get kidney biopsies
--Group 2 will:
- Get standard care
- Complete about 20 visits over 5 years
- Get kidney biopsies