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FREEDOM-1 - 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.
What is the Condition Being Studied?
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

Age Group
Adults

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

Study Details

Full Title
A randomized, controlled, multi-center, safety and efficacy study of FCR001 cell-based therapy relative to a tacrolimus and mycophenolate-based regimen in de novo living donor renal transplant recipients, and safety in FCR001 donors (the FREEDOM-1 study)
Principal Investigator
Kidney/Pancreas Transplant Surgeon
Protocol Number
IRB: PRO00103135
NCT: NCT03995901
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698