Belatacept Post Depletional Repopulation to Facilitate Tolerance
Status:
Completed
Trial end date:
2017-07-01
Target enrollment:
Participant gender:
Summary
Acute rejection is a common problem after a kidney transplant. Rejection can occur when the
kidney recipient's immune system tries to attack (or reject) the new kidney. Rejection
typically most often develops in the first few months after a transplant.
This single center study will seek to determine if a new combination of anti-rejection
medications, including the recently FDA approved drug called Belatacept, is better than the
current standard anti-rejection drug regimen at preventing rejection. Also to be determined
will be whether the new combination of drugs will allow participants to wean off their oral
anti-rejection medications over time.
This study will test the safety and effectiveness of a new investigational drug combination
using alemtuzumab, belatacept, and sirolimus when given with or without donor bone marrow.
This combination of medicines has not been tested before in humans. Alemtuzumab (Campath) is
approved for use in some types of white blood cell cancers, but is considered investigational
in transplant patients. Belatacept is now FDA approved and is being studied in transplant
patients. Sirolimus (Rapamune) is approved for use in transplant patients, but its use with
belatacept and alemtuzumab is investigational.
In the initial 20 subjects enrolled in the study, half tested whether an infusion of bone
marrow from the kidney donor would improve the effect of these drugs. This bone marrow
infusion was also considered investigational.
Enrollment of 20 additional subjects began in January, 2013. The donor bone marrow infusion
has been eliminated. Enrollment was open to primary living and deceased donor kidney
recipients. Enrollment was closed as of 8/12/2014.