Use of Belatacept During Post Depletional Repopulation to Facilitate Tolerance in Renal Allograft Recipients
This study will be a single-center, open-label,proof of concept study in non-HLA-identical
living and deceased donor renal transplants. The initial 20 subjects were randomized to
either receive/not to receive a single donor bone marrow infusion in addition to the
investigational combination of alemtuzumab, belatacept, and sirolimus. Since the bone marrow
infusion has been eliminated in the second group of 20 subjects, no randomization will be
required. All recipients in the second group of 20 subjects will receive the same
investigational combination of alemtuzumab, belatacept, and sirolimus.
At the time of transplant, participants will receive a 3-hour IV infusion of 30 mg. of
alemtuzumab. Participants will receive a combination of sirolimus and belatacept for at
least 1 year. At that time, eligible participants will consent to and begin oral
immunosuppressive withdrawal or continue therapy through study close. Sirolimus will first
be weaned by halving the dose and/or increasing the dosing interval over at least a 2-6
month period. After sirolimus is discontinued, participants will remain on monthly IV
belatacept monotherapy indefinitely.
Follow-up will continue for at least five years. If subjects are successfully weaned from
oral immunosuppression during their participation in this trial, no other alternative
therapy will be warranted. Since belatacept is now FDA approved, subjects will be eligible
to continue this therapy after their study participation has ended.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint will be the number of patients successfully withdrawn from oral immunosuppression for one year after their last dose of an immunosuppressive drug.
Allan D. Kirk, M.D.
United States: Food and Drug Administration
|The Emory Clinic||Atlanta, Georgia 30322|
|Emory University Hospital||Atlanta, Georgia 30322|