40
Participants
Start Date
December 31, 2007
Primary Completion Date
July 1, 2017
Study Completion Date
July 1, 2017
Belatacept
Belatacept will be given within 24 hours of transplantation via a peripheral intravenous catheter at a dose of 10mg/kg (actual body weight) infused over 30 mins. The dose will be repeated on study days 4 (post op day 3) and 8 (post op day 7), then every 2 weeks for 5 additional doses. Thereafter, belatacept will be given once every 4 weeks (+/- 3 days) at 10mg/kg through 6 months then at 5mg/kg indefinitely.
Sirolimus
Sirolimus will be started on postoperative day 1 at a dose of 2 mg per day orally. Doses will be adjusted to maintain 24-hour trough levels of 8-10ng/ml until the drug is weaned. Toxicity attributable to sirolimus (e.g., mouth ulcers, arthralgias) will prompt dose reduction to address clinical concerns in this regard. If sirolimus trough levels need to be reduced below 4ng/ml to control drug side effects, the patient will be considered intolerant to the drug and will be changed to other medications.
Alemtuzumab
All participants will receive a single dose of 30 mgs of alemtuzumab on the day of transplantation.
Emory University Hospital, Atlanta
The Emory Clinic, Atlanta
Collaborators (2)
Bristol-Myers Squibb
INDUSTRY
Duke University
OTHER
Allan D Kirk, MD, PhD
OTHER