Belatacept Post Depletional Repopulation to Facilitate Tolerance

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

July 1, 2017

Study Completion Date

July 1, 2017

Conditions
Organ Transplantation
Interventions
DRUG

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.

DRUG

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.

DRUG

Alemtuzumab

All participants will receive a single dose of 30 mgs of alemtuzumab on the day of transplantation.

Trial Locations (2)

30322

Emory University Hospital, Atlanta

The Emory Clinic, Atlanta

Sponsors
All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Duke University

OTHER

lead

Allan D Kirk, MD, PhD

OTHER

NCT00565773 - Belatacept Post Depletional Repopulation to Facilitate Tolerance | Biotech Hunter | Biotech Hunter