Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation

PHASE4CompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

February 28, 2005

Primary Completion Date

November 28, 2011

Study Completion Date

November 28, 2011

Conditions
Graft Rejection
Interventions
DRUG

Alemtuzumab

30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.

DRUG

Anti-Thymocyte Globulin

"1.5 mg/kg per dose through a central line intraoperatively and on POD# 2 and 4, then continue on alternate days until a therapeutic tacrolimus(or cyclosporine) level is achieved, or until the SCr \< 3-4 mg/dL.~Give first dose over 6 hours, subsequent doses over 4 hours.~Premedication to be given with the first 3 doses:~Tylenol 650mg PO/PR Benadryl 25-50mg PO/IV Daily scheduled corticosteroid dose or other corticosteroid as deemed appropriate.~Hold infusion if temperature \> 100.5ºF; Adjust dose for low WBC or Plt count Peripheral Thymoglobulin administration: Prepare dose in 500cc NS; Add heparin 1,000 units and hydrocortisone 20mg to the bag; Infuse over a minimum of 6 hours"

Trial Locations (1)

27157

Wake Forest University Baptist Medical Center, Winston-Salem

All Listed Sponsors
lead

Wake Forest University Health Sciences

OTHER

NCT00331162 - Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation | Biotech Hunter | Biotech Hunter