Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation
The purpose of this research study is to compare the effects of the two most commonly used anti-T cell induction agents(alemtuzumab and rabbit anti-thymocyte globulin) to prevent rejection in kidney and pancreas transplant patients. Alemtuzumab is Food and Drug Administration (FDA) approved for treating a certain type of cancer (leukemia), and Thymoglobulin® (rabbit anti-thymocyte globulin) is approved for anti-rejection treatment, but neither drug is FDA approved for administration at the time of transplantation to help prevent rejection. Even so, many transplant centers use these medications at the time of transplantation and believe that their use helps to decrease the risk of developing rejection following kidney and pancreas transplantation. Which drug might be better is not known. Subjects will receive either alemtuzumab (one administration) or rabbit anti-thymocyte (3 to 7 doses) at and within the first week of transplantation. Subjects will be assigned to either the alemtuzumab or rabbit anti-thymocyte globulin groups by chance. The two groups will be compared to see if there are meaningful differences for survival, organ function, side effects, and quality of life. The follow-up care after transplant for subjects in the study is the same as that for patients who are not in the study, except that a quality of life questionnaire (estimated to take 10 minutes to complete) will be completed at the time of transplant and through year 2 during selected scheduled clinic visits. A retrospective chart review will occur at 3-5 years post-transplant to follow incidence of chronic rejection, patient and graft survival and graft function.
Drug: Anti-Thymocyte Globulin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Alemtuzumab Versus Thymoglobulin Induction Therapy in Kidney and Pancreas Transplantation|
- Patient survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Graft survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Acute Rejection [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Hematologic adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Infectious adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Other adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Cost [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Health status and quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2005|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Active Comparator: 1
30 mg/100ml NS intraoperatively. Start after dexamethasone administration and prior to reperfusion of the allograft. Infuse over a minimum of 2 hours.
Active Comparator: 2
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00331162
|United States, North Carolina|
|Wake Forest University Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Alan C Farney, MD, Ph.D.||Wake Forest Baptist Health|