Status:
COMPLETED
Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Graft Rejection
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 a...
Detailed Description
Anti-Thymocyte Globulin, rabbit (r-ATG, Thymoglobulin®) is a polyclonal antibody against T-lymphocytes that is used for the prevention and treatment of acute allograft rejection. r-ATG induction thera...
Eligibility Criteria
Inclusion
- Enrollment of kidney transplant patients has been completed. The protocol has been amended to enroll 50 additional subjects who will receive either a simultaneous pancreas and kidney transplant, pancreas after kidney transplant, or solitary pancreas transplant.
- Male or female patients who receive a simultaneous pancreas and kidney transplant, pancreas after kidney transplant, or solitary pancreas transplant
- Age 18 to 65
- Females of child bearing potential must have a negative pregnancy test at time of transplant
- Ability to give informed consent
Exclusion
- Inability to give informed consent
- ABO incompatibility
- T-cell or B-cell positive cross match
- Patients with a previous hypersensitivity to alemtuzumab, anti-thymocyte globulin, or any monoclonal or polyclonal antibody preparation
- Current active infection (currently receiving antibiotics, treatment for active infection within 1 week of transplant, or medical judgement)
- Hepatitis B surface antigen positive
- Human immunodeficiency virus positive
- Any malignancy within 2 years except for successfully treated basal or squamous cell carcinoma of skin
- Pregnancy
- Breast feeding women
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 28 2011
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT00331162
Start Date
February 1 2005
End Date
November 28 2011
Last Update
September 6 2018
Active Locations (1)
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1
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157