Study of Alemtuzumab Versus Anti-thymocyte Globulin to Help Prevent Rejection in Kidney and Pancreas Transplantation
Status:
Completed
Trial end date:
2011-11-28
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 4
Details
Lead Sponsor:
Wake Forest Baptist Health Wake Forest University Health Sciences