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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest Baptist Health; Wake Forest University Health Sciences
• Treatments: Alemtuzumab; Antilymphocyte Serum; Pancreatin; Pancrelipase

Criteria

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.

Inclusion Criteria:

• 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 Criteria:

• 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