A Study to Evaluate the Effect of Thymoglobulin and Reduced Doses of Steroids to Prevent Renal Transplant Rejection
Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
Participant gender:
Summary
This study involves the use of a drug called Thymoglobulin, which is approved in the US to
treat kidney transplant rejection and in Canada to treat and to prevent kidney transplant
rejection.
This study will evaluate the effect of Thymoglobulin and reduced doses of steroids to prevent
renal transplant rejection and will provide a basis for future evaluations of Thymoglobulin
as an immunosuppressive agent to help prevent renal transplant rejection.
Subjects meeting all inclusion and exclusion criteria are eligible to participate in this
study. In addition to standard treatment, study participants will receive either
Thymoglobulin with rapid discontinuation of steroids or steroids per hospital standards for
at least the first 90 days after transplant. The treatment assignment is random and is not
chosen by the subject or their physician.
Subjects will be monitored during treatment with Thymoglobulin and during the transplant
hospitalization. Additional subject monitoring occurs at Months 1, 3, 6 and 12 following the
transplant.
Approximately 150 study subjects from 15-20 transplant centers in the United States will be
enrolled.