An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.
A multicenter clinical study comparing event-free survival at 6 months after transplant between Thymoglobulin-treated and Simulect-treated adult kidney transplant patients. Patients received Thymoglobulin or Simulect from Day 0 through Day 4. Day 0 was considered the day of the transplant procedure.
Subjects meeting all inclusion and exclusion criteria were eligible to participate in this study. The treatment assignment was random and not chosen by the subject or their physician.
Subjects were monitored during treatment with Thymoglobulin and during the transplant hospitalization. Additional subject monitoring occurred up to 12 months after transplant.
278 study subjects were enrolled at 28 transplant centers in the United States and Europe.
|Cadaveric Donor Renal Transplantation Acute Renal Allograft Rejection Induction Therapy||Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)] Drug: Simulect (basliximab)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||An Open-Label Prospective, Randomized, Multicenter Phase II Comparative Trial of Thymoglobulin® Versus Simulect® for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients|
- Freedom from acute rejection, kidney transplant loss, delayed kidney transplant function and death at 6 months after transplant. [ Time Frame: 6 months ]
- 12-mo. safety & efficacy assessments including side effects and overall kidney transplant function. [ Time Frame: 12 months ]
|Study Start Date:||May 2000|
|Study Completion Date:||June 2005|
|Primary Completion Date:||April 2003 (Final data collection date for primary outcome measure)|
Active Comparator: 1 Control
Drug: Simulect (basliximab)
20 mg per day on 2 days
Thymoglobulin (anti-thymocyte globulin (rabbit))
Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
1.5 mg/kg per day, for a maximum of 5 doses
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235300
Show 28 Study Locations
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|