Study of Safety and Efficacy of a Basiliximab, Mycophenolate Mofetil, Cyclosporine Microemulsion and Prednisone Combination Treatment Regimen in Pediatric Renal Allograft Recipients
The aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, MMF, and prednisone combined compared to cyclosporine microemulsion, MMF and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft recipients.
Pediatric Kidney Transplantation
Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)
Drug: MMF, cyclosporine, steroids
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||A Randomized, Placebo-controlled, Double-blind, Multicenter Study Investigating Basiliximab in Combination With MMF, Cyclosporine Microemulsion and Prednisone in the Prevention of Acute Rejection in Pediatric Renal Allograft Recipients|
- Time to first BPAR episode or treatment failure [ Time Frame: 6 months ] [ Designated as safety issue: No ]Treatment failure is defined as: graft loss, death, or initiation of anti-rejection therapy without prior biopsy-proven rejection (in case of medical contraindication for a biopsy).
|Study Start Date:||May 2001|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Patients will be on a regimen of Basiliximab, MMF, cyclosporine and steroids
|Drug: basiliximab, MMF(mycophenolate mofetil), cyclosporine, prednisone (or equivalent)|
Active Comparator: Basiliximab-free
Patients will be on a regimen of MMF, cyclosporine and steroids.
|Drug: MMF, cyclosporine, steroids|