An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.
The objectives of the study are:To compare the renal function of a quadruple immunosuppressive regimen (including basiliximab in combination with an optimized cyclosporine dose during the first weeks post-transplantation, mycophenolate mofetil and corticosteroids) versus a standard triple therapy regimen (including cyclosporine standard dose, mycophenolate mofetil and corticosteroids)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.|
- Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation
- Frequency and severity of rejection episodes before 6 and 12 months post-transplantation
- Frequency of death, graft loss or retransplantation before 6 and 12 months post-transplantation
- Adverse events
- Duration of initial hospitalization and number or hospital re-admissions.
|Study Start Date:||May 2002|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|