An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.
Phase 4
Completed
- Conditions
- Liver Transplantation
- Registration Number
- NCT00343226
- Lead Sponsor
- Novartis
- Brief Summary
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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Renal function (i.e. glomerular filtration rate) at 12 months post-transplantation
- Secondary Outcome Measures
Name Time Method 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.