MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard steroids, as measured by the hepatic function tests (ALT/AST) after 12 months treatment.
De Novo Kidney Transplant
Drug: Enteric-coated Mycophenolate sodium (EC-MPS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Twelve-month, Randomized, Multicenter, Open-label, Exploratory Study to Investigate the Clinical Outcomes of an Immunosuppressive Regimen of Basiliximab, Cyclosporine Microemulsion (CsA-ME) and Enteric-coated Mycophenolate Sodium (EC-MPS) Free of Steroids Compared With a Regimen of EC-MPS With Standard Steroids in de Novo Kidney Recipients Who Are Hepatitis C Positive|
- Hepatic function tests (ALT/AST) after 12 months treatment.
- Acumulative incidence of biopsy proven acute rejection after 3 and 12 months.
- Graft loss, biopsy-proven acute rejection after 3 and 12 months treatment.
- Glomerular filtration rate and by proteinuria after 12 months treatment.
- Graft survival after 12 months.
- Incidence of AEs and SAEs after 3 and 12 months.
- Blood pressure, lipids and glucose profiles after 3 and 12 months.
- Percentage of patients free of steroids at 12 months between the two investigational groups.
- Viral load (HCV RNA) between both groups at 12 months.
- Bone density at 12 months in both groups.
|Study Start Date:||April 2004|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|