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
Phase 3
Terminated
- Conditions
- De Novo Kidney Transplant
- Registration Number
- NCT00284921
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hepatic function tests (ALT/AST) after 12 months treatment.
- Secondary Outcome Measures
Name Time Method 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.