Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
Phase 4
Completed
- Conditions
- Heart Transplantation
- Registration Number
- NCT00170859
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microemulsion are compared in maintenance heart transplant recipients with impaired renal function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Recipients of primary heart transplant
- Reduced renal function (serum creatinine > 1.7 ng/mL over 2 months or more) at 6 months or more after heart transplantation
- Patients with current immunosuppressive therapy consisting of cyclosporine microemulsion and mycophenolate mofetil
Exclusion Criteria
- Patients who are recipients of multiple organ transplants
- Patients who have previously received an organ transplant
- Patients with serum creatinine > 3.5 mg/dl
Other protocol-defined exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Novartis Investigational Site
🇩🇪Various Cities, Germany