NCT00170859
Completed
Phase 4
A One-year Multicenter, Randomized, Open-label Study of the Safety and Efficacy of Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
ConditionsHeart Transplantation
DrugsEverolimus
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Heart Transplantation
- Sponsor
- Novartis Pharmaceuticals
- Locations
- 1
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.Renal TransplantationNCT00425308Novartis Pharmaceuticals30
Completed
Phase 3
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant RecipientsLung TransplantationNCT01404325Novartis Pharmaceuticals130
Completed
Phase 3
Efficacy and Safety of Everolimus in Recipients of Heart Transplants to Prevent Acute and Chronic RejectionGraft RejectionNCT00300274Novartis Pharmaceuticals721
Completed
Phase 3
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor KidneysKIDNEY TRANSPLANTATIONNCT00321113Astellas Pharma Inc142
Completed
Phase 3
mTor-inhibitor (EVERolimus) Based Immunosuppressive Strategies for CNI Minimisation in OLD for Old Renal TransplantationRenal TransplantNCT01028092University Hospital, Brest327