Status:
COMPLETED
Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Heart Transplantation
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
In this study two immunosuppressive regimens (everolimus in combination with cyclosporine microemulsion and mycophenolate mofetil with cyclosporine microemulsion) with reduced dose cyclosporine microe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00170859
Start Date
August 1 2004
End Date
December 1 2006
Last Update
November 18 2016
Active Locations (1)
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1
Novartis Investigational Site
Various Cities, Germany