Everolimus Versus Mycophenolate Mofetil in Combination With Reduced Dose Cyclosporine Microemulsion in Maintenance Heart Transplant Recipients

Novartis

Status and phase: Completed; Phase 4

Conditions: Heart Transplantation

Treatments: Drug: Everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00170859

CRAD001ADE01

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)