Conditions: Graft Rejection
Keywords: Everolimus heart transplant heart disease transplantation heart IVUS assessment at 12 months rate of graft loss acute rejection episodes survival
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 721
Healthy volunteers: no

Brief summary:
This trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.

Detailed description:

Arms:
arm 1: Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL. arm 2: Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.

Randomization of new patients in this arm was prematurely stopped as of 27 March 2008 due to high mortality rate, as per Data Monitoring Committee. arm 3: Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.

Interventions: intervention 1: everolimus intervention 2: mycophenolate mofetil intervention 3: cyclosporine intervention 4: corticosteroids
Intervention descriptions: intervention 1: Everolimus supplied as 0.75 mg tablets. Everolimus was also supplied in 0.25 mg and 0.5 mg tablets for dose adjustments. intervention 2: Mycophenolate mofetil supplied as 500 mg tablets. intervention 3: Cyclosporine reduced dose in the everolimus arms (approximately half of the standard dose) and standard dose in the mycophenolate mofetil arm. intervention 4: Corticosteroids standard dose.

Protocol document: