Conditions: Renal Transplantation
Keywords: Renal transplantation, everolimus, immunosuppressants, CNI-free
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 300
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess whether a calcineurin inhibitor (CNI)-free regimen with enteric-coated mycophenolate sodium (EC-MPS) and everolimus is as safe and well-tolerated as the standard regimen containing enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion, but results in better renal function.

Detailed description:

Arms:
arm 1: Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant. arm 2: Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.

Interventions: intervention 1: Everolimus intervention 2: Cyclosporine intervention 3: Enteric-coated mycophenolate sodium intervention 4: Corticosteroids
Intervention descriptions: intervention 1: Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL. intervention 2: Tablets orally twice a day to maintain protocol specific target blood levels intervention 3: Enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. intervention 4: Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.

Protocol document: