Conditions: Kidney Transplantation
Keywords: Everolimus mycophenolate CNI-free kidney transplantation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 802
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare renal function of immunosuppressive regimens with different relevance of the calcineurin inhibitor (CNI) cyclosporine: standard dose CNI, low dose CNI, CNI free in de novo kidney transplant patients after 12 months of therapy.

Detailed description:

Arms:
arm 1: Myfortic, Sandimmun Optoral and corticosteroids arm 2: CNI free regimen: comprising the following steps for switching treatment:

Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids arm 3: CNI low regimen: comprising the following steps for switching treatment:

Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids

Interventions: intervention 1: Everolimus intervention 2: Myfortic intervention 3: Sandimmun Optoral intervention 4: Simulect®
Intervention descriptions: intervention 1: Tablet containing 0.5 mg or 0.75 mg. Dosing schedule: Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen intervention 2: 1 tablet containing 180 mg or 360 mg

Dosing schedule:

Initially 1.5 mg/day, then based on blood level (5-10 ng/mL in CNI free, 3-8 ng/mL in CNI low regimen) According to blood level 1440 mg/day (2 x 720 mg), if tolerated. Dose reduction possible in case of side effects (min. dose at BL2 (Month 3): 720 mg/day) intervention 3: 1 capsule containing 10, 25, 50, or 100mg. Dosing: According to blood level intervention 4: Lyophilisate in vials with ampoules of sterile water for injection (5 ml). Dosing: 1 vial containing 20 mg lyophilisate. Dosing schedule: 2 x 20 mg to be applied as 10 sec. bolus injection, i.v. on Day 0 (2 h before transplant) and on Day 4

Protocol document: