Conditions: Chronic Renal Failure
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief summary:
The primary objective of this trial is to show non-inferiority of a CNI-free regimen with respect to the renal function at Month 9 post Tx assessed by glomerular filtration rate - Nankivell method - as compared to the standard CNI-based regimen in de novo renal transplant patients.

Detailed description:

Arms:
arm 1: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 \[Month 3 (+1 week) after transplantation\], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively. arm 2: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 \[Month 3 (+1 week) after transplantation\], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.

Interventions: intervention 1: Everolimus intervention 2: Tacrolimus (FK506) intervention 3: Basiliximab intervention 4: Enteric Coated Mycophenolate Sodium (EC-MPS) intervention 5: Corticosteroids
Intervention descriptions: intervention 1: One tablet containing 0.25, 0.5mg or 0.75 mg. Initially 2 mg/day. Afterwards based on blood level (target 6-10 ng/mL) intervention 2: Capsules 0.5 mg, 1 mg. Dosing according to blood level. intervention 3: One vial containing 20 mg lyophilisate. 2 x 20 mg \[day 0 (2 hrs prior to Tx) and day 4 post Tx\] to be applied as 10 sec. bolus injection, i.v. intervention 4: One tablet containing 180 mg or 360 mg. 1440 mg/day (2x720 mg). If tolerated, dose reduction due to side effectis were possible (min. dose at BL@: 720 mg/day) intervention 5: Used according to Israeli standards. A minimum dose of 5mg \[prednisone, or equivalent, was used throughout the study period.

Protocol document: