A 12 month, multicenter, randomized, parallel, open-label study, to evaluate renal function and efficacy of Certican® (everolimus) with Simulect® (basiliximab) and cyclosporine discontinuation at 3 month post-transplant vs minimization, in de novo kidney transplant recipients

INTERVENTION:

Trade Name: Certican® Product Name: Certican® Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed

INN:

EVEROLIMUS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.50‐ Trade Name: Certican® Product Name: Certican® Product Code: RAD001 Pharmaceutical Form: Tablet INN or Proposed

INN:

EVEROLIMUS Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.75‐

CONDITION:

Renal Transplant ; MedDRA version: M15 Classification code 10023438

PRIMARY OUTCOME:

Main Objective: The primary objective is to compare renal function in the two treatment groups at month 12 post‐transplant, as measured by calculated GFR (Nankivell), serum creatinine and calculated creatinine clearance (Cockroft‐ Gault).; Intra‐group change in GFR , as determined by Nankivell’s formula, and the GFR’s slope in the period between visits 6 and 12 months will also be determined.; Primary end point(s): The GFR value is calculated using the Nankivell formula. This is the end point in witch sample size is based. Secondary Objective: The secondary objectives of this study are:; • To evaluate the incidence of biopsy‐proven acute rejection (BPAR) episodes, graft loss, death or loss to follow‐up after 12 months in both groups.; • To evaluate the incidence of graft loss, death, BPAR episodes, antibody treated acute rejection episodes, clinically confirmed acute rejection episodes, clinically confirmed chronic rejection episodes and biopsy‐proven chronic allograft nephropathy after 12 months in both groups.; • To evaluate the safety of Certican® in combination with Simulect® and steroids, with either Neoral® discontinuation at 3 months post‐transplant, or Neoral® minimization.;

INCLUSION CRITERIA:

Each patient must meet all of the following

INCLUSION CRITERIA:

1. Male or female patients between 18 and 65 years of age 2. Male or female patients who are recipients of a first renal transplant from a primary cadaveric or non‐HLA identical living related donor . 3. The renal cold ischemic time (CIT) must be < 36 hours 4. The age of the donor must be < 65 years 5. Females of childbearing potential must have a negative pregnancy test at baseline and are required to practice an approved method of birth control for the duration of the study and for a period of three months following discontinuation of study medication. 6. Patients who have given written informed consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range