Multi-center, open-label, prospective, randomized, parallel group, long-term study investigating a standard regimen in de novo kidney transplant patients versus a CNI-free regimen and a CNI-low dose regimen

INTERVENTION: Trade Name: Certican Tabletten Product Name: Certican Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus CAS Number: 159351‐69‐6 Current Sponsor code: RAD001 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ Trade Name: Certican Tabletten Product Name: Certican Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus CAS Number: 159351‐69‐6 Current Sponsor code: RAD001 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.75‐ Trade Name: Simulect 20 mg Product Name: Simulect 20 mg Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Basiliximab CAS Number: 179045‐86‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Trade Name: Myfortic 180 mg/ ‐360 mg Filmtabletten Product Name: Myfortic 180 mg/‐ 360 mg Filmtabletten Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Mycophenolate sodium CAS Number: 24280‐93‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 180‐ Trade Name: Myfortic 180 mg/ ‐360 mg Filmtabletten Product Name: Myfortic 180 mg/‐ 360 mg Filmtabletten Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Mycophenolate sodium CAS Number: 24280‐93‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 360‐ Trade Name: Sandimmun Optoral 10 mg, 25 mg, 50 mg, 100 mg Kapseln Product Name: Sandimmun Optoral Pharmaceutical Form: Capsule* INN or Proposed INN: Ciclosporin CAS Number: 59865‐13‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10‐ Trade Name: Sandimmun Optoral 10 mg, 25 mg, 50 mg, 100 mg Kapseln Product Name: Sandimmun Optoral Pharmaceutical Form: Capsule* INN or Proposed INN: Ciclosporin CAS Number: 59865‐13‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25‐ Trade Name: Sandimmun Optoral 10 mg, 25 mg, 50 mg, 100 mg Kapseln Product Name: Sandimmun Optora CONDITION: de novo kidney transplant patients ; MedDRA version: 9.1 Level: LLT Classification code 10023439 Term: Kidney transplant rejection PRIMARY OUTCOME: Main Objective: The primary objective of this trial is to demonstrate superiority of a CNI‐free regimen respect to the renal function at Month 12 post Tx assessed by glomerular filtration rate – Nankivell method – as compared to the standard regimen in de novo kidney transplant patients. Primary end point(s): The primary aim of this study is to demonstrate superior renal function under the CNI‐free regimen as compared to the Standard regimen.; The primary variable for assessment of renal function is the glomerular filtration rate (GFR) at Month 12, as assessed by the Nankivell method. Secondary Objective: • to assess renal function by glomerular filtration rate at Month 12 post Tx of the CNI‐low dose regimen compared to the standard regimen; • to assess renal function by glomerular filtration rate at Month 12 post Tx; • to assess renal function by serum creatinine at month 12 post Tx; • to assess efficacy at Month 6 and 12; • to asses occurrence of treatment failures up to or at Month 12; • to assess evolution of renal function between Month 3 and 12 ; • to assess safety and tolerability at Month 12: ; ‐ AE/SAE ; ‐ incidence of infections (with special emphasis on CMV) ; ‐ tumor incidence ; ‐ cardiovascular risk (changes in Framingham score) ; ‐ occurrence of proteinuria; • to assess efficacy, safety and tolerability at Follow‐up visits at month 18, 24, 36, 48, and 60; INCLUSION CRITERIA: 1. Males or females, aged 18 – 70 years 2. Recipients of de novo cadaveric, living unrelated or living related kidney transplants 3. Females capable of becoming pregnant must have a negative serum pregnancy test within 7 days prior to or at Baseline visit 1, and are required to practice an approved method of birth control for the duration of the study and for a period of 6 weeks following discontinuation of study medication, even where there has been a history of infertility 4. Patients who are willing and able to participate in the study and from whom written informed consent has been obtained 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) yes F.1.3.1 Number of subjects for this age range