Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

• Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. [ Time Frame: From Baseline to Month 12 ] [ Designated as safety issue: No ]
  Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
• Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. (Completed Patients) [ Time Frame: From Baseline to Month 12 ] [ Designated as safety issue: No ]
  Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)

• Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 [ Time Frame: From Baseline to Month 3, 6, and 12 ] [ Designated as safety issue: No ]
• Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. [ Time Frame: Month 6 and 12 ] [ Designated as safety issue: No ]
• Number of Participants With Treatment Failures Assessed by Biopsy-proven Acute Rejection (BPAR), Graft Loss/Re-transplantation, Death or Lost to Follow-up at Month 12. [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
• Safety Assessed by Adverse Events and Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
• Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 [ Time Frame: From Baseline to Month 3, 6, and 12 ] [ Designated as safety issue: No ]
  Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12
• Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12 [ Time Frame: From Baseline to Month 3, 6, and 12 ] [ Designated as safety issue: No ]
  Change in proteinuria (g/24h) from baseline to M12
• Change in Renal Function Assessed by Microalbuminuria Month 3, Month 6 and Month 12 [ Time Frame: From Baseline to Month 3, 6, and 12 ] [ Designated as safety issue: No ]
• Assessing Cardiovascular Risk Factors Based on Fasting Glucose. [ Time Frame: From Baseline to Month 1, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  Blood chemistry - fasting glycemia (mmol/L)
• Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. [ Time Frame: From Baseline to Month 1, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  Blood chemistry - total cholesterol (mmol/L)
• Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. [ Time Frame: From Baseline to Month 3, 6, and 12 ] [ Designated as safety issue: No ]
• Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. [ Time Frame: From Baseline to Month 1, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
• Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). [ Time Frame: From Baseline to Month 3, 6, and 12 ] [ Designated as safety issue: No ]
  Blood chemistry - C-reactive Protein (CRP) (mg/L)

• Change in renal function assessed by serum creatinine, creatinine clearance, proteinuria, microalbuminuria, ratio proteinuria/serum creatinine at Month 3, Month 6 and Month12
• Incidence and severity of biopsy-proven acute rejection (BPAR) at Month 6 and Month 12.
• Incidence of treatment failure assessed by BPAR, graft loss/re-transplantation, death or lost to follow-up at Month 6 and Month 12.
• Assessing cardiovascular risk factors based on fasting glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and CRP.
• Safety assessed by adverse events and serious adverse events

Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

• Drug: Everolimus + Cyclosporine
  Other Names:

  • Cyclosporine Microemulsion
  • Neoral
• Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
  Other Name: Myfortic
• Drug: Steroids

• Active Comparator: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
  Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
  Interventions:

  • Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
  • Drug: Steroids
• Active Comparator: Everolimus + Cyclosporine
  Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
  Interventions:

  • Drug: Everolimus + Cyclosporine
  • Drug: Steroids

Inclusion criteria:

• Patients who participated in and completed study CRAD001A2420

Exclusion criteria:

• Premature study or study treatment discontinuation in CRAD001A2420 study.
• Acute rejection within the 3 months prior to inclusion

Other protocol-defined inclusion/exclusion criteria may apply