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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Novartis Investigative Site
Paris, France
Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Time frame: From Baseline to Month 12
Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial
Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Time frame: From Baseline to Month 12
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
Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.
Time frame: Month 6 and 12
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
Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12
Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12
Time frame: From Baseline to Month 3, 6, and 12
Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12
Change in proteinuria (g/24h) from baseline to M12
Time frame: From Baseline to Month 3, 6, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Glucose.
Blood chemistry - fasting glycemia (mmol/L)
Time frame: From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.
Blood chemistry - total cholesterol (mmol/L)
Time frame: From Baseline to Month 1, 3, 6, 9, and 12
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
Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.
Time frame: From Baseline to Month 1, 3, 6, 9, and 12
Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).
Blood chemistry - C-reactive Protein (CRP) (mg/L)
Time frame: From Baseline to Month 3, 6, and 12
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