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.
- Conditions
- Renal Transplantation
- Interventions
- Registration Number
- NCT00425308
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) Steroids 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 Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) 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 Everolimus + Cyclosporine 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 Everolimus + Cyclosporine Steroids 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
- Primary Outcome Measures
Name Time Method Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. From Baseline to Month 12 Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial From Baseline to Month 12 Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
- Secondary Outcome Measures
Name Time Method Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol. From Baseline to Month 3, 6, and 12 Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. From Baseline to Month 1, 3, 6, 9, and 12 Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). From Baseline to Month 3, 6, and 12 Blood chemistry - C-reactive Protein (CRP) (mg/L)
Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12 From Baseline to Month 3, 6, and 12 Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. 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. Month 12 Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12 From Baseline to Month 3, 6, and 12 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 From Baseline to Month 3, 6, and 12 Change in proteinuria (g/24h) from baseline to M12
Assessing Cardiovascular Risk Factors Based on Fasting Glucose. From Baseline to Month 1, 3, 6, 9, and 12 Blood chemistry - fasting glycemia (mmol/L)
Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. From Baseline to Month 1, 3, 6, 9, and 12 Blood chemistry - total cholesterol (mmol/L)
Trial Locations
- Locations (1)
Novartis Investigative Site
🇫🇷Paris, France