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.

Renal Transplantation Clinical Trial

Official title:

A Prospective Multicenter Open-label Randomized Study to Assess Efficacy and Safety of Everolimus in Combination With Cyclosporine Microemulsion Versus Everolimus Without Calcineurine Inhibitor in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS), in Adult Renal Transplant Patients in Maintenance.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425308
• Other study ID #: CRAD001AFR06
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2007
• Last updated: March 23, 2011
• Start date: October 2006

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: May 2009
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• Everolimus + Cyclosporine

• Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

• Steroids

Locations

Country	Name	City	State
France	Novartis Investigative Site	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From Baseline to Month 12	No
Primary	Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. (Completed Patients)	Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)	From Baseline to Month 12	No
Secondary	Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12		From Baseline to Month 3, 6, and 12	No
Secondary	Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.		Month 6 and 12	No
Secondary	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	No
Secondary	Safety Assessed by Adverse Events and Serious Adverse Events		12 months	No
Secondary	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	From Baseline to Month 3, 6, and 12	No
Secondary	Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12	Change in proteinuria (g/24h) from baseline to M12	From Baseline to Month 3, 6, and 12	No
Secondary	Change in Renal Function Assessed by Microalbuminuria Month 3, Month 6 and Month 12		From Baseline to Month 3, 6, and 12	No
Secondary	Assessing Cardiovascular Risk Factors Based on Fasting Glucose.	Blood chemistry - fasting glycemia (mmol/L)	From Baseline to Month 1, 3, 6, 9, and 12	No
Secondary	Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.	Blood chemistry - total cholesterol (mmol/L)	From Baseline to Month 1, 3, 6, 9, and 12	No
Secondary	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	No
Secondary	Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.		From Baseline to Month 1, 3, 6, 9, and 12	No
Secondary	Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).	Blood chemistry - C-reactive Protein (CRP) (mg/L)	From Baseline to Month 3, 6, and 12	No