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.

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00425308
• Date of registration: 19/01/2007
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: 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.
• Scientific 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.
• Date of first enrolment: October 2006
• Target sample size: 30
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00425308
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Novartis
• Affiliation: Novartis

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Transplantation

Intervention(s)

Drug: Steroids

Drug: Everolimus + Cyclosporine

Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)

Primary Outcome(s)

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]

Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial [Time Frame: From Baseline to Month 12]

Secondary Outcome(s)

Assessing Cardiovascular Risk Factors Based on Fasting Glucose. [Time Frame: From Baseline to Month 1, 3, 6, 9, and 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]

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]

Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. [Time Frame: From Baseline to Month 1, 3, 6, 9, and 12]

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]

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]

Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. [Time Frame: Month 6 and 12]

Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). [Time Frame: From Baseline to Month 3, 6, 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]

Secondary ID(s)

CRAD001AFR06

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/04/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00425308