Clinical trial NCT00425308: 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients.
timeFrame: From Baseline to Month 12
measure: Change in the Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients Who Completed Trial
timeFrame: From Baseline to Month 12
Secondary outcomes:
measure: Change in Renal Function Assessed by Serum Creatinine at Month 3, Month 6 and Month 12
timeFrame: From Baseline to Month 3, 6, and 12
measure: Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12.
timeFrame: Month 6 and 12
measure: 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.
timeFrame: Month 12
measure: Change in Renal Function Assessed by Creatinine Clearance at Month 3, Month 6 and Month 12
timeFrame: From Baseline to Month 3, 6, and 12
measure: Change in Renal Function Assessed by Proteinuria at Month 3, Month 6 and Month 12
timeFrame: From Baseline to Month 3, 6, and 12
measure: Assessing Cardiovascular Risk Factors Based on Fasting Glucose.
timeFrame: From Baseline to Month 1, 3, 6, 9, and 12
measure: Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol.
timeFrame: From Baseline to Month 1, 3, 6, 9, and 12
measure: Assessing Cardiovascular Risk Factors Based on Fasting High-density Lipoprotein (HDL) Cholesterol, Low-density Lipoprotein (LDL) Cholesterol.
timeFrame: From Baseline to Month 3, 6, and 12
measure: Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides.
timeFrame: From Baseline to Month 1, 3, 6, 9, and 12
measure: Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).
timeFrame: From Baseline to Month 3, 6, and 12
Other outcomes:
Locations:
city: Paris
country: France
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: