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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.

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00425308
First received: January 19, 2007
Last updated: March 23, 2011
Last verified: March 2011

January 19, 2007
March 23, 2011
October 2006
May 2009   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
  • Change in Glomerular Filtration Rate Estimated by Iohexol Plasma Clearance 12 Months After Randomization Between the 2 Groups of Patients. (Completed Patients) [ Time Frame: From Baseline to Month 12 ] [ Designated as safety issue: No ]
    Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)
Change in glomerular filtration rate estimated by iohexol plasma clearance 12 months after randomization between the 2 groups of patients.
Complete list of historical versions of study NCT00425308 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. [ Time Frame: Month 6 and 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Safety Assessed by Adverse Events and Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 [ Time Frame: From Baseline to Month 3, 6, and 12 ] [ Designated as safety issue: No ]
    Change in proteinuria (g/24h) from baseline to M12
  • Change in Renal Function Assessed by Microalbuminuria Month 3, Month 6 and Month 12 [ Time Frame: From Baseline to Month 3, 6, and 12 ] [ Designated as safety issue: No ]
  • Assessing Cardiovascular Risk Factors Based on Fasting Glucose. [ Time Frame: From Baseline to Month 1, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
    Blood chemistry - fasting glycemia (mmol/L)
  • Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. [ Time Frame: From Baseline to Month 1, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
    Blood chemistry - total cholesterol (mmol/L)
  • 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 ] [ Designated as safety issue: No ]
  • Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. [ Time Frame: From Baseline to Month 1, 3, 6, 9, and 12 ] [ Designated as safety issue: No ]
  • Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). [ Time Frame: From Baseline to Month 3, 6, and 12 ] [ Designated as safety issue: No ]
    Blood chemistry - C-reactive Protein (CRP) (mg/L)
  • Change in renal function assessed by serum creatinine, creatinine clearance, proteinuria, microalbuminuria, ratio proteinuria/serum creatinine at Month 3, Month 6 and Month12
  • Incidence and severity of biopsy-proven acute rejection (BPAR) at Month 6 and Month 12.
  • Incidence of treatment failure assessed by BPAR, graft loss/re-transplantation, death or lost to follow-up at Month 6 and Month 12.
  • Assessing cardiovascular risk factors based on fasting glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides and CRP.
  • Safety assessed by adverse events and serious adverse events
Not Provided
Not Provided
 
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.
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.

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Transplantation
  • Drug: Everolimus + Cyclosporine
    Other Names:
    • Cyclosporine Microemulsion
    • Neoral
  • Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
    Other Name: Myfortic
  • Drug: Steroids
  • Active Comparator: 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
    Interventions:
    • Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
    • Drug: Steroids
  • Active Comparator: 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
    Interventions:
    • Drug: Everolimus + Cyclosporine
    • Drug: Steroids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
May 2009   (final data collection date for primary outcome measure)

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

Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00425308
CRAD001AFR06
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Novartis
Novartis
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP