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
  Purpose

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).


Condition Intervention Phase
Renal Transplantation
Drug: Everolimus + Cyclosporine
Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
Drug: Steroids
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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)


Enrollment: 30
Study Start Date: October 2006
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
Other Name: Myfortic
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
Drug: Everolimus + Cyclosporine
Other Names:
  • Cyclosporine Microemulsion
  • Neoral
Drug: Steroids

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00425308

Locations
France
Novartis Investigative Site
Paris, France
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00425308     History of Changes
Other Study ID Numbers: CRAD001AFR06
Study First Received: January 19, 2007
Results First Received: January 6, 2011
Last Updated: March 23, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Novartis:
Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Mycophenolic Acid
Mycophenolate mofetil
Everolimus
Sirolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 21, 2014