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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.

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ClinicalTrials.gov Identifier: NCT00425308
Recruitment Status : Completed
First Posted : January 22, 2007
Results First Posted : April 19, 2011
Last Update Posted : March 30, 2017
Sponsor:
Information provided by:
Novartis

Study Description
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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).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2006
Actual Primary Completion Date : May 2009

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)

  2. 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 ]
    Primary efficacy endpoint: between treatment analysis of change in iohexol plasmatic clearance (mL/min) from baseline to Month 12 (M12)


Secondary Outcome Measures :
  1. 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 ]
  2. Number of Participants With Biopsy-proven Acute Rejection (BPAR) at Month 6 and Month 12. [ Time Frame: Month 6 and 12 ]
  3. 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 ]
  4. 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 ]
    Change in creatinine clearance, Nankivell formula (mL/min/1.73m²) from baseline to M12

  5. 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 ]
    Change in proteinuria (g/24h) from baseline to M12

  6. Assessing Cardiovascular Risk Factors Based on Fasting Glucose. [ Time Frame: From Baseline to Month 1, 3, 6, 9, and 12 ]
    Blood chemistry - fasting glycemia (mmol/L)

  7. Assessing Cardiovascular Risk Factors Based on Fasting Total Cholesterol. [ Time Frame: From Baseline to Month 1, 3, 6, 9, and 12 ]
    Blood chemistry - total cholesterol (mmol/L)

  8. 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 ]
  9. Assessing Cardiovascular Risk Factors Based on Fasting Triglycerides. [ Time Frame: From Baseline to Month 1, 3, 6, 9, and 12 ]
  10. Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP). [ Time Frame: From Baseline to Month 3, 6, and 12 ]
    Blood chemistry - C-reactive Protein (CRP) (mg/L)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00425308


Locations
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France
Novartis Investigative Site
Paris, France
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Novartis
More Information
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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00425308    
Other Study ID Numbers: CRAD001AFR06
First Posted: January 22, 2007    Key Record Dates
Results First Posted: April 19, 2011
Last Update Posted: March 30, 2017
Last Verified: February 2017
Keywords provided by Novartis:
Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy
Additional relevant MeSH terms:
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Cyclosporine
Mycophenolic Acid
Everolimus
Cyclosporins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
 Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors
Antineoplastic Agents
Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents