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
Results First Received: January 6, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Transplantation
Interventions: Drug: Everolimus + Cyclosporine
Drug: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS)
Drug: Steroids

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This is a prospective, national, multicenter, randomized, open label study, 12 months duration. Ten centers have been included with a study start October 2006 and end date May 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cyclosporine Control Arm: 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
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

Participant Flow:   Overall Study
    Cyclosporine     Enteric-coated Mycophenolate Sodium (EC-MPS)  
STARTED     15     15  
COMPLETED     11     14  
NOT COMPLETED     4     1  
Adverse Event                 2                 1  
Withdrawal by Subject                 1                 0  
Death                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cyclosporine Control Arm: 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
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
Total Total of all reporting groups

Baseline Measures
    Cyclosporine     Enteric-coated Mycophenolate Sodium (EC-MPS)     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: years]
Mean ± Standard Deviation
  62.3  ± 9.46     58.8  ± 7.55     60.6  ± 8.60  
Gender  
[units: participants]
     
Female     4     2     6  
Male     11     13     24  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Secondary:   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 ]

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

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

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

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

10.  Secondary:   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 ]

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

12.  Secondary:   Assessing Cardiovascular Risk Factors Based on Fasting C-reactive Protein (CRP).   [ Time Frame: From Baseline to Month 3, 6, and 12 ]

13.  Secondary:   Safety Assessed by Adverse Events and Serious Adverse Events   [ Time Frame: 12 months ]
Results not yet posted.   Anticipated Posting Date:   11/2010   Safety Issue:   No

14.  Secondary:   Change in Renal Function Assessed by Microalbuminuria Month 3, Month 6 and Month 12   [ Time Frame: From Baseline to Month 3, 6, and 12 ]
Results not yet posted.   Anticipated Posting Date:   12/2010   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


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)