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Efficacy and Safety of Everolimus With Enteric-Coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion-free Regimen Compared to Standard Therapy in de Novo Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00154310
First received: September 8, 2005
Last updated: October 21, 2013
Last verified: October 2013
Results First Received: January 11, 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
Drug: Cyclosporine
Drug: Enteric-coated mycophenolate sodium
Drug: Corticosteroids

  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 study was an open-label, randomized, parallel-group, multi-center study with two treatment groups, cyclosporine continuation and cyclosporine withdrawal starting from Month 4.5 post-transplant. Study started in June 2005 and ended in September 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Everolimus + Mycophenolate Sodium Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
Cyclosporine + Mycophenolate Sodium Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.

Participant Flow:   Overall Study
    Everolimus + Mycophenolate Sodium     Cyclosporine + Mycophenolate Sodium  
STARTED     155 [1]   145  
COMPLETED     118     117  
NOT COMPLETED     37     28  
Adverse Event                 19                 9  
Lack of Efficacy                 5                 4  
Protocol Violation                 4                 2  
Withdrawal by Subject                 9                 3  
Lost to Follow-up                 0                 8  
Administrative problems                 0                 1  
Death                 0                 1  
[1] "Started" indicates enrolled participants. Randomized participants for two arms are 154 and 146.



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Renal Function (Nankivell Formula) at Month 12 Post Transplantation.   [ Time Frame: at Month 12 post transplantation ]

2.  Secondary:   Number of Participants With Occurrence of Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death   [ Time Frame: Up to Month 12 ]

3.  Secondary:   Number of Participants With Occurrence of Treatment Failures   [ Time Frame: up to or at Month 12 ]

4.  Secondary:   Changes in Cardiovascular Risk From Month 4.5 to Final Assessment at Month 12   [ Time Frame: Month 4.5 and Month 12 ]

5.  Secondary:   Number of Participants Who Experienced an Adverse Event or Serious Adverse Event   [ Time Frame: Aes from end of core study period (month 12) to end of follow-up period (month 60) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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