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Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01150097
First received: April 23, 2010
Last updated: July 17, 2014
Last verified: July 2014
Results First Received: May 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Liver Transplant Recipient
Interventions: Drug: Tacrolimus (reduced tacrolimus)
Drug: Everolimus (reduced tacrolimus)
Drug: Tacrolimus (tacrolimus elimination)
Drug: Everolimus (tacrolimus elimination)
Drug: Tacrolimus (tacrolimus control)
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants in the tacrolimus control group were studied for 12 months (from months 24 to 36 post transplant). Participants in the tacrolimus elimination and everolimus + reduced tacrolimus groups were studied for a minimum of 12 months up to 24 months (from months 24 to 48 months post transplant) depending on the participant's study start.

Reporting Groups
  Description
Everolimus + Reduced Tacrolimus Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
Tacrolimus Elimination Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
Tacrolimus Control Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.

Participant Flow for 2 periods

Period 1:   Months 24 to 36 Post-transplantation
    Everolimus + Reduced Tacrolimus     Tacrolimus Elimination     Tacrolimus Control  
STARTED     106     51     125  
COMPLETED     96     49     117  
NOT COMPLETED     10     2     8  
Death                 2                 0                 0  
Administrative problems                 5                 2                 2  
Lost to Follow-up                 0                 0                 3  
Withdrawal by Subject                 3                 0                 3  

Period 2:   Months 24 to 48 Post-transplantation
    Everolimus + Reduced Tacrolimus     Tacrolimus Elimination     Tacrolimus Control  
STARTED     106     51     0  
COMPLETED     95     47     0  
NOT COMPLETED     11     4     0  
Administrative problems                 5                 4                 0  
Withdrawal by Subject                 4                 0                 0  
Death                 2                 0                 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
Everolimus + Reduced Tacrolimus Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
Tacrolimus Elimination Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
Tacrolimus Control Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
Total Total of all reporting groups

Baseline Measures
    Everolimus + Reduced Tacrolimus     Tacrolimus Elimination     Tacrolimus Control     Total  
Number of Participants  
[units: participants]
  106     51     125     282  
Age  
[units: Years]
Mean ± Standard Deviation
  53.5  ± 9.57     54.9  ± 10.07     55.2  ± 8.10     54.5  ± 9.25  
Gender  
[units: Participants]
       
Female     29     18     38     85  
Male     77     33     87     197  



  Outcome Measures
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1.  Primary:   Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death   [ Time Frame: from months 24 to 36 ]

2.  Primary:   Incidence Rate of Composite Efficacy Failure Defined as Treated Biopsy Proven Acute Rejection (tBPAR ), Graft Loss or Death   [ Time Frame: from months 36 to 48 ]

3.  Primary:   Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death   [ Time Frame: from months 24 to 36 ]

4.  Primary:   Incidence Rate of Composite Efficacy Failure Defined as Graft Loss or Death   [ Time Frame: from months 36 - 48 ]

5.  Primary:   Change in Renal Function   [ Time Frame: from months 24 to 36 ]

6.  Secondary:   Incidence Rate of tBPAR   [ Time Frame: from months 24 - 36 ]


  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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  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.


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


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01150097     History of Changes
Other Study ID Numbers: CRAD001H2304E1, 2009-017311-15
Study First Received: April 23, 2010
Results First Received: May 1, 2014
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration