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Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients (RAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00622869
First received: February 13, 2008
Last updated: May 17, 2013
Last verified: May 2013
Results First Received: April 2, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Liver Transplantation
Interventions: Drug: Tacrolimus (reduced tacrolimus)
Drug: Tacrolimus (tacrolimus elimination)
Drug: Tacrolimus (tacrolimus control)
Drug: Everolimus (reduced tacrolimus)
Drug: Everolimus (tacrolimus elimination)
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
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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 + Reduced Tacrolimus Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
Tacrolimus Elimination Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
Tacrolimus Control Arm Control dose tacrolimus + corticosteroids.

Participant Flow:   Overall Study
    Everolimus + Reduced Tacrolimus   Tacrolimus Elimination   Tacrolimus Control Arm
STARTED   245   231   243 
COMPLETED   202   174   204 
NOT COMPLETED   43   57   39 
Subject Withdrew Consent                13                17                11 
Administrative Problems                11                17                13 
Death                12                15                10 
Lost to Follow-up                2                4                2 
Graft Loss                5                3                2 
Missing                0                1                1 



  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.
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Reporting Groups
  Description
Everolimus + Reduced Tacrolimus Low dose tacrolimus (tacrolimus reduced) + everolimus + corticosteroids.
Tacrolimus Elimination Low-dose tacrolimus (until Month 4, then tacrolimus eliminated) + everolimus + corticosteroids.
Tacrolimus Control Arm Control dose tacrolimus + corticosteroids.
Total Total of all reporting groups

Baseline Measures
   Everolimus + Reduced Tacrolimus   Tacrolimus Elimination   Tacrolimus Control Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 245   231   243   719 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.6  (9.2)   53.2  (10.8)   54.5  (8.7)   53.8  (9.6) 
Gender 
[Units: Participants]
       
Female   65   67   64   196 
Male   180   164   179   523 


  Outcome Measures
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1.  Primary:   Incidence Rate of Composite Efficacy Failure From Randomization to Month 12   [ Time Frame: Randomization to Month 12 ]

2.  Secondary:   Incidence Rate of Composite Efficacy Failure From Randomization to Month 24   [ Time Frame: Randomization to Month 24 ]

3.  Secondary:   Incidence Rate of Treated Biopsy Proven Acute Rejection (tBPAR) at Months 12 and 24   [ Time Frame: Randomization to Month 24 ]

4.  Secondary:   Change in Renal Function From Randomization to Months 12 and 24   [ Time Frame: Randomization to Month 24 ]


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00622869     History of Changes
Other Study ID Numbers: CRAD001H2304
2007-001821-85 ( EudraCT Number )
Study First Received: February 13, 2008
Results First Received: April 2, 2013
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency