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RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00267189
First received: December 19, 2005
Last updated: April 11, 2011
Last verified: April 2011
Results First Received: December 20, 2010  
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: Everolimus
Drug: Calcineurin inhibitors (CNI)
Drug: Mycophenolate acid (MPA)/ Azathioprine (AZA)
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
No text entered.

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
Group 1 (Everolimus) Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
Group 2 (Control) Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids

Participant Flow:   Overall Study
    Group 1 (Everolimus)   Group 2 (Control)
STARTED   72 [1]   73 
Completed Study Medication   54   72 
COMPLETED   67 [2]   72 
NOT COMPLETED   5   1 
Patient withdrew consent                1                1 
Death                1                0 
Missing                3                0 
[1] Intention to treat (ITT) population.
[2] "Completed" indicates completed study.



  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
Group 1 (Everolimus) Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
Group 2 (Control) Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
Total Total of all reporting groups

Baseline Measures
   Group 1 (Everolimus)   Group 2 (Control)   Total 
Overall Participants Analyzed 
[Units: Participants]
 72   73   145 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.0  (8.45)   57.8  (6.93)   57.4  (7.70) 
Age, Customized 
[Units: Paricipants]
     
< 40 years   1   2   3 
>= 40 - < 50 years   12   7   19 
>= 50 - < 60 years   29   33   62 
>= 60 years   30   31   61 
Gender 
[Units: Participants]
     
Female   27   33   60 
Male   45   40   85 


  Outcome Measures
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1.  Primary:   Mean Change From Baseline in Cockcroft-Gault Calculated Creatinine Clearance (CrCl)   [ Time Frame: From baseline to 6 months ]

2.  Secondary:   Percentage of Patients With Efficacy Failure (Biopsy Proven Acute Rejection [BPAR], Graft Loss or Death)   [ Time Frame: 6 months ]

3.  Secondary:   Number of Patients With Discontinuation of Study Medication   [ Time Frame: 6 months ]


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

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00267189     History of Changes
Other Study ID Numbers: CRAD001H2401
Study First Received: December 19, 2005
Results First Received: December 20, 2010
Last Updated: April 11, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)