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ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170846
First received: September 9, 2005
Last updated: March 31, 2011
Last verified: March 2011
History of Changes
Results First Received: December 17, 2010  
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 (RAD001)
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
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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
Group A: No RAD Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
Group B : CNI Withdrawal Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
Group C: CNI Reduction Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.

Participant Flow:   Overall Study
    Group A: No RAD     Group B : CNI Withdrawal     Group C: CNI Reduction  
STARTED     123     127     144  
COMPLETED     112     108     131  
NOT COMPLETED     11     19     13  
Subject withdrew Informed Consent                 5                 12                 8  
Lost to Follow-up                 6                 3                 2  
Death                 0                 3                 3  
Reason Missing                 0                 1                 0  



  Baseline Characteristics
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Reporting Groups
  Description
Group A: No RAD Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
Group B : CNI Withdrawal Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
Group C: CNI Reduction Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
Total Total of all reporting groups

Baseline Measures
    Group A: No RAD     Group B : CNI Withdrawal     Group C: CNI Reduction     Total  
Number of Participants  
[units: participants]
 		  123     127     144     394  
Age  
[units: years]
Mean ± Standard Deviation 		  48.2  ± 12.18     49.4  ± 11.81     49.7  ± 12.95     49.1  ± 12.34  
Gender  
[units: participants]
 		       
Female     41     41     53     135  
Male     82     86     91     259  
Time since transplantation  
[units: years]
Mean ± Standard Deviation 		  5.8  ± 4.14     5.4  ± 4.28     5.4  ± 3.99     5.6  ± 4.13  



  Outcome Measures
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1.  Primary:   Renal Function Assessed by Measured GFR (mGFR)   [ Time Frame: 24 months ]
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2.  Secondary:   Number of Participants With Safety Parameters   [ Time Frame: 24 months ]
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3.  Post-Hoc:   Change in mGFR by Baseline Calculated Creatinine Clearance (Cockcroft-Gault Formula)   [ Time Frame: Baseline and 24 months ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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
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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: NCT00170846     History of Changes
Other Study ID Numbers: CRAD001A2413
Study First Received: September 9, 2005
Results First Received: December 17, 2010
Last Updated: March 31, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health