Efficacy and Safety of Early Versus Delayed Administration of Everolimus in de Novo Renal Transplant Patients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00154297
First received: September 8, 2005
Last updated: March 30, 2011
Last verified: March 2011
Results First Received: January 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Renal Transplantation
Intervention: Drug: Everolimus (RAD001)

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Immediate Everolimus Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
Delayed Everolimus Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.

Participant Flow:   Overall Study
    Immediate Everolimus     Delayed Everolimus  
STARTED     65 [1]   74 [1]
COMPLETED     57 [2]   67 [2]
NOT COMPLETED     8     7  
Death                 5                 2  
Withdrawal by Subject                 0                 5  
Lost to Follow-up                 3                 0  
[1] Randomized population.
[2] Completed study by 12 month.



  Baseline Characteristics
  Hide Baseline Characteristics

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
Immediate Everolimus Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
Delayed Everolimus Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
Total Total of all reporting groups

Baseline Measures
    Immediate Everolimus     Delayed Everolimus     Total  
Number of Participants  
[units: participants]
  65     74     139  
Age [1]
[units: years]
Mean ± Standard Deviation
  57.3  ± 10.46     58.4  ± 9.86     57.9  ± 10.13  
Gender [1]
[units: participants]
     
Female     19     20     39  
Male     46     54     100  
[1] baseline measure based on randomized population.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Considered in Failure for the Primary Failure Endpoint at 3 Months   [ Time Frame: Month 3 ]

2.  Secondary:   Number of Participants Considered in Failure for the Primary Failure Endpoint at 6 Months Post-transplantation.   [ Time Frame: at 6 Month post-transplantation ]

3.  Secondary:   Number of Participants Considered in Failure for the Primary Failure Endpoint at 12 Months Post-transplantation.   [ Time Frame: at 12 Month post-transplantation ]

4.  Secondary:   Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period   [ Time Frame: Month 12 ]
  Hide Outcome Measure 4

Measure Type Secondary
Measure Title Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period
Measure Description The number of patients who underwent any dialysis within the 12-month treatment period.
Time Frame Month 12  
Safety Issue No  

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.
Intention to treat (ITT) population.

Reporting Groups
  Description
Immediate Everolimus Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
Delayed Everolimus Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.

Measured Values
    Immediate Everolimus     Delayed Everolimus  
Number of Participants Analyzed  
[units: participants]
  65     74  
Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period  
[units: Participants]
  16     24  

No statistical analysis provided for Number of Participants Who Underwent Any Dialysis Within the 12-month Treatment Period



5.  Secondary:   Duration of Dialysis   [ Time Frame: 12 months ]

6.  Secondary:   Number of Participants With Any Wound Healing Disorder During the 12-month Treatment Period   [ Time Frame: Month 12 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

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
No text entered.  


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: NCT00154297     History of Changes
Other Study ID Numbers: CRAD001A2420
Study First Received: September 8, 2005
Results First Received: January 4, 2011
Last Updated: March 30, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)