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Mycophenolate Mofetil and Rapamycin as Secondary Intervention vs. Continuation of Calcineurin Inhibitors in Patients at Risk for Chronic Renal Allograft Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anthony Langone, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT00223678
First received: September 19, 2005
Last updated: May 24, 2017
Last verified: May 2017
Results First Received: February 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Kidney Transplant
Intervention: Drug: Rapamycin

  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
No text entered.

Reporting Groups
  Description
Rapamycin

pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin

Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15

CYA/Prograf Patient will remain on calcineurin inhibitor,CYA/Prograf

Participant Flow:   Overall Study
    Rapamycin   CYA/Prograf
STARTED   13   7 
COMPLETED   13   7 
NOT COMPLETED   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.
approximately 30 patients will be randomized in a 2:1 ratio: two patients will be converted to Rapamycin-based immunosuppression for each patient randomized to continue calcineurin inhibitor based immunosuppression.

Reporting Groups
  Description
Rapamycin

pt will switch from calcineurin inhibitor (CYA, prograf) to Rapamycin

Rapamycin: Rapamycin will start within 24 hours of last calcineurin inhibitors (Cya, Prograf). Initial dose of Rapamune 10mg will be given for 3 days and then dose will be adjusted to attain a target whole blood trough of 5-15

CYA/Prograf Patient will remain on calcineurin inhibitor,CYA/Prograf
Total Total of all reporting groups

Baseline Measures
   Rapamycin   CYA/Prograf   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   7   20 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      13 100.0%      7 100.0%      20 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  38.5%      1  14.3%      6  30.0% 
Male      8  61.5%      6  85.7%      14  70.0% 
Region of Enrollment 
[Units: Participants]
     
United States   13   7   20 


  Outcome Measures

1.  Primary:   Graft Survival   [ Time Frame: 3 years ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Anthony Langone
Organization: Vanderbilt Medical Center
phone: 615-936-1179
e-mail: anthony.langone@vanderbilt.edu



Responsible Party: Anthony Langone, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00223678     History of Changes
Other Study ID Numbers: 000294
Study First Received: September 19, 2005
Results First Received: February 21, 2017
Last Updated: May 24, 2017