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Sirolimus Conversions in African-American Renal Transplant Recipients

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01005706
First received: October 9, 2009
Last updated: February 12, 2016
Last verified: February 2014
Results First Received: May 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Absence; Kidney
Interventions: Drug: rapamune, mycophenolate mofetil and steroid
Drug: tacrolimus, sirolimus and steroid

  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
Tacrolimus Withdrawal Arm

At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.

Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator.

Tacrolimus Minimization Arm

Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.

At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.


Participant Flow:   Overall Study
    Tacrolimus Withdrawal Arm   Tacrolimus Minimization Arm
STARTED   23   17 
COMPLETED   23   17 
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.
No text entered.

Reporting Groups
  Description
Tacrolimus Withdrawal Arm

At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.

Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator.

Tacrolimus Minimization Arm

Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.

At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.

Total Total of all reporting groups

Baseline Measures
   Tacrolimus Withdrawal Arm   Tacrolimus Minimization Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 23   17   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 51  (14)   54  (11)   52  (13) 
Gender 
[Units: Participants]
     
Female   4   9   13 
Male   19   8   27 


  Outcome Measures

1.  Primary:   Effectiveness and Safety of a Particular Drug Regimen to Prevent Kidney Rejection   [ Time Frame: 12 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 NOT 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.


Results Point of Contact:  
Name/Title: Charles F. Bratton, MD
Organization: Medical University of South Carolina
phone: 843-792-4003
e-mail: brattocf@musc.edu


Publications:


Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01005706     History of Changes
Other Study ID Numbers: Wyeth Study - HR 19042
HR19042
Study First Received: October 9, 2009
Results First Received: May 14, 2015
Last Updated: February 12, 2016
Health Authority: United States: Institutional Review Board