Study Evaluating Rapamune® Maintenance Regimen

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00478608
First received: May 24, 2007
Last updated: April 22, 2010
Last verified: April 2010
Results First Received: November 30, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Renal Transplant
Intervention: Drug: Sirolimus (Rapamune®)

  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
Patients were recruited in Korea from March 2007 to November 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were screened up to 7 days.

Reporting Groups
  Description
Sirolimus (SRL)

Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.

On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.

CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.

Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.


Participant Flow:   Overall Study
    Sirolimus (SRL)  
STARTED     79  
COMPLETED     59  
NOT COMPLETED     20  
Adverse Event                 1  
Serious Adverse Event                 14  
Withdrawal by Subject                 2  
Protocol Violation                 3  



  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
Sirolimus (SRL)

Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.

On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.

CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.

Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited.


Baseline Measures
    Sirolimus (SRL)  
Number of Participants  
[units: participants]
  79  
Age  
[units: years]
Mean ± Standard Deviation
  40.16  ± 12.69  
Gender  
[units: patients]
 
Female     47  
Male     32  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 6 After Transplantation.   [ Time Frame: 6 months after transplantation ]

2.  Secondary:   Glomerular Filtration Rate (GFR) (Nankivell Method)   [ Time Frame: 6 and 12 months ]

3.  Secondary:   Serum Creatinine   [ Time Frame: Baseline, 6 and 12 months ]

4.  Secondary:   Patient and Graft Survival   [ Time Frame: 12 months ]

5.  Secondary:   Number of Patients Experiencing Biopsy Confirmed Acute Rejection Through Month 12 After Transplantation   [ Time Frame: 12 months after transplantation ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.  


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


No publications provided


Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00478608     History of Changes
Other Study ID Numbers: 0468E-102362
Study First Received: May 24, 2007
Results First Received: November 30, 2009
Last Updated: April 22, 2010
Health Authority: Korea: Food and Drug Administration