Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients

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NCT00086346

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Study Location
San Francisco, California, 94143-0780, United States
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Contact
1-800-718-1021
Clini[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Liver Transplantation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age greater than 13 years (age greater than 18 years as required by some local regulations).

- Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.

- 6 to 144 months after orthotopic liver transplantation.

- Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- History of nonhepatic transplantation


- Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).


- Known or suspected malignancy < 5 years before random assignment.

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Liver TransplantationStudy Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
NCT00086346
  1. San Francisco, California
  2. Tampa, Florida
  3. New Orleans, Louisiana
  4. Detroit, Michigan
  5. Rochester, Minnesota
  6. Omaha, Nebraska
  7. New York, New York
  8. Rochester, New York
  9. Cleveland, Ohio
  10. Philadelphia, Pennsylvania
  11. Gent,
  12. Edmonton, Alberta
  13. London, Ontario
  14. Toronto, Ontario
  15. Prague,
  16. Clichy,
  17. Lyon,
  18. Nice,
  19. Paris,
  20. Rennes,
  21. Villejuif,
  22. Berlin,
  23. Hamburg,
  24. München,
  25. Bologna,
  26. Milano,
  27. Padova,
  28. Leiden,
  29. Coimbra,
  30. Lisboa,
  31. Barcelona,
  32. Barcelona,
  33. Barcelona,
  34. Madrid,
  35. Pamplona,
  36. Santiago de Compostela,
  37. Valencia,
  38. Bern,
  39. Zürich,
  40. Birmingham,
  41. Edinburgh,
  42. Leeds,
ALL GENDERS
13 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
Official Title  ICMJE A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy
Brief Summary The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Transplantation
Intervention  ICMJE
  • Drug: Sirolimus (Rapamune)
  • Drug: Cyclosporine or Tacrolimus
Study Arms  ICMJE
  • Active Comparator: A
    Intervention: Drug: Sirolimus (Rapamune)
  • Active Comparator: B
    Intervention: Drug: Cyclosporine or Tacrolimus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 31, 2009)		607
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age greater than 13 years (age greater than 18 years as required by some local regulations).
  • Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.
  • 6 to 144 months after orthotopic liver transplantation.
  • Cockcroft-Gault GFR values ?40 mL/min and ?90mL/min at screening

Exclusion Criteria:

  • History of nonhepatic transplantation
  • Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
  • Known or suspected malignancy < 5 years before random assignment.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czech Republic,   France,   Germany,   Italy,   Netherlands,   Portugal,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00086346
Other Study ID Numbers  ICMJE 0468H1-313
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:Trial ManagerFor Italy, [email protected]
Principal Investigator:Trial ManagerFor Germany, [email protected]
Principal Investigator:Trial ManagerFor Belgium, [email protected]
Principal Investigator:Trial ManagerFor Czech Republic, [email protected]
Principal Investigator:Trial ManagerFor Netherlands, [email protected]
Principal Investigator:Trial ManagerFor Switzerland, [email protected]
Principal Investigator:Trial ManagerFor UK, [email protected]
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP