Status:
TERMINATED
Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Liver Transplantation
Eligibility:
All Genders
13+ years
Phase:
PHASE3
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 subj...
Eligibility Criteria
Inclusion
- 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
- History of nonhepatic transplantation
- Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
- Known or suspected malignancy \< 5 years before random assignment.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT00086346
Start Date
December 1 2002
End Date
July 1 2008
Last Update
April 28 2010
Active Locations (42)
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1
San Francisco, California, United States, 94143-0780
2
Tampa, Florida, United States, 33606
3
New Orleans, Louisiana, United States, 70121
4
Detroit, Michigan, United States, 48202