Status:
COMPLETED
Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Graft Rejection
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy ...
Eligibility Criteria
Inclusion
- Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant.
- 12 months after cardiac transplantation but less than 96 months post-transplantation.
Exclusion
- Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients).
- Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days.
- History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00369382
Start Date
September 1 2006
End Date
May 1 2010
Last Update
May 30 2011
Active Locations (23)
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1
Pfizer Investigational Site
Tampa, Florida, United States, 33606
2
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
3
Pfizer Investigational Site
New York, New York, United States, 10027-6902
4
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19102