Status:
COMPLETED
Study Evaluating Sirolimus and Cyclosporine in Kidney Transplant Recipients
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Renal Transplantation
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving continuous therapy with cyclosporine (CsA, Sandimmune, Neoral) and sirolimus ve...
Eligibility Criteria
Inclusion
- End-stage renal disease, with patients receiving a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related (excluding 0 antigen mismatch) donor.
- Women who are of childbearing potential must have a negative pregnancy test before sirolimus administration and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of sirolimus
Exclusion
- Evidence of active systemic or localized major infection at the time of initial sirolimus administration
- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during pre-study screening.
- Chronic antiarrhythmic therapy for ventricular arrhythmia or other cardiac abnormality contraindicating general anesthesia or surgery
Key Trial Info
Start Date :
May 1 1998
Trial Type :
INTERVENTIONAL
End Date :
June 1 2004
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00428064
Start Date
May 1 1998
End Date
June 1 2004
Last Update
January 29 2007
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