Status:
COMPLETED
Study Comparing Cyclosporin Dose Reduction With Cyclosporin Elimination in Kidney Transplant Recipients Taking Sirolimus
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
To assess equivalence in the rates of functional graft survival at 12 months after transplantation in patients receiving induction therapy with cyclosporin (CsA, Neoral) and Rapamune® followed by CsA ...
Eligibility Criteria
Inclusion
- Age: = to ≥ 18 years.
- End-stage renal disease, with patients scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or from a living-related donor.
- Patients with second and subsequent transplants must have maintained their primary graft for at least 6 months after transplantation (with the exception of graft failure due to technical reasons).
Exclusion
- Evidence of active systemic or localised major infection prior to initial Rapamune® administration.
- Evidence of infiltrate, cavitation, or consolidation on chest x-ray obtained during screening.
- Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the 12-month treatment phase. Exception: the use of erythropoiesis stimulating products. In these cases, erythrocyte-stimulating products must be discontinued prior to administration of Rapamune®.
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
End Date :
October 1 2007
Estimated Enrollment :
470 Patients enrolled
Trial Details
Trial ID
NCT00248313
Start Date
July 1 2000
End Date
October 1 2007
Last Update
March 10 2010
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