Status:
COMPLETED
Study Comparing Cyclosporine Dose Reduction vs. Cyclosporine Elimination in Kidney Transplant Recipients Taking Sirolimus
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Kidney Failure
Graft vs Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Compare kidney function as measured by calculated creatinine clearance (using the method by Nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine mic...
Eligibility Criteria
Inclusion
- Subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related HLA-mismatched donor. Subjects must be at least 18 years of age.
Exclusion
- Subjects with active major infection, including active hepatitis B or C infection, decreased platelets, elevated lipids, or multiple organ transplants.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2006
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00195468
Start Date
March 1 2004
End Date
November 1 2006
Last Update
March 8 2011
Active Locations (13)
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1
Curitiba, Paraná, Brazil, 80730-150
2
Rio de Janeiro, Rio de Janeiro, Brazil, 21041-030
3
Rio de Janeiro, Rio de Janeiro, Brazil, 21941-590
4
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090