Status:
UNKNOWN
Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
Lead Sponsor:
Uniwersytet Mikolaja Kopernika w Toruniu
Collaborating Sponsors:
Astellas Pharma Inc
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate and compare, in the single center setting, the safety, efficacy and cost-effectiveness of the two standard immunosuppressive regimens based on tacrolimus and c...
Detailed Description
Despite several multicenter studies, there is no hard evidence on the superiority of a cyclosporine or tacrolimus based immunosuppressive regimen following kidney transplantation, in a single-center s...
Eligibility Criteria
Inclusion
- First or second cadaveric kidney transplantation
- Age over 18 years old
- Specific indications or contraindications for cyclosporine or tacrolimus are absent
- Informed consent
Exclusion
- Specific indications for use of cyclosporine or tacrolimus
- Specific contraindications for use of cyclosporine or tacrolimus
- Participation in another interventional clinical trial
- Pregnancy or lactation
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00204191
Start Date
May 1 2003
End Date
December 1 2007
Last Update
October 19 2007
Active Locations (1)
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1
Klinika Transplantologii, Szpital Uniwersytecki, ul. M. Sklodowskiej-Curie 9
Bydgoszcz, Poland, 85-084