Status:
COMPLETED
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A study to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney transplant patients converted from a Prograf® based immunosuppression regimen to a modified release tacr...
Detailed Description
This is a Phase II open-label, multi-center conversion study in stable, adult kidney transplant recipients to assess the pharmacokinetics, safety and effectiveness of tacrolimus in stable kidney trans...
Eligibility Criteria
Inclusion
- Patient is currently receiving Prograf ® based immunosuppressive therapy for kidney transplantation.
- Patient has stable whole blood trough level concentrations of Prograf® and is clinically stable
Exclusion
- Patient has previously received an organ transplant other than a kidney
- Patient is currently receiving sirolimus immunosuppression therapy.
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00282568
Start Date
August 1 2002
End Date
October 1 2008
Last Update
September 26 2013
Active Locations (9)
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1
San Diego, California, United States
2
Miami, Florida, United States, 33136
3
Minneapolis, Minnesota, United States, 55455
4
Cincinnati, Ohio, United States, 45267