Status:
UNKNOWN
The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Transplantation
Kidney Transplantation
Eligibility:
All Genders
13-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to understand the pharmacokinetic of sirolimus in different regimens, as well as the dose-level relationship of cyclosporine and tacrolimus, and design the most appropriat...
Detailed Description
The dose and pharmacokinetic of an immunosuppressant may differ in different ethnics, and different combinations. The purpose of this study is to determine the dose-level relationship of sirolimus th...
Eligibility Criteria
Inclusion
- De novo kidney transplantation patients, aged 13-65 years,have aminotransferase concentrations within 2 times the upper limit of normal.
Exclusion
- pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus-positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2003
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00166816
Start Date
March 1 2002
End Date
June 1 2003
Last Update
September 14 2005
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100