The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients
This trial is active, not recruiting.
|Conditions||transplantation, kidney transplantation, immunosuppression|
|Treatment||sirolimus, cyclosporine, tacrolimus|
|Sponsor||National Taiwan University Hospital|
|Start date||March 2002|
|End date||June 2003|
|Trial size||40 participants|
|Trial identifier||NCT00166816, 900604, NTUH S010|
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 appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||parallel assignment|
Pharmacokinetics of sirolimus in different regimens
Dose-concentration relationship of sirolimus
Efficacy of rejection prevention
Dosage regimen of sirolimus + cyclosporine or tacrolimus
Dose-concentration relationship of cyclosporine/tacrolimus
Male or female participants from 13 years up to 65 years old.
Inclusion Criteria: - De novo kidney transplantation patients, aged 13－65 years,have aminotransferase concentrations within 2 times the upper limit of normal. Exclusion Criteria: - pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus－positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis.
|Official title||The Pharmacokinetics and Dosage Regimen of Sirolimus in a Cyclosporine or Tacrolimus-Based Immunosuppression in Renal Transplant Patients|
|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 through pharmacokinetic study. The dose-level relationship of cyclosporine and tacrolimus was also assessed. From clinical outcome and blood level of sirolimus and cyclosporine or tacrolimus, we can design the most appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.|
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