The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients
Recruitment status was Active, not recruiting
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.
Drug: sirolimus, cyclosporine, tacrolimus
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||The Pharmacokinetics and Dosage Regimen of Sirolimus in a Cyclosporine or Tacrolimus-Based Immunosuppression in Renal Transplant Patients|
- 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
|Study Start Date:||March 2002|
|Estimated Study Completion Date:||June 2003|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166816
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Study Chair:||Po-Huang Lee||National Taiwan University Hospital|