The Pharmacokinetics of Sirolimus When Combined With Cyclosporine or Tacrolimus in Renal Transplant Patients

Condition(s) targeted: Transplantation; Kidney Transplantation; Immunosuppression

Intervention: sirolimus, cyclosporine, tacrolimus (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: National Taiwan University Hospital

Official(s) and/or principal investigator(s):
Po-Huang Lee, Study Chair, Affiliation: National Taiwan University Hospital

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.

Official title: The Pharmacokinetics and Dosage Regimen of Sirolimus in a Cyclosporine or Tacrolimus-Based Immunosuppression in Renal Transplant Patients

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study

Primary outcome:

Pharmacokinetics of sirolimus in different regimens

Dose-concentration relationship of sirolimus

Secondary outcome:

Efficacy of rejection prevention

Dosage regimen of sirolimus + cyclosporine or tacrolimus

Dose-concentration relationship of cyclosporine/tacrolimus

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 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.

Minimum age: 13 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

National Taiwan University Hospital, Taipei 100, Taiwan

Starting date: March 2002
Ending date: June 2003
Last updated: September 12, 2005