Overview

This trial is active, not recruiting.

Conditions transplantation, kidney transplantation, immunosuppression
Treatment sirolimus, cyclosporine, tacrolimus
Phase phase 4
Sponsor National Taiwan University Hospital
Start date March 2002
End date June 2003
Trial size 40 participants
Trial identifier NCT00166816, 900604, NTUH S010

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 appropriate cyclosporine/sirolimus/steroid or tacrolimus/sirolimus/steroid dose regimen for Taiwanese.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

Measure
Pharmacokinetics of sirolimus in different regimens
time frame:
Dose-concentration relationship of sirolimus
time frame:

Secondary Outcomes

Measure
Efficacy of rejection prevention
time frame:
Dosage regimen of sirolimus + cyclosporine or tacrolimus
time frame:
Dose-concentration relationship of cyclosporine/tacrolimus
time frame:

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by National Taiwan University Hospital.