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NCT00166816 Clinical Trial

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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00166816
Other study ID # 900604
Secondary ID NTUH S010
Status Active, not recruiting
Phase Phase 4
First received September 12, 2005
Last updated September 12, 2005
Start date March 2002
Est. completion date June 2003

Study information
Verified date July 2001
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 40
Est. completion date June 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• sirolimus, cyclosporine, tacrolimus

Locations
Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Wu FL, Tsai MK, Chen RR, Sun SW, Huang JD, Hu RH, Chen KH, Lee PH. Effects of calcineurin inhibitors on sirolimus pharmacokinetics during staggered administration in renal transplant recipients. Pharmacotherapy. 2005 May;25(5):646-53. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics of sirolimus in different regimens
Primary Dose-concentration relationship of sirolimus
Secondary Efficacy of rejection prevention
Secondary Dosage regimen of sirolimus + cyclosporine or tacrolimus
Secondary Dose-concentration relationship of cyclosporine/tacrolimus
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