NCT00166816

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (planned)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 13 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Transplantation
• Kidney Transplantation
• Immunosuppression

Interventions

Type	Name	Description
DRUG	sirolimus, cyclosporine, tacrolimus

Timeline

• Start date: 2002-03-01
• Completion: 2003-06-01
• First posted: 2005-09-14
• Last updated: 2005-09-14

Locations

1 site across 1 country: Taiwan