NCT00166842

Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets

Effects of Conversion From Sirolimus Oral Solution to Tablets in Renal Transplant Recipients.

• 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 pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.

Detailed description

Sirolimus tablets will be available more than one year after the launch of sirolimus solution. Most patients on sirolimus solution will use sirolimus tablet instead. The purpose of this study is to understand the pharmacokinetics of sirolimus tablets in different regimens in newly renal transplant patients, and the effect of dosage form conversion on the concentration of sirolimus in stable renal transplant patients. So that we can design a better tacrolimus or cyclosporine/sirolimus/steroid dose regimen for Taiwanese.

Conditions

• Transplantation
• Kidney Transplantation
• Immunosuppression

Interventions

Type	Name	Description
DRUG	sirolimus, cyclosporine, tacrolimus

Timeline

• Start date: 2002-09-01
• First posted: 2005-09-14
• Last updated: 2005-09-14

Locations

1 site across 1 country: Taiwan