Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
Drug: sirolimus, cyclosporine, tacrolimus
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Effects of Conversion From Sirolimus Oral Solution to Tablets in Renal Transplant Recipients.|
- Pharmacokinetics of sirolimus tablets in different regimens in de novo renal transplant patients
- Effect of dosage form conversion on sirolimus concentration in stable renal transplant patients.
- Effectiveness of different sirolimus dose regimens in rejection prevention
|Study Start Date:||September 2002|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166842
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Study Chair:||Po-Huang Lee, MD PhD||National Taiwan University Hospital|