Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
- Conditions
- TransplantationKidney TransplantationImmunosuppression
- Registration Number
- NCT00166842
- Lead Sponsor
- National Taiwan University Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- ages of 18 and 65, renal transplant patients
- pregnancy, tuberculosis, hepatitis B or C carrier status, human immunodeficiency virus-positive status, retransplantation or multiorgan transplantation, or history of rheumatoid arthritis before transplantation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Effectiveness of different sirolimus dose regimens in rejection prevention
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan