Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets
|ClinicalTrials.gov Identifier: NCT00166842|
Recruitment Status : Unknown
Verified July 2002 by National Taiwan University Hospital.
Recruitment status was: Active, not recruiting
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
|Condition or disease||Intervention/treatment||Phase|
|Transplantation Kidney Transplantation Immunosuppression||Drug: sirolimus, cyclosporine, tacrolimus||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Conversion From Sirolimus Oral Solution to Tablets in Renal Transplant Recipients.|
|Study Start Date :||September 2002|
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166842
|National Taiwan University Hospital|
|Taipei, Taiwan, 100|
|Study Chair:||Po-Huang Lee, MD PhD||National Taiwan University Hospital|