The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
Phase 4
- Conditions
- Kidney Transplantation
- Registration Number
- NCT00166829
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
- Detailed Description
The controlled clinical trial held in NTUH in 2001 revealed that the bioavailability of tacrolimus when combined with sirolimus is lower than that reported in the literature where tacrolimus was not combined with sirolimus. To determine if the difference was due to the drug interaction between sirolimus and tacrolimus, a controlled clinical trial was proposed.
The purpose of this study is to understand whether the pharmacokinetics of tacrolimus is influenced by the concurrent use of sirolimus.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- De novo kidney transplant patients
- Aged 13 - 65 years
- Having aminotransferase concentrations within 2 times the upper limit of normal
Exclusion Criteria
- Pregnancy
- Tuberculosis
- Hepatitis B or C carrier status
- Human immunodeficiency virus-positive status
- Retransplantation or multi-organ transplantation
- History of rheumatoid arthritis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients
- Secondary Outcome Measures
Name Time Method Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention
Trial Locations
- Locations (1)
National Taiwan University Hospital
🇨🇳Taipei, Taiwan