Kidney Transplantation
Conditions
Keywords
Tacrolimus, Sirolimus, Mycophenolic acid, Immunosuppressive Agents, Immunosuppression, Kidney Transplantation, Transplantation
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.
Interventions
DRUGsirolimus, tacrolimus, mycophenolate mofetil
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The influence of sirolimus on the pharmacokinetics of tacrolimus in renal transplant patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the outcome of tacrolimus/sirolimus and tacrolimus/mycophenolate in rejection prevention | — |
Countries
Taiwan
Contacts
Primary ContactMeng-Kun Tsai, MD, PhD
Backup ContactFe-Lin L Wu, PhD
Outcome results
None listed