Kidney Transplantation
Conditions
Keywords
Kidney transplant, Kidney transplantation, Renal transplant, Renal transplantation
Brief summary
Pharmacokinetic model to predict interaction between tacrolimus and mycophenolate was developed through clinical trial with healthy volunteer. The purpose of this study is to confirm predictability of developed pharmacokinetic model in kidney transplant recipients.
Detailed description
Study participants take their immunosuppressant as usual. One day, blood is drawn at predose and 1, 2, 3, 4-hour postdose to compare observed concentration with model-predicted concentration of tacrolimus and mycophenolate.
Interventions
DRUGTacrolimus
Administered dose were individualized according to their own prescription
DRUGMycophenolate mofetil
Administered dose were individualized according to their own prescription
Sponsors
Ministry of Food and Drug Safety, Korea
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age of 18 years or older * At least 6 months after kidney transplantation * Were on tacrolimus alone or tacrolimus plus mycophenolate based immunosuppressive regimen * Maintained stable dose of immunosuppressants for at least two weeks
Exclusion criteria
* AST or ALT \>3 upper limit of normal range * Had gastrointestinal disorder that may affect an absorption of drug * Coadministration of drugs that may affect the pharmacokinetics of immunosuppressive drug * Multi-organ transplant recipient * Severe psychiatric disorder * Drug or alcohol abuser * Pregnant * Low compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tacrolimus concentration | 0, 1, 2, 3, 4 hours post-dose |
Secondary
| Measure | Time frame |
|---|---|
| Mycophenolate concentration | 0, 1, 2, 3, 4 hours post-dose |
Countries
South Korea
Contacts
Primary ContactJae Hyun Kim
Outcome results
None listed