Kidney Transplantation, Maintenance With Tacrolimus, Pediatric Patients
Conditions
Brief summary
This study was designed to compare the pharmacokinetics of Prograf and Advagraf in stable pediatric kidney transplant recipients. Enrolled patients on prograf will have pharmacokinetic study of tacrolimus for 24 hours and after that, the same dose of advagraf will be prescribed. The patients will have another pharmacokinetic study of tacrolimus after conversion to advagraf.
Interventions
DRUGtacrolimus
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* ABO-compatible kidney-only transplantation * more than 1 year after kidney transplantation * 5 to 15 years old * patients maintained on Prograf * tacrolimus level of determined previously: 4 to 20 ng/ml * eGFR by Schwartz equation \> 50mL/min
Exclusion criteria
* patients with acute rejection within 90 days * patients with acute rejection requiring antibody therapy within 6 months * patients with more than 2 times of acute rejection within 1 year * AST/ALT 2 times more than upper normal limit * ABO-incompatible or crossmatch-positive transplantation * multiorgan transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve of tacrolimus pharmacokinetics (AUC0-24) | — | The investigator will compare the changes in AUC0-24 of tacrolimus, Cmax, Tmax and correlation between C0 and Cmax |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Event | — |
Countries
South Korea
Outcome results
None listed