Envarsus, pharmocokinetic model, tacrolimus, liver transplantation, levertransplantatie
Conditions
Interventions
Advagraf is converted to Envarsus. After 3 weeks a whole PK curve is done. After 13 weeks a limited sampling AUC is done
Sponsors
LUMC
Eligibility
Inclusion criteria
Inclusion criteria: Liver transplant patients at least 6 months after transplantation Between 18 and 70 years old Stable on Advagraf based immunosuppressivum for at least 3 months with 2 months unchanged dose Stable graft function Able to give informed consent
Exclusion criteria
Exclusion criteria: Infections or complications at inclusion Bilirubin and albumin level outside clinical reference range Patients with GFR <30 ml/min at screening Unstable dosing of concomitant medication with known interaction with tacrolimus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Population pharmokinetic parameters tacrolimus (Envarsus) PK dependency on CYP3A5*3, CYP3A4*22 and IL polymorphisms | — |
Secondary
| Measure | Time frame |
|---|---|
| Limited PK sampling Through concentration - AUC correlation Changes in quality of life before and after conversion | — |
Contacts
Public ContactD.J.A.R. Moes
Outcome results
None listed