levertransplantatie liver transplantation
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patient is recipient of a liver transplant at least 6 months prior to entry into the study. 2. Patients are between 18 and 70 years old. 3. Patient is stable on an Advagraf (tacrolimus) based immunosuppressive regimen for at least 3 months. 4. The Advagraf based immunosuppressive regimen remained unchanged for a minimum of 2 months prior to enrolment. 5. The function of the graft is stable. 6. Patients capable of understanding the purpose and risks of the study, has been fully informed and has given written informed consent to participate in the study and at time of conversion. 7. Patients haven*t infections or other complications during inclusion into the study.
Exclusion criteria
Exclusion criteria: 1. Patient with infections or other complications during inclusion. 2. Patients with direct bilirubin >10 µmol/L or albumin level outside the clinical reference range. 3. Patients allergic or hypersensitive to tacrolimus 4. Patients with an estimated glomerular filtration rate (eGFR)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| a: Population Pharmacokinetic parameters of tacrolimus (Envarsus) b: PK dependency on CYP3A5*3, CYP3A4*22 and IL genotypes of recipient and of donor. | — |
Secondary
| Measure | Time frame |
|---|---|
| a: Limited PK samplingmodel for accurate AUC estimation b: Trough - AUC correlation c:: Changes in Quality of Life before and after conversion. | — |
Countries
Netherlands
Outcome results
None listed