Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients
Status:
Recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
Summary
Trial participants are randomised within 14 days after liver transplantation surgery in a 1:1
ratio to two alternative treatment arms containing either Envarsus® (test arm) or Advagraf®
(comparator arm) as first-line calcineurin inhibitor within a standard-of-care
immunosuppressive regimen. Tacrolimus blood trough levels and drug doses are monitored at
regular intervals to assess drug bioavailability and the ease and accuracy of achieving the
targeted blood concentration range. Dose-normalised trough level (concentration/dose ratio)
is measured at 12 weeks post-randomisation as an estimate of tacrolimus bioavailability. It
is hypothesised that treatment with Envarsus® will confer a superior (higher) C/D ratio after
12 weeks of therapy owing to the superior bioavailability of this galenic drug formulation
(proprietary MeltDose® technology). To test whether an elevated C/D ratio is also associated
with improved clinical outcomes, a range of other pharmacokinetic, efficacy and safety
variables are evaluated at 10 study visits spanning a period of 3 years.