Pharmacokinetics, Effectiveness and Tolerability of Prolonged-release Tacrolimus After Paediatric Kidney Transplantation
Status:
Recruiting
Trial end date:
2025-03-01
Target enrollment:
Participant gender:
Summary
Recently, a new prolonged-release tablet version of tacrolimus (Envarsus®) using the
so-called MeltDose™ (US Patent No. 7,217,431) drug-delivery technology has been approved as
immunosuppressive medication for patients after kidney and liver transplantation in adults
but not yet in children. Studies in adults proved that Envarsus® provides the same
therapeutic effectiveness as the conventional immediate-release tacrolimus formulation
(Prograf®) with improved bioavailability, a more consistent pharmacokinetic profile and
reduced peak to trough which might result in reduced tacrolimus dosing and subsequently
reduced CNI related toxicity. Furthermore, the once daily formulation might result in
improved drug adherence.
The aim of this study is to assess pharmacokinetic profiles of Envarsus® as well as
effectiveness and tolerability of this drug in children and adolescents ≥ 8 and ≤ 18 years of
age.