Pediatric Liver Transplantation Clinical Trial
Official title:
Tacrolimus Disposition in Pediatric Transplantation: Influence of Age, Genetic Polymorphisms, Intestinal and Hepatic Relative Contribution on Pharmacokinetics, in Relationship With Clinical Outcomes
Our first aim is thus to investigate, retrospectively first and then prospectively, in de
novo pediatric (living donor) liver recipients, the tacrolimus in vivo and in vitro
metabolism and its variability with focus on pharmacokinetics, pharmacodynamics, and
pharmacogenomics and its evolution according to the age and transplant delay. Our second aim
is then to find better tacrolimus exposure markers for therapeutic drug monitoring (TDM)
such as Area Under the time-concentration Curve (AUC) or intralymphocytic (PBMCs) tacrolimus
concentration and a way to model and predict it without invasive tests in pediatric
patients.
The final objective should be then to implement these findings in a more individualized and
comprehensive immunosuppression protocol and monitoring in order to maintain adequate and
well-balanced immunosuppression (preventing graft rejection while avoiding acute and
long-term side effects). This is particularly important for a pediatric population exposed
throughout their life to immunosuppressants.
n/a
Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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