Prospective Tacrolimus Pharmacokinetics Study in Pediatric Living Donor Liver Transplantation

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase

Unknown

Phase 4

Conditions

Pediatric Liver Transplantation

Treatments

Drug: Tacrolimus

Study type

Interventional

Funder types

Other

Identifiers

NCT02064777

2012MAR19

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Children aged 0 to 18 years
First Liver transplantation
Children eligible to receive tacrolimus post transplantation
Consent from parents

Exclusion criteria

Multiorgan transplantation
Retransplantation
ABO incompatible donors (unless if recipients is<1 year and anti-AB antibodies are <1/32)
Multi organ failure
Need for additionnal therapy except for methylprednisolone to treat rejection
Intravenous tacrolimus
First tacrolimus administration postponed after day 3