PEDIATRIC LIVER TRANSPLANTATION
Conditions
Interventions
Trade Name: Prograft
Pharmaceutical Form: Capsule
Trade Name: Prograft
Pharmaceutical Form: Capsule
Trade Name: Modigraf
Pharmaceutical Form: Granules for oral suspension in sachet
Trade Name: Modi
Sponsors
Cliniques universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Children aged 0 to 18 years old First liver transplant Patient eligible to receive tacrolimus post transplant Parents' approval to participate Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Multiorgan transplantation ABO incompatible patients (unless aged less than 1 year and AB antibody <1/32) Retransplantation Multi organ failure Introduction of tacrolimus administration postponed after day 3 post transplantation Need for additional steroid therapy except methylprednisolone to treat rejection Need for intraveinous tacrolimus Consent refusal or incapacity to understand the study procedures Retransplantation Multiorgan transplantation Introduction of tacrolimus administration postponed after
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Area Under the time-concentration Curve (AUC) ;Timepoint(s) of evaluation of this end point: - day 2-day 4 post transplant - day10-day 14 post tx - after day 21;Main Objective: The objective of this study is to progress in the understanding of tacrolimus (TAC) pharmacokinetics and its variability in pediatric transplantation. Our first aim is thus to investigate, retrospectively first and then prospectively, in de novo pediatric (living donor) liver recipients, the TAC 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. ;Secondary Objective: Our second aim is then to find better TAC exposure markers for therapeutic drug monitoring (TDM) such as Area Under the time-concentration Curve (AUC) or intralymphocytic (PBMCs) TAC 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): intralymphocytic (PBMCs) TAC concentration . ;Timepoint(s) of evaluation of this end point: - day 3 post transplant | — |
Countries
Belgium
Contacts
Public ContactProf Reding, principal investigator
Cliniques universitaires Saint-Luc
Outcome results
None listed