Prospective Tacrolimus Pharmacokinetics Study in Pediatric Living Donor Liver Transplantation

Tacrolimus Disposition in Pediatric Transplantation: Influence of Age, Genetic Polymorphisms, Intestinal and Hepatic Relative Contribution on Pharmacokinetics, in Relationship With Clinical Outcomes

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02064777

Enrollment

Registered

2014-02-17

Start date

2013-07-31

Completion date

2014-09-30

Last updated

2014-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Liver Transplantation

Brief summary

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.

Interventions

DRUGTacrolimus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Area Under the Time Concentration curve	day 2-day 4; day 10-day 1; > day 21

Secondary

Measure	Time frame
Intralymphocytic tacrolimus concentration	Day 3

Countries

Belgium

Contacts

Primary ContactVanessa Guy-Viterbo, MD

vanessa.guy@uclouvain.be003227649472

Backup ContactRaymond Reding, MD-PhD

raymond.reding@uclouvain.be003227641401

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026