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Prospective Tacrolimus Pharmacokinetics Study in Pediatric Living Donor Liver Transplantation

NCT02064777 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-02-17

No results posted yet for this study

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.

Conditions

  • Pediatric Liver Transplantation

Interventions

DRUG

Tacrolimus

Sponsors & Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-06-30
Completion
2014-09-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02064777 on ClinicalTrials.gov