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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02064777
Study type Interventional
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact Vanessa Guy-Viterbo, MD
Phone 003227649472
Email vanessa.guy@uclouvain.be
Status Recruiting
Phase Phase 4
Start date July 2013
Completion date September 2014

See also
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Recruiting NCT04792788 - NAVA vs PSV Ventilation During Weaning From Mechanical Ventilation in Children After Liver Transplantation N/A
Recruiting NCT04518332 - Intraoperative Cerebral and Renal Tissue Oxygen Saturation and Pediatric Living Donor Liver Transplantation Prognosis.
Terminated NCT02630563 - Safety, Tolerability and Pharmacokinetics of Oral CellCept (Mycophenolate Mofetil) in Pediatric Liver Transplant Recipients on Concomitant Treatment With Cyclosporine and Corticosteroids Phase 4
Recruiting NCT02957552 - Safety and Tolerance of Immunomodulating Therapy With Donor-specific MSC in Pediatric Living-Donor Liver Transplantation Phase 1
Recruiting NCT03494595 - Thromboelastometry as a Predictor of Thrombotic Complications During Pediatric Recipient Liver Transplantation
Not yet recruiting NCT05825703 - Incidence and Risk Factors of Prolonged Post-Operative Mechanical Ventilation