Prospective Tacrolimus Pharmacokinetics Study in Pediatric Living Donor Liver Transplantation

Phase 4

• Conditions: Pediatric Liver Transplantation
• Interventions: Drug: Tacrolimus

• Registration Number: NCT02064777
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-07
• Status Verified: 2014-02
• Study First Submitted: 2014-02-14
• Study First Submitted QC: 2014-02-14
• Last Update Submitted: 2014-02-14
• Study First Posted: 2014-02-17
• Last Update Posted: 2014-02-17
• Primary Completion: 2014-06
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
Area Under the Time Concentration curve	day 2-day 4; day 10-day 1; > day 21

Secondary Outcome Measures

Name	Time	Method
Intralymphocytic tacrolimus concentration	Day 3

Trial Locations

Locations (1)

Cliniques Universitaires St-Luc; 🇧🇪 Brussels, Belgium