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
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 14, 2014
CompletedFirst Posted
Study publicly available on registry
February 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 17, 2014
February 1, 2014
11 months
February 14, 2014
February 14, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Area Under the Time Concentration curve
day 2-day 4; day 10-day 1; > day 21
Secondary Outcomes (1)
Intralymphocytic tacrolimus concentration
Day 3
Study Arms (1)
Tacrolimus
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Children aged 0 to 18 years
- First Liver transplantation
- Children eligible to receive tacrolimus post transplantation
- Consent from parents
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2014
First Posted
February 17, 2014
Study Start
July 1, 2013
Primary Completion
June 1, 2014
Study Completion
September 1, 2014
Last Updated
February 17, 2014
Record last verified: 2014-02