Prospective Tacrolimus Pharmacokinetics Study in Pediatric Living Donor Liver Transplantation

Pediatric Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02064777
• Other study ID #: 2012MAR19
• Status: Recruiting
• Phase: Phase 4
• First received: February 14, 2014
• Last updated: February 14, 2014
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: February 2014
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Vanessa Guy-Viterbo, MD
• Phone: 003227649472
• Email: vanessa.guy[@]uclouvain.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Pediatric Liver Transplantation

Intervention

Drug:
• Tacrolimus

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Time Concentration curve		day 2-day 4; day 10-day 1; > day 21	No
Secondary	Intralymphocytic tacrolimus concentration		Day 3	No