Prospective Tacrolimus Pharmacokinetics Study in Pediatric Living Donor Liver Transplantation

NCT ID: NCT02064777

Last Updated: 2014-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2014-09-30

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.

Conditions

Pediatric Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus

Group Type: EXPERIMENTAL

Tacrolimus

Intervention Type: DRUG

Interventions

Tacrolimus

Intervention Type: DRUG

Eligibility Criteria

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

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Vanessa Guy-Viterbo, MD

Role: CONTACT

vanessa.guy@uclouvain.be

003227649472

Raymond Reding, MD-PhD

Role: CONTACT

raymond.reding@uclouvain.be

003227641401

Other Identifiers

2012MAR19

Identifier Type: -

Identifier Source: org_study_id