Determinants of Immunosuppressive Dose Requirements in Children After Solid Organ Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Noël Knops, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01767350
First received: January 10, 2013
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

The long-term success of solid organ transplantation is largely dependent on the efficacy of immunosuppressive medication. Unfortunately, for the most important agents the correct drug levels are difficult to attain, with potential severe consequences of drug under- or overexposure. In addition there is a large variation in dose requirements within and between different subjects. Clinical studies have demonstrated that a better control of drug exposure can improve outcome. A large set of patient characteristics appear important in determining dose requirements in adults, in particular genetic variation in genes involved in drug metabolism. In children relative dose requirements are increased compared to adults, but is not known why and the role of pharmacogenetic variation has not been described.

Our study aims to describe relative dose requirements in children after solid organ transplantation with the help of clinical and laboratory data obtained during regular hospital visits (retrospective). In addition we will assess their genotype for genes involved in the metabolism of immunosuppressives.


Condition Intervention
Transplantation Infection
Procedure: Blood withdrawal for DNA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Study Aimed at Determining the Relation Between the Administered Dose and Exposure to Immunosuppressive Medication in Children After Solid Organ Transplantation

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Relative dose requirement of tacrolimus, ciclosporin or MMF [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
    analysis of retrospective data concerning pharmacokinetic assessment as part of standard clinical care


Secondary Outcome Measures:
  • Pharmacogenetic genotype [ Time Frame: 1 yr ] [ Designated as safety issue: No ]
    Analysis of DNA obtained during a regular hospital visit for genetic variants relevant for metabolism of immunosuppression according to literature (CYP3A4, CYP3A5, MDR1, etc)


Biospecimen Retention:   Samples With DNA

tube of whole blood (8 ml) to be processed for DNA extraction and storage


Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
children with organ transplant
Subjects who received an solid organ transplant at our institution at the age of 0-19 yrs and who were subject to pharmacokinetic evaluation during their follow up. Additional blood withdrawal for DNA will be performed
Procedure: Blood withdrawal for DNA
Single withdrawal of 8 ml whole blood for DNA analysis, during a "standard" blood collection as part of standard clinical follow up.
Other Name: not applicalble

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric recipients of a solid organ transplantation

Criteria

Inclusion Criteria:

  • All pediatric recipients of a solid organ transplantation in our hospital
  • Extensive pharmacokinetic study of immunosuppression (AUC) performed during follow up
  • Consent of child/caretaker

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01767350

Contacts
Contact: Noel Knops, MD +32 16 343827 noelknops@uzleuven.be
Contact: Mieke van Dyck, MD +32 16 343827 maria.vandyck@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Noel Knops, MD    +32 16 343827    noelknops@uzleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Noel Knops, MD University Hospitals Leuven
  More Information

Publications:

Responsible Party: Noël Knops, Dr, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01767350     History of Changes
Other Study ID Numbers: S55088
Study First Received: January 10, 2013
Last Updated: April 11, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Pediatric transplantation
Pharmacogenetics
Pharmacokinetics
Calcineurin inhibitors
CYP3A
Pgp

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014