Determinants of Immunosuppressive Dose Requirements in Children After Solid Organ Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01767350
Recruitment Status : Completed
First Posted : January 14, 2013
Last Update Posted : December 15, 2015
Information provided by (Responsible Party):
Noël Knops, Universitaire Ziekenhuizen Leuven

Brief Summary:

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 or disease Intervention/treatment
Transplantation Infection Procedure: Blood withdrawal for DNA

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 60 participants
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
Study Start Date : February 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Relative dose requirement of tacrolimus, ciclosporin or MMF [ Time Frame: 1 yr ]
    analysis of retrospective data concerning pharmacokinetic assessment as part of standard clinical care

Secondary Outcome Measures :
  1. Pharmacogenetic genotype [ Time Frame: 1 yr ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric recipients of a solid organ transplantation

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01767350

University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Principal Investigator: Noel Knops, MD University Hospitals Leuven


Responsible Party: Noël Knops, Dr, Universitaire Ziekenhuizen Leuven Identifier: NCT01767350     History of Changes
Other Study ID Numbers: S55088
First Posted: January 14, 2013    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015

Keywords provided by Noël Knops, Universitaire Ziekenhuizen Leuven:
Pediatric transplantation
Calcineurin inhibitors

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