Determinants of Immunosuppressive Dose Requirements in Children After Solid Organ Transplantation
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.
|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|
- 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
- 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
|Study Start Date:||February 2013|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01767350
|University Hospitals Leuven|
|Leuven, Belgium, 3000|
|Principal Investigator:||Noel Knops, MD||University Hospitals Leuven|