NCT02329808

Brief Summary

This is a clincial validation study of a dried blood spot (DBS) method for the analysis of immunosuppressive and antifungal agents currently subject of therapeutic drug monitoring (TDM) in a pediatric population. The primary goal is to clinically validate a finger prick DBS method compared to conventional venous sampling for the analysis of 5 immunosuppressive and 4 azole antifungal drugs in the pediatric population. Secondairy goals include feasibility of the finger prick DBS method in the target population, to design an inventory of costs that will be incurred in future health-economic analyses and to construct a population PK model based on the available data collected for the primariy goal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2021

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

6.5 years

First QC Date

December 19, 2014

Last Update Submit

May 9, 2022

Conditions

Hematologic DiseasesOncology ProblemKidney DiseasesTransplantation Infection

Keywords

TDMdried blood spotimmunosuppressiveantifungal

Outcome Measures

Primary Outcomes (1)

  • drug concentration

    The outcome measure is a composite of several blood concentrations, obtained by three individual blood drawing moments per patient. The related endpoint is the evaluation of the association between the concentration obtained by venous sampling and the concentration obtained by means of DBS sampling. The predictive performance of the DBS method as a measure for the venous concentration will be evaluated.

    predose, 2 samples postdose, max 6 hours post dose

Secondary Outcomes (3)

  • Questionnaire

    1 day

  • costs

    2 years

  • Area under the curve

    6h period

Study Arms (9)

Mycophenolic acid

Patients treated for their regular patient care with mycophenolic acid.

Procedure: blood drawing

Cyclosporin

Patients treated for their regular patient care with cyclosporin.

Procedure: blood drawing

Tacrolimus

Patients treated for their regular patient care with tacrolimus.

Procedure: blood drawing

Sirolimus

Patients treated for their regular patient care with sirolimus.

Procedure: blood drawing

Everolimus

Patients treated for their regular patient care with everolimus.

Procedure: blood drawing

Voriconazole

Patients treated for their regular patient care with voriconazole.

Procedure: blood drawing

Posaconazole

Patients treated for their regular patient care with posaconazole.

Procedure: blood drawing

Itraconazole+metabolite

Patients treated for their regular patient care with itraconazole.

Procedure: blood drawing

Fluconazole

Patients treated for their regular patient care with fluconazole.

Procedure: blood drawing

Interventions

blood drawingPROCEDURE

The association between conventional venous sampling and finger prick dried blood spot (DBS) will be associated by drawing blood in both ways.

CyclosporinEverolimusFluconazoleItraconazole+metaboliteMycophenolic acidPosaconazoleSirolimusTacrolimusVoriconazole

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Pediatric hemato-oncology and primariy immunodeficient patients and pediatric renal transplantation patients.

You may qualify if:

  • Patients aged between 2 and 18 years
  • Admitted to the Radboudumc pediatric ward
  • Having a venous catheter
  • Treated with at least 1 of the 9 drugs of interest
  • The drug concentration being at steady state
  • Signed informed consent

You may not qualify if:

  • Parents and/or patients are not able to understand the Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma without DNA, blood with DNA and dried blood spot (with DNA)

MeSH Terms

Conditions

Hematologic DiseasesKidney Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Roger Bruggemann, PharmD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2014

First Posted

January 1, 2015

Study Start

June 1, 2015

Primary Completion

December 3, 2021

Study Completion

December 3, 2021

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)