Development of a dosingprogram for tacrolimus in children

The PedTac study Development of a pediatric pharmacokinetic population model for Tacrolimus - PedTac

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000793-30-NO

Enrollment

140

Registered

2013-07-29

Start date

2013-10-22

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid organ transplantation MedDRA version: 16.0 Level: HLT Classification code 10052779 Term: Transplant rejections System Organ Class: 100000004870 MedDRA version: 16.0 Level: HLT Classification code 10043411 Term: Therapeutic drug monitoring analyses System Organ Class: 100000004848

Interventions

Trade Name: Advagraf Pharmaceutical Form: Modified-release capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987-11-3 Concentration unit: mg milligram(s) Concentration type: up to Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Pediatric patients 0 – 18 years of age • Solid organ transplant recipients • Patients treated with tacrolimus as part of their immunosuppressive therapy • Signed informed consent, either signed by the patient or for children below the age of 16, by next of kin Are the trial subjects under 18? yes Number of subjects for this age range: 140 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Drugs known to interact with tacrolimus and not usually used in solid organ transplantation

Design outcomes

Primary

Measure	Time frame
Main Objective: Develop and validate a population pharmacokinetic model for tacrolimus for the use as a dosing tool in solid organ transplanted children of different age groups;Secondary Objective: NA;Primary end point(s): External validation of the model with estimation of the predictive error.;Timepoint(s) of evaluation of this end point: Endpoints are for the model validation. Time points for collection of blood samples are at any scheduled follow-up visit after transplantation.	—

Measure

Time frame

Main Objective: Develop and validate a population pharmacokinetic model for tacrolimus for the use as a dosing tool in solid organ transplanted children of different age groups;Secondary Objective: NA;Primary end point(s): External validation of the model with estimation of the predictive error.;Timepoint(s) of evaluation of this end point: Endpoints are for the model validation. Time points for collection of blood samples are at any scheduled follow-up visit after transplantation.

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Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Norway

Contacts

Public ContactAnna Bjerre

Oslo University Hospital-Rikshospitalet

anna.bjerre@ous-hf.no47230700004596

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026