Pharmacokinetics of Tacrolimus in Children

Population Pharmacokinetics of Tacrolimus in Children With Nephrotic Syndrome

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03347357

Enrollment

Registered

2017-11-20

Start date

2012-01-01

Completion date

2017-09-30

Last updated

2017-11-20

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

Conditions

Nephrotic Syndrome

Brief summary

the present study was conducted to assess the population pharmacokinetics of tacrolimus in children with nephrotic syndrome and to use these data to calculate an optimal dosing regimen of tacrolimus for use in these patients.

Interventions

DRUGTacrolimus

Tacrolimus was administered orally at a dose of 0.05 mg/kg/dose twice daily (bid) for children with nephrotic syndrome.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 18 Years

Healthy volunteers

Inclusion criteria

* patients have been diagnosed with nephrotic syndrome; * age range: 1 month to 18 years old * tacrolimus used as part of regular treatment

Exclusion criteria

* expected survival time less than the treatment cycle; * patients with other factors that researcher considers unsuitable for inclusion.

Design outcomes

Primary

Measure	Time frame	Description
change of plasma concentration of Tacrolimus	at 1,2,3,6,9,12 hours after oral administration	To detect the plasma concentrations of Tacrolimus after oral administration

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026