Pharmacokinetics of Tacrolimus in Children

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.

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Key information

Conditions

Nephrotic Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nephrosis Urogenital Diseases Urologic Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tacrolimus

Drug

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

Primary outcomes

change of plasma concentration of Tacrolimus

Time frame: at 1,2,3,6,9,12 hours after oral administration

To detect the plasma concentrations of Tacrolimus after oral administration

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

Population Pharmacokinetics of Tacrolimus in Children With Nephrotic Syndrome

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Nov 20, 2017
Registry last updated: Nov 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed