Pharmacokinetics of Tacrolimus in Children

Phase 4

Completed

• Conditions: Nephrotic Syndrome
• Interventions: Drug: Tacrolimus

• Registration Number: NCT03347357
• Lead Sponsor: Shandong University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-01
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Status Verified: 2017-10
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-11-17
• Last Update Submitted: 2017-11-17
• Study First Posted: 2017-11-20
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tacrolimus	Tacrolimus	-

Primary Outcome Measures

Name	Time	Method
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