Pharmacokinetics of Tacrolimus in Children

Nephrotic Syndrome Clinical Trial

Official title:

Population Pharmacokinetics of Tacrolimus in Children With Nephrotic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03347357
• Other study ID #: 2017TAC002
• Status: Completed
• Phase: Phase 4
• First received: October 30, 2017
• Last updated: November 17, 2017
• Start date: January 1, 2012
• Est. completion date: September 30, 2017

Study information

• Verified date: October 2017
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Outcome

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