Pharmacokinetics of Tacrolimus in Children

November 17, 2017 updated by: Wei Zhao, Shandong University

Population Pharmacokinetics of Tacrolimus in Children With Nephrotic Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tacrolimus
Drug: Tacrolimus
Tacrolimus was administered orally at a dose of 0.05 mg/kg/dose twice daily (bid) for children with nephrotic syndrome.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 1,2,3,6,9,12 hours after oral administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Wei Zhao, Ph.D, Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

October 30, 2017

First Submitted That Met QC Criteria

November 17, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017TAC002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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