Back to resultsPharmacokinetics of Tacrolimus in Children
Primary Purpose
Nephrotic Syndrome
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Nephrotic Syndrome
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tacrolimus
Arm Description
Outcomes
Primary Outcome Measures
change of plasma concentration of Tacrolimus
To detect the plasma concentrations of Tacrolimus after oral administration
Secondary Outcome Measures
Full Information
NCT ID
NCT03347357
First Posted
October 30, 2017
Last Updated
November 17, 2017
Sponsor
Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT03347357
Brief Title
Pharmacokinetics of Tacrolimus in Children
Official Title
Population Pharmacokinetics of Tacrolimus in Children With Nephrotic Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2012 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
September 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tacrolimus
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Description
Tacrolimus was administered orally at a dose of 0.05 mg/kg/dose twice daily (bid) for children with nephrotic syndrome.
Primary Outcome Measure Information:
Title
change of plasma concentration of Tacrolimus
Description
To detect the plasma concentrations of Tacrolimus after oral administration
Time Frame
at 1,2,3,6,9,12 hours after oral administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhao, Ph.D
Organizational Affiliation
Shandong University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics of Tacrolimus in Children
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