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Pharmacokinetics of Tacrolimus in Children

NCT ID: NCT03347357

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-01

Study Completion Date

2017-09-30

Brief Summary

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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

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Conditions

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Nephrotic Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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tacrolimus

Group Type EXPERIMENTAL

Tacrolimus

Intervention Type DRUG

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

Interventions

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Tacrolimus

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Wei Zhao

Head of department of clinical pharmacy and pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Zhao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Other Identifiers

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2017TAC002

Identifier Type: -

Identifier Source: org_study_id