Study of Tacrolimus Used for Pediatric Patients With Nephrotic Syndrome Based on Pharmacogenomics and Metabonomics

August 11, 2016 updated by: Mo Xiaolan, Guangzhou Women and Children's Medical Center

Guangzhou Women and Children's Medical Center

Tacrolimus is recommended to be the first line therapeutic medication within the several immunosuppressive agents when treating refractory pediatric nephrotic syndrome, because of its definite efficacy and low toxicity. But there are still some key problems which hinder the using of tacrolimus in clinic, such as its narrow therapeutic widow, great individual difference of pharmacokinetics. Routine therapeutic drug monitoring(TDM) is needed in practice. But the disadvantage of TDM is hysteresis, which could lead to treatment failure or toxicity. To find out the reasons of great pharmacokinetic difference between patients and find out the individual proper dosage before administration are important for the clinical using of tacrolimus.

It is hot in research of tacrolimus in organ transplant field, such as the association between gene polymorphisms of cytochrome P-450 3A4, 3A5 and multiple drug resistant gene(MDR1) and concentration of tacrolimus. However, there is few study about pharmacogenomics and metabonomics of tacrolimus in patients of nephrotic syndrome.

The aim is to study the relationships between pharmacogenomics, metabonomics of tacrolimus and its efficacy, toxicity and blood concentration in patients of nephrotic syndrome, to find out the exact dosage before administration, to provide reference to individual drug administration.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Investigators will collect data about efficacy and adverse drug reaction(ADR) such as time of efficacy when evaluated, how to evaluate ADR, data of demography, etc.

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510623
        • Guangzhou Women and Children's Medical Center

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 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

pediatric patients with nephrotic syndrome

Description

Inclusion Criteria:

  1. patients with refractory nephrotic syndrome;
  2. patients age ≤14y.

Exclusion Criteria:

  1. patients are sensitive to steroid;
  2. combined therapy with other immunosuppressive agent;
  3. combined using drugs which maybe interact the concentration of tacrolimus;
  4. with other malignant disease, such as tumor.

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?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
good efficacy
using therapeutic drug monitoring to adjust the dose of tacrolimus. patients can reach effective outcome.
Other: therapeutic drug monitoring
with therapeutic drug monitoring , dose of tacrolimus can be adjusted by therapeutic drug monitoring.
poor efficacy
using therapeutic drug monitoring to adjust the dose of tacrolimus. patients can not reach effective outcome.
Other: therapeutic drug monitoring
with therapeutic drug monitoring , dose of tacrolimus can be adjusted by therapeutic drug monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism"
Time Frame: 1 week
genotype are collected from hospital system.
1 week
"Concentration as measured by liquid chromatography mass spectrometry"
Time Frame: 1 week
concentration of tacrolimus are collected from hospital system.
1 week
"Relationship between genotypes and concentration as analyzed at 1 week"
Time Frame: 1 week
using Statistic Package for Social Science 21.0 software to analyze the relationship between gene polymorphism and concentration.
1 week

Collaborators and Investigators

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

Sponsor

Guangzhou Women and Children's Medical Center

Collaborators

Sun Yat-sen University

Investigators

  • Study Director: Min Huang, Doctor, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

November 10, 2015

First Posted (Estimate)

November 11, 2015

Study Record Updates

Last Update Posted (Estimate)

August 12, 2016

Last Update Submitted That Met QC Criteria

August 11, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 683292136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

we are carrying out experiment now. Data is not ready to publish for not completing the study. We will share data when we complete our study.

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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