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

Nephrotic Syndrome Clinical Trial

Official title:

Guangzhou Women and Children's Medical Center

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02602873
• Other study ID #: 683292136
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 9, 2015
• Last updated: August 11, 2016
• Start date: August 2015
• Est. completion date: August 2020

Study information

• Verified date: August 2016
• Source: Guangzhou Women and Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Changzhou
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: August 2020
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 14 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Intervention

Other:
• therapeutic drug monitoring
with therapeutic drug monitoring , dose of tacrolimus can be adjusted by therapeutic drug monitoring.

Locations

Country	Name	City	State
China	Guangzhou women and children's medical center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou Women and Children's Medical Center	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Genotypes as measured by polymerase chain reaction-restriction fragment length polymorphism"	genotype are collected from hospital system.	1 week	No
Primary	"Concentration as measured by liquid chromatography mass spectrometry"	concentration of tacrolimus are collected from hospital system.	1 week	No
Primary	"Relationship between genotypes and concentration as analyzed at 1 week"	using Statistic Package for Social Science 21.0 software to analyze the relationship between gene polymorphism and concentration.	1 week	No