Overview

This trial is active, not recruiting.

Condition idiopathic nephrotic syndrome
Treatment dna chip dedicated to the pharmacogenetic of steroids
Sponsor Assistance Publique - Hôpitaux de Paris
Start date September 2012
End date June 2016
Trial size 351 participants
Trial identifier NCT01609426, AOM 11002, NI11021

Summary

The primary purpose of the study is to identify the factors of steroid dependency in childhood idiopathic nephrotic syndrome. The steroid dependency is defined by a relapse of nephrotic syndrome within the 3 weeks that follow the withdrawal of steroid therapy after the first manifestation. Different clinical and biological factors will be analyzed: age of first manifestation, delay of remission, ethnicity, and preceding viral infection, geolocalization in the Parisian area, genoprevalence of herpes viruses and polymorphisms in the genes involved in the response to steroid therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Arm
children below 16 years of age with a steroid dependent nephrotic syndrome
dna chip dedicated to the pharmacogenetic of steroids
direct DNA extraction from peripheral blood cells

Primary Outcomes

Measure
define pharmacogenetic factors of steroid dependency
time frame: 28.5 months

Secondary Outcomes

Measure
parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides
time frame: 28.5 months
Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area
time frame: 28.5 months
Analysis of cortico-dependence factors
time frame: Day 1
Analysis of susceptibility factors that generate the appearance of the Idiopathic Nephrotic Syndrome
time frame: Day 1

Eligibility Criteria

Male or female participants from 6 months up to 16 years old.

Inclusion Criteria: - children below 16 years - first manifestation of nephrotic syndrome - steroid sensitivity according to the recommendations of the french "pediatric society nephrology" Exclusion Criteria: - patients who don't stay in Paris during the study

Additional Information

Official title Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome
Principal investigator Georges Deschênes, MD-PhD
Description Patients with a steroid dependent nephrotic syndrome will be compared to those with a non steroid dependent form of nephrotic syndrome at the end of the first manifestation. An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease. Genetics factors will be checked using a DNA chips devoted to the response to steroid therapy and viral genome of EBV, CMV, HHV7 will be searched for using PCR reaction in total blood DNA extract.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.