Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome (NEPHROVIR-2)

March 24, 2017 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

351

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

  • France
      • Paris, France, 75020
        • APHP Robert-Debré, Department of Pediatric Nephrology

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

6 months to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any children below 16 years of age with a first manifestation of idiopathic nephrotic syndrome commencing or having commenced in the Paris area

Description

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

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?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
children with idiopathic nephrotic syndrome
children below 16 years of age with a steroid dependent nephrotic syndrome
Genetic: DNA chip dedicated to the pharmacogenetic of steroids
direct DNA extraction from peripheral blood cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
define pharmacogenetic factors of steroid dependency
Time Frame: 28.5 months
28.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides
Time Frame: 28.5 months
28.5 months
Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area
Time Frame: 28.5 months
Number of participants with idiopathic nephrotic syndrome in Paris Area to determinate if clusters cases exist.
28.5 months
Analysis of cortico-dependence factors
Time Frame: Day 1
Comparison of polymorphisms of cortico-dependent patients with non- cortico-dependent patients
Day 1
Analysis of susceptibility factors that generate the appearance of the Idiopathic Nephrotic Syndrome
Time Frame: Day 1
Comparison of polymorphisms of all patients suffering from the Idiopathic Nephrotic Syndrome, with general population
Day 1

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Georges Deschênes, MD-PhD, Assistance Publique

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 (Actual)

September 1, 2012

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

April 25, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (Estimate)

June 1, 2012

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI11021
  • AOM 11002 (Other Identifier: Assistance Publique)

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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