CClinicalTrials.gg
CompletedNCT01609426NEPHROVIR-2Updated Mar 27, 2017

Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

An observational study in Idiopathic Nephrotic Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 6 Months to 16 Years. Per ClinicalTrials.gov, last updated 2017-03-27.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
351
Ages
6 Months to 16 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Idiopathic Nephrotic Syndrome

Keywords

  • Proteinuria
  • idiopathic
  • nephrotic syndrome
  • herpesvirus
  • epidemiology
  • immune response
  • interferon
  • steroid dependency
  • nephrotic disease: Idiopathic nephrotic syndrome
03

In context

Nephrotic Syndrome

192 studies on the registry are indexed under Nephrotic Syndrome; 63 are open to participants now.

This study's enrollment of 351 is above the median of 136 across 60 observational studies indexed under Nephrotic Syndrome.

Browse Nephrotic Syndrome studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

Exclusion Criteria:

  • patients who don't stay in Paris during the study
05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
351 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • GeneticDNA chip dedicated to the pharmacogenetic of steroids

    direct DNA extraction from peripheral blood cells

06

What researchers measure

Primary outcomes

  1. define pharmacogenetic factors of steroid dependency

    Time frame: 28.5 months

Secondary outcomes

  1. parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides

    Time frame: 28.5 months

  2. Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area

    Number of participants with idiopathic nephrotic syndrome in Paris Area to determinate if clusters cases exist.

    Time frame: 28.5 months

  3. Analysis of cortico-dependence factors

    Comparison of polymorphisms of cortico-dependent patients with non- cortico-dependent patients

    Time frame: Day 1

  4. Analysis of susceptibility factors that generate the appearance of the Idiopathic Nephrotic Syndrome

    Comparison of polymorphisms of all patients suffering from the Idiopathic Nephrotic Syndrome, with general population

    Time frame: Day 1

07

Study locations

1 site
  • APHP Robert-Debré, Department of Pediatric Nephrology
    Paris, 75020, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01609426
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jun 1, 2012
Start date
Sep 2012
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Mar 27, 2017

Study contacts

Georges Deschênes, MD-PhD
principal investigator · Assistance Publique

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion