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Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01609426
Acronym
NEPHROVIR-2
Enrollment
351
Registered
2012-06-01
Start date
2012-09-30
Completion date
2016-06-30
Last updated
2017-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Nephrotic Syndrome

Keywords

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

Brief 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.

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.

Interventions

GENETICDNA chip dedicated to the pharmacogenetic of steroids

direct DNA extraction from peripheral blood cells

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
6 Months to 16 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
define pharmacogenetic factors of steroid dependency28.5 months

Secondary

MeasureTime frameDescription
parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides28.5 months
Dynamic of the epidemiology of idiopathic nephrotic syndrome in the Paris Area28.5 monthsNumber of participants with idiopathic nephrotic syndrome in Paris Area to determinate if clusters cases exist.
Analysis of cortico-dependence factorsDay 1Comparison of polymorphisms of cortico-dependent patients with non- cortico-dependent patients
Analysis of susceptibility factors that generate the appearance of the Idiopathic Nephrotic SyndromeDay 1Comparison of polymorphisms of all patients suffering from the Idiopathic Nephrotic Syndrome, with general population

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026