Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

NCT ID: NCT01609426

Last Updated: 2017-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Idiopathic Nephrotic Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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children with idiopathic nephrotic syndrome

children below 16 years of age with a steroid dependent nephrotic syndrome

DNA chip dedicated to the pharmacogenetic of steroids

Intervention Type GENETIC

direct DNA extraction from peripheral blood cells

Interventions

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DNA chip dedicated to the pharmacogenetic of steroids

direct DNA extraction from peripheral blood cells

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

6 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Georges Deschênes, MD-PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique

Locations

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APHP Robert-Debré, Department of Pediatric Nephrology

Paris, , France

Site Status

Countries

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France

Other Identifiers

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AOM 11002

Identifier Type: OTHER

Identifier Source: secondary_id

NI11021

Identifier Type: -

Identifier Source: org_study_id

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