Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

Idiopathic Nephrotic Syndrome Clinical Trial

— NEPHROVIR-2  

Official title:

Factors of Steroid Dependency in Idiopathic Nephrotic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01609426
• Other study ID #: NI11021
• Secondary ID: AOM 11002
• Status: Completed
• Phase: N/A
• First received: April 25, 2012
• Last updated: March 24, 2017
• Start date: September 2012
• Est. completion date: June 2016

Study information

• Verified date: March 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Nephrotic Syndrome
• Nephrosis
• Nephrosis, Lipoid
• Nephrotic Syndrome
• Syndrome

Intervention

Genetic:
• DNA chip dedicated to the pharmacogenetic of steroids
direct DNA extraction from peripheral blood cells

Locations

Country	Name	City	State
France	APHP Robert-Debré, Department of Pediatric Nephrology	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	define pharmacogenetic factors of steroid dependency		28.5 months
Secondary	parameters of the immune response against herpesvirus, specially the cellular production of interferon induced by specific viral peptides		28.5 months
Secondary	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.	28.5 months
Secondary	Analysis of cortico-dependence factors	Comparison of polymorphisms of cortico-dependent patients with non- cortico-dependent patients	Day 1
Secondary	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	Day 1