Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome

Completed

• Conditions: NEPHROSIS, LIPOID

• Registration Number: NCT00577525
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The primary purpose of the study is to evaluate the association of a latent infection of lymphoid cells during the first manifestation of steroid sensitive nephrite syndrome. The thirty nine units of general pediatrics and pediatric nephrite covering the parisian area will participate to the study. We speculate that hybridization of the genome, or a part of the genome, of a virus in lymphoid cells is responsible specific changes of genes expression, leading to the development of the disease.

Detailed Description

An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease and viral genome of EBV, CMV, HHV6, HHV7 as well as adenovirus will be searched for using PCR reaction in total blood DNA extract. The frequency of a latent hybridization of virus genome within human genome will be compared between patients with steroid sensitive nephrotic syndrome and controls matched for age and sex. Secondary studies will include a comparison of steroid dependency in nephrotic patients according to the occurence of a latent viral hybridization, the epidemiology of idiopathic nephrotic syndrome in the Parisian area and a pharmacogenetic analysis of steroid sensitivity and dependency. If necessary, the chromosomal localization of viral hybridization will be studied with fluorescence in situ hybridization using specific probes.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Primary Completion: 2010-07
• Study Completion: 2012-02
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 401

Inclusion Criteria

• proteinuria over 0.25 g/mmol of creatinine with hypoalbuminemia below 30g/L for the case
• No history of renal disease
• Normal C3 and negativity for hepatitis B and C

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Exclusion Criteria

• no medical insurance
• inclusion in another study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hybridization of viral genome will be studied at the first manifestation of idiopathic nephrotic syndrome	Within the 3 days of the first manifestation

Secondary Outcome Measures

Name	Time	Method
Steroid sensitivity will be checked by 1 month of prednisone therapy according to the recommendation of the " SOCIETE DE NEPROLOGIE PEDIATRIQUE" and steroid dependency will be checked at 4.5 months of prednisone therapy.	4.5 months

Trial Locations

Locations (1)

Hospital Robert Debre; 🇫🇷 Paris, France