Nephrovir: Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00577525

Collaborator

(none)

401

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
NEPHROSIS, LIPOID

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 Design

Study Type:

Observational

Actual Enrollment :

401 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Viral Infection of Lymphoid Cells Occuring at the First Manifestation of Idiopathic Nephrotic Syndrome

Study Start Date :

Dec 1, 2007

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
1 Case : Patients with steroid sensitive nephrotic syndrome
2 Controls (matched for age and sexe with the first group)

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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