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Completed

NCT Number: NCT00577525

Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome

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.

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Key information

Conditions

Nephrosis, Lipoid Adenoviridae Infections DNA Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Kidney Diseases Male Urogenital Diseases Nephrosis Urogenital Diseases Urologic Diseases Virus Diseases

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Robert Debre

Paris, 75945, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • no medical insurance
  • inclusion in another study

Treatment and study plan

Primary outcomes

  1. Hybridization of viral genome will be studied at the first manifestation of idiopathic nephrotic syndrome

    Time frame: Within the 3 days of the first manifestation

Secondary outcomes

  1. 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.

    Time frame: 4.5 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: Nephrovir

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Dec 20, 2007
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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