Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome

NEPHROSIS, LIPOID Clinical Trial

— Nephrovir  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577525
• Other study ID #: P070126
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: February 26, 2014
• Start date: December 2007
• Est. completion date: February 2012

Study information

• Verified date: February 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: February 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 16 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Nephrosis
• Nephrosis, Lipoid
• Nephrotic Syndrome
• Virus Diseases

Locations

Country	Name	City	State
France	Hospital Robert Debre	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (14)

Debiec H, Guigonis V, Mougenot B, Haymann JP, Bensman A, Deschênes G, Ronco PM. Antenatal membranous glomerulonephritis with vascular injury induced by anti-neutral endopeptidase antibodies: toward new concepts in the pathogenesis of glomerular diseases. — View Citation

Deschênes G, Feraille E, Doucet A. [Cellular and molecular mechanisms of sodium pump activation in experimental models of nephrotic syndrome]. Nephrologie. 2003;24(3):121-6. French. — View Citation

Deschênes G, Feraille E, Doucet A. Mechanisms of oedema in nephrotic syndrome: old theories and new ideas. Nephrol Dial Transplant. 2003 Mar;18(3):454-6. — View Citation

Deschenes G. [LMXb1 generates the morphology of podocytes]. Arch Pediatr. 2002 Sep;9(9):1002-3. French. — View Citation

Doucet A, Favre G, Deschênes G. Molecular mechanism of edema formation in nephrotic syndrome: therapeutic implications. Pediatr Nephrol. 2007 Dec;22(12):1983-90. Epub 2007 Jun 7. Review. — View Citation

Féraille E, Mordasini D, Gonin S, Deschênes G, Vinciguerra M, Doucet A, Vandewalle A, Summa V, Verrey F, Martin PY. Mechanism of control of Na,K-ATPase in principal cells of the mammalian collecting duct. Ann N Y Acad Sci. 2003 Apr;986:570-8. Review. — View Citation

Frange P, Frey MA, Deschênes G. [Immunity and immunosuppression in childhood idiopathic nephrotic syndrome]. Arch Pediatr. 2005 Mar;12(3):305-15. Review. French. — View Citation

Lorton F, Raynot J, Letavernier B, Isapof A, Debiec H, Pressac M, Deschênes G, Lenoir M, Ross-Cerdan L, Grapin C, Bensman A, Ulinski T. Gross proteinuria post transplant in a child with nephrotic syndrome of the Finnish type--mechanical vs immunological p — View Citation

Lourdel S, Loffing J, Favre G, Paulais M, Nissant A, Fakitsas P, Créminon C, Féraille E, Verrey F, Teulon J, Doucet A, Deschênes G. Hyperaldosteronemia and activation of the epithelial sodium channel are not required for sodium retention in puromycin-indu — View Citation

Mansour H, Cheval L, Elalouf JM, Aude JC, Alyanakian MA, Mougenot B, Doucet A, Deschênes G. T-cell transcriptome analysis points up a thymic disorder in idiopathic nephrotic syndrome. Kidney Int. 2005 Jun;67(6):2168-77. — View Citation

Nathanson S, Cochat P, André JL, Guyot C, Loirat C, Nivet H, Deschênes G. Recurrence of nephrotic syndrome after renal transplantation: influence of increased immunosuppression. Pediatr Nephrol. 2005 Dec;20(12):1801-4. Epub 2005 Oct 14. — View Citation

Nathanson S, Lucidarme N, Landman-Parker J, Deschênes G. Long-term survival of renal graft complicated with Burkitt lymphoma. Pediatr Nephrol. 2002 Dec;17(12):1066-8. Epub 2002 Oct 8. — View Citation

Sellier-Leclerc AL, Duval A, Riveron S, Macher MA, Deschenes G, Loirat C, Verpont MC, Peuchmaur M, Ronco P, Monteiro RC, Haddad E. A humanized mouse model of idiopathic nephrotic syndrome suggests a pathogenic role for immature cells. J Am Soc Nephrol. 20 — View Citation

Ulinski T, Perrin L, Guigonis V, Driss F, Deschênes G, Bensman A. Remission of steroid- and CyA-resistant nephrotic syndrome using multiple drug immunosuppression. Pediatr Nephrol. 2007 Oct;22(10):1723-6. Epub 2007 Jul 17. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hybridization of viral genome will be studied at the first manifestation of idiopathic nephrotic syndrome		Within the 3 days of the first manifestation	No
Secondary	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	No