Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

This study is currently recruiting participants.

Verified by Centre Hospitalier Universitaire de Saint Etienne, June 2009

First Received: August 27, 2007 Last Updated: June 8, 2009 History of Changes

Sponsor:	Centre Hospitalier Universitaire de Saint Etienne
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00521508

Purpose

Along structural IgA abnormalities, hyperproduction of IgA is thought to play a role in the pathogenesis of primary IgA nephropathy. CD4+CD25+Fox3P regulatory T cells are instrumental in suppressing adaptative immune responses, including B cells production of immunoglobulins. We, the researchers at Centre Hospitalier Universitaire de Saine Etienne, will test the hypothesis that IgA production in patients with IgA nephropathy is dysregulated because of a quantitative and/or qualitative defect of CD4+CD25+FoxP3+ regulatory T cells.

Condition	Intervention
Glomerulonephritis, IGA	Procedure: gene transcription and cytometry

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Role of CD4+CD25+FoxP3+ Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:

proportion averages of cells CD4+CD25+CD127 low T in peripheral blood [ Time Frame: inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

average relative expression of genes FoxP3, CTLA4, GITR, IL10, TGF-B, OX40, TIM-1, and TIM-3 [ Time Frame: inclusion ] [ Designated as safety issue: No ]

Estimated Enrollment:	45
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Patient affected by Berger's disease confirmed by renal biopsy with increased rate of Ig A	Procedure: gene transcription and cytometry samply of 30 ml of blood
2 Patient affected by Berger's disease with normal rate of Ig A	Procedure: gene transcription and cytometry samply of 30 ml of blood
3 Healthy volunteers	Procedure: gene transcription and cytometry samply of 30 ml of blood

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patients with pathogenesis of Berger's disease confirmed by renal biopsy
Glomerular filtration > 60 ml/min/1,73m2
Written informed consent
Patient affiliated to social insurance

Exclusion Criteria:

Immunosuppressor treatment within 6 months before the study inclusion
Clinical infection within 2 months before the study inclusion
C-reactive protein (CRP) > 10 mgL-1

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521508

Contacts

Contact: Christophe MARIAT, MD PhD	+33(0)477828380	Christophe.Mariat@@univ-st-etienne.fr
Contact: Carine LABRUYERE, CRA	+33(0)477120469	carine.labruyere@chu-st-etienne.fr

Locations

France
Nephrology Unit Hôpital Nord CHU de Saint-Etienne	Recruiting
Saint-Etienne, France, 42055
Contact: Christophe MARIAT, MD PhD 0033477828380 Christophe.Mariat@univ-st-etienne.fr
Sub-Investigator: François BERTHOUX, MD PhD
Sub-Investigator: Eric ALAMARTINE, MD PhD
Sub-Investigator: Damien THIBAUDIN, MD PhD
Sub-Investigator: Jean-Pierre de FILIPPIS, MD PhD
Sub-Investigator: Manolie PHAYPHET, MD PhD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator:

Christophe MARIAT, MD PhD

CHU Saint-Etienne

More Information

Publications:

Laville M, Alamartine E. Treatment options for IgA nephropathy in adults: a proposal for evidence-based strategy. Nephrol Dial Transplant. 2004 Aug;19(8):1947-51. Epub 2004 May 25. No abstract available.

Mariat C, Sanchez-Fueyo A, Alexopoulos SP, Kenny J, Strom TB, Zheng XX. Regulation of T cell dependent immune responses by TIM family members. Philos Trans R Soc Lond B Biol Sci. 2005 Sep 29;360(1461):1681-5. Review.

Mariat C Degauque N et al. TIM-1 strengthens Th-1 polarization and weakens CD4+CD25 T cells. Am J Transplant 6(suppl 2): 557, 2006

Responsible Party:	CHU Saint-Etienne ( Clément CAILLAUX )
Study ID Numbers:	0608118, 2007-A00129-44, DGS 2007-0184
Study First Received:	August 27, 2007
Last Updated:	June 8, 2009
ClinicalTrials.gov Identifier:	NCT00521508 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

IgA
kidney
Berger'disease
regulatory T cells
pathogenesis of Berger's disease

Additional relevant MeSH terms:

Glomerulonephritis
Autoimmune Diseases
Immune System Diseases
Urologic Diseases

Nephritis
Glomerulonephritis, IGA
Kidney Diseases

ClinicalTrials.gov processed this record on February 08, 2010