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Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

NCT ID: NCT00521508

Last Updated: 2010-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Glomerulonephritis, IGA

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Patient affected by Berger's disease confirmed by renal biopsy with increased rate of Ig A

Group Type OTHER

gene transcription and cytometry

Intervention Type PROCEDURE

samply of 30 ml of blood

2

Patient affected by Berger's disease with normal rate of Ig A

Group Type OTHER

gene transcription and cytometry

Intervention Type PROCEDURE

samply of 30 ml of blood

3

Healthy volunteers

Group Type OTHER

gene transcription and cytometry

Intervention Type PROCEDURE

samply of 30 ml of blood

Interventions

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gene transcription and cytometry

samply of 30 ml of blood

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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CHU Saint-Etienne

Principal Investigators

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Christophe MARIAT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Nephrology Unit Hôpital Nord CHU de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

References

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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. doi: 10.1093/ndt/gfh309. Epub 2004 May 25. No abstract available.

Reference Type BACKGROUND
PMID: 15161954 (View on PubMed)

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. doi: 10.1098/rstb.2005.1706.

Reference Type BACKGROUND
PMID: 16147532 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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2007-A00129-44

Identifier Type: -

Identifier Source: secondary_id

DGS 2007-0184

Identifier Type: -

Identifier Source: secondary_id

0608118

Identifier Type: -

Identifier Source: org_study_id