Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

NCT00521508 | Completed

• 3 other identifiers: 06081182007-A00129-44DGS 2007-0184
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glomerulonephritis, IGA

Keywords

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

Outcome Measures

Primary Outcomes (1)

• proportion averages of cells CD4+CD25+CD127 low T in peripheral blood

  inclusion

Secondary Outcomes (1)

• average relative expression of genes FoxP3, CTLA4, GITR, IL10, TGF-B, OX40, TIM-1, and TIM-3

  inclusion

Study Arms (3)

1

OTHER

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

Procedure: gene transcription and cytometry

2

OTHER

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

Procedure: gene transcription and cytometry

3

OTHER

Healthy volunteers

Procedure: gene transcription and cytometry

Interventions

gene transcription and cytometry PROCEDURE

samply of 30 ml of blood

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• C-reactive protein (CRP) \> 10 mgL-1

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Nephrology Unit Hôpital Nord CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (3)

• 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.

  PMID: 15161954 BACKGROUND

• 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.

  PMID: 16147532 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Transcription, Genetic

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biochemical Phenomena; Chemical Phenomena; Gene Expression; Genetic Phenomena

Study Officials

• Christophe MARIAT, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 28, 2007
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 29, 2010

Record last verified: 2010-09

Locations

FR (1)