Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

Not Applicable

Completed

• Conditions: Glomerulonephritis, IGA
• Interventions: Procedure: gene transcription and cytometry

• Registration Number: NCT00521508
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-27
• Study First Submitted QC: 2007-08-27
• Study First Posted: 2007-08-28
• Study Start: 2008-04
• Primary Completion: 2010-04
• Status Verified: 2010-09
• Study Completion: 2010-09
• Last Update Submitted: 2010-09-28
• Last Update Posted: 2010-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	gene transcription and cytometry	Patient affected by Berger's disease with normal rate of Ig A
3	gene transcription and cytometry	Healthy volunteers
1	gene transcription and cytometry	Patient affected by Berger's disease confirmed by renal biopsy with increased rate of Ig A

Primary Outcome Measures

Name	Time	Method
proportion averages of cells CD4+CD25+CD127 low T in peripheral blood	inclusion

Secondary Outcome Measures

Name	Time	Method
average relative expression of genes FoxP3, CTLA4, GITR, IL10, TGF-B, OX40, TIM-1, and TIM-3	inclusion

Trial Locations

Locations (1)

Nephrology Unit Hôpital Nord CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France