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Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

Primary Purpose

Glomerulonephritis, IGA

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
gene transcription and cytometry
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glomerulonephritis, IGA focused on measuring IgA, kidney, Berger'disease, regulatory T cells, pathogenesis of Berger's disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nephrology Unit Hôpital Nord CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

1

2

3

Arm Description

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

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

Healthy volunteers

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 27, 2007
Last Updated
September 28, 2010
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT00521508
Brief Title
Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy
Official Title
Role of CD4+CD25+FoxP3+ Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glomerulonephritis, IGA
Keywords
IgA, kidney, Berger'disease, regulatory T cells, pathogenesis of Berger's disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Patient affected by Berger's disease confirmed by renal biopsy with increased rate of Ig A
Arm Title
2
Arm Type
Other
Arm Description
Patient affected by Berger's disease with normal rate of Ig A
Arm Title
3
Arm Type
Other
Arm Description
Healthy volunteers
Intervention Type
Procedure
Intervention Name(s)
gene transcription and cytometry
Intervention Description
samply of 30 ml of blood
Primary Outcome Measure Information:
Title
proportion averages of cells CD4+CD25+CD127 low T in peripheral blood
Time Frame
inclusion
Secondary Outcome Measure Information:
Title
average relative expression of genes FoxP3, CTLA4, GITR, IL10, TGF-B, OX40, TIM-1, and TIM-3
Time Frame
inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe MARIAT, MD PhD
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nephrology Unit Hôpital Nord CHU de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15161954
Citation
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.
Results Reference
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PubMed Identifier
16147532
Citation
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.
Results Reference
background
Citation
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
Results Reference
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Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

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