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Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

This study has been completed.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00521508
First received: August 27, 2007
Last updated: September 28, 2010
Last verified: September 2010
History of Changes
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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
Study Completion Date: September 2010
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

Locations
France
Nephrology Unit Hôpital Nord CHU de Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Christophe MARIAT, MD PhD CHU Saint-Etienne
  More Information

Publications:
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: Clément CAILLAUX, CHU Saint-Etienne
ClinicalTrials.gov Identifier: NCT00521508     History of Changes
Other Study ID Numbers: 0608118, 2007-A00129-44, DGS 2007-0184
Study First Received: August 27, 2007
Last Updated: September 28, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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
Glomerulonephritis, IGA
Kidney Diseases
Nephritis
 Urologic Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013