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
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 28, 2014