Role of Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

September 28, 2010 updated by: Centre Hospitalier Universitaire de Saint Etienne

Role of CD4+CD25+FoxP3+ Regulatory T Cells in Pathogenesis of Primary IgA Nephropathy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • Nephrology Unit Hôpital Nord CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 2
Patient affected by Berger's disease with normal rate of Ig A
Procedure: gene transcription and cytometry
samply of 30 ml of blood
Other: 3
Healthy volunteers
Procedure: gene transcription and cytometry
samply of 30 ml of blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
proportion averages of cells CD4+CD25+CD127 low T in peripheral blood
Time Frame: inclusion
inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
average relative expression of genes FoxP3, CTLA4, GITR, IL10, TGF-B, OX40, TIM-1, and TIM-3
Time Frame: inclusion
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 27, 2007

First Submitted That Met QC Criteria

August 27, 2007

First Posted (Estimate)

August 28, 2007

Study Record Updates

Last Update Posted (Estimate)

September 29, 2010

Last Update Submitted That Met QC Criteria

September 28, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0608118
  • 2007-A00129-44
  • DGS 2007-0184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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