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OpenTrials
Completed

NCT Number: NCT00521508

Role of 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nephrology Unit Hôpital Nord CHU de Saint-Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene transcription and cytometry

Procedure

samply of 30 ml of blood

Primary outcomes

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

    Time frame: inclusion

Secondary outcomes

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

    Time frame: inclusion

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 28, 2007
Registry last updated
Sep 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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