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Completed

NCT Number: NCT01775527

IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

IgA nephropathy (IgAN) is the most common primary glomerulonephritis in the world and it represents an important cause of end-stage kidney failure. This disease was described as a distinct entity in 1968 by J Berger and N Hinglais. The aetiology and the pathogenesis remain still obscure. Clinical observations and immunisation studies indicate that IgAN represents a dysregulation of the immune system, rather than an intrinsic renal abnormality. Twenty years ago, some authors proposed the mucosa-bone marrow axis to explain the pathogenesis of the disease. Mucosal IgA plasmocytes are displaced and take up residence in systemic sites. The unusual characteristics featured by the IgA produced by these cells (charge, size, glycosylation) drive their accumulation, deposition and mesangial activation characteristic of IgAN.

Evidence is emerging that altered lymphocyte homing may ultimately explain this aberrant localization.

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Key information

Conditions

IgA Nephropathy Autoimmune Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Limoges

Limoges, 87 042, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18 and < 70 years
  • IgA nephropathy documented by the kidney biopsy in the six months preceding the inclusion
  • Glomerular filtration rate (MDRD formula as simplified) < 90 ml/mn and > 30 ml/mn/1,73 m2
  • Consent form signed

Exclusion criteria

  • Patients with cirrhosis or chronic liver disease
  • Patients with a history of Crohn's disease or celiac disease
  • Patients who received treatment with corticosteroids or affiliates for six months
  • Patients who received a live attenuated vaccine during the past 4 weeks
  • Patients with a known infection such as HIV, hepatitis B or C
  • Patients who presented with a serious infection during the last month
  • Breastfeeding women
  • Patients not affiliated with a social security scheme
  • Under guardianship patient

Treatment and study plan

Blood Test

Other

Primary outcomes

  1. The Primary Outcome Measure of this study is the level of expression of the molecules of intestinal localization.

    Time frame: 30 minutes

Secondary outcomes

  1. The secondary outcome measure is the level of expression of the homing molecules in lymphocytes B IgA memory

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: NIDOCIGA

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Jan 25, 2013
Registry last updated
Aug 22, 2016

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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