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IgA Nephropathy, Lymphocyte Homing and IgA Class Switch (NIDOCIGA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01775527
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : August 22, 2016
Information provided by (Responsible Party):
University Hospital, Limoges

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
IgA Nephropathy Other: blood test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: IgA Nephropathy, Lymphocyte Homing and IgA Class Switch
Study Start Date : February 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
blood test Other: blood test

Primary Outcome Measures :
  1. The Primary Outcome Measure of this study is the level of expression of the molecules of intestinal localization. [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. The secondary outcome measure is the level of expression of the homing molecules in lymphocytes B IgA memory [ Time Frame: 30 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01775527

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University Hospital, Limoges
Limoges, France, 87 042
Sponsors and Collaborators
University Hospital, Limoges
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Principal Investigator: Ahmed Boumediene, doctor University Hospital, Limoges

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Responsible Party: University Hospital, Limoges Identifier: NCT01775527     History of Changes
Other Study ID Numbers: I10 014
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: November 2012

Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Autoimmune Diseases
Immune System Diseases