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

This study is currently recruiting participants.
Verified November 2012 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01775527
First received: January 18, 2013
Last updated: March 26, 2013
Last verified: November 2012
  Purpose

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 Intervention
IgA Nephropathy
Other: blood test

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • The Primary Outcome Measure of this study is the level of expression of the molecules of intestinal localization. [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcome measure is the level of expression of the homing molecules in lymphocytes B IgA memory [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
blood test Other: blood test

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775527

Locations
France
University Hospital, Limoges Recruiting
Limoges, France, 87 042
Contact: Ahmed BOUMEDIENE, MD    05 55 05 11 40    ahmed.boumediene@chu-limoges.fr   
Principal Investigator: Ahmed BOUMEDIENE, MD         
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Ahmed Boumediene, doctor University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01775527     History of Changes
Other Study ID Numbers: I10 014
Study First Received: January 18, 2013
Last Updated: March 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on April 23, 2014