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Clinical Trials/NCT01775527
NCT01775527CompletedNot Applicable

IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

University Hospital, Limoges2 sites in 1 country72 target enrollmentStarted: February 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
72
Locations
2
Primary Endpoint
The Primary Outcome Measure of this study is the level of expression of the molecules of intestinal localization.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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

Time Frame: 30 minutes

Secondary Outcomes

  • The secondary outcome measure is the level of expression of the homing molecules in lymphocytes B IgA memory(30 minutes)

Investigators

Sponsor
University Hospital, Limoges
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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