IgA Nephropathy, Lymphocyte Homing and IgA Class Switch

NCT ID: NCT01775527

Last Updated: 2016-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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IgA Nephropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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blood test

Group Type OTHER

blood test

Intervention Type OTHER

Interventions

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blood test

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Limoges

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed Boumediene, doctor

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

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University Hospital, Limoges

Limoges, , France

Site Status

Countries

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France

Other Identifiers

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I10 014

Identifier Type: -

Identifier Source: org_study_id

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