Study of the IgA Repertoire During IgA Deposition Nephropathy.

NCT ID: NCT04092491

Last Updated: 2020-01-22

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

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-15

Study Completion Date

2021-05-31

Brief Summary

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IgA plays a major role in mucosal and systemic immunity but retains mysterious and ambivalent aspects. They can thus, depending on the situation, prove to be capable of triggering either a protective inflammatory response or, on the contrary, anti-inflammatory and inducing tolerance. Similarly, and for reasons that remain very poorly understood, they can be involved in pathologies where the immune system is itself an aggressor of the body and responsible for immunopathological lesions.

The investigator formulates the hypothesis that an inappropriate response of the mucosal immune system to one or more antigens leads to a synthesis of IgA of bad affinity favoring a deposit at the level of the mesangium. It seems important to verify this point by analyzing the IgA repertory of patients with N-IgA and comparing it to that of a control population.

Detailed Description

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IgA plays a major role in mucosal and systemic immunity but retains mysterious and ambivalent aspects. They can thus, depending on the situation, prove to be capable of triggering either a protective inflammatory response or, on the contrary, anti-inflammatory and inducing tolerance. Similarly, and for reasons that remain very poorly understood, they can be involved in pathologies where the immune system is itself an aggressor of the body and responsible for immunopathological lesions.

the investigator formulates the hypothesis that an inappropriate response of the mucosal immune system to one or more antigens leads to a synthesis of IgA of bad affinity favoring a deposit at the level of the mesangium. It seems important to verify this point by analyzing the IgA repertory of patients with N-IgA and comparing it to that of a control population.

Conditions

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Glomerulonephritis, IGA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1 blood sample

1 blood sample during a consultation carried out as part of a medical follow-up:

* 2 PAXgene RNA tubes of 2 ml each
* 1 dry tube for creatinine and IgA assay
* 1 tube of NFs (5ml)

blood sample

Intervention Type OTHER

1 blood sample during a consultation carried out as part of a medical follow-up:

* 2 PAXgene RNA tubes of 2 ml each
* 1 dry tube for creatinine and IgA assay
* 1 tube of NFs (5ml)

Interventions

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blood sample

1 blood sample during a consultation carried out as part of a medical follow-up:

* 2 PAXgene RNA tubes of 2 ml each
* 1 dry tube for creatinine and IgA assay
* 1 tube of NFs (5ml)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Control population:

* person between the ages of 18 and 55 (persons matched to age and sex (75% male) (N-IgA is more common in humans) free from any pathology.

oAbsence of proteinuria and hematuria on urine sample (search by strip).

* Patients with N-IgA

* 40 patients with N-IgA whose diagnosis was confirmed by renal biopsy. These may be previously known patients who have not received treatment with corticosteroids or immunosuppressants for 12 months or new patients. The incidence of N-IgA is 20 patients per Mh; the number of incident patients with N-IgA is 10-15 per year in the nephrology department. The recruitment of 40 patients over 1 year is feasible.
* Participant's written consent

Exclusion Criteria

* Secondary or associated N-IgA (infection, malignant disease, inflammatory bowel disease,
* Rheumatic autoimmune disease or other;
* treatment with corticosteroids or immunosuppressants for less than 12 months.
* person on dialysis
Minimum Eligible Age

18 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

Locations

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Service de Néphrologie

Limoges, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-Claude ALDIGIER, MD

Role: CONTACT

+33 5 19 56 42 74

Facility Contacts

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Zhour EL OUAFI, MD

Role: primary

Other Identifiers

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87RI19_0001

Identifier Type: -

Identifier Source: org_study_id

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