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Clinical Trials/NCT04092491
NCT04092491CompletedNot Applicable

Study of the IgA Repertoire During IgA Deposition Nephropathy.

University Hospital, Limoges1 site in 1 country80 target enrollmentStarted: November 15, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
To examine the immunoglobulins A

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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)

Intervention: blood sample (Other)

Outcomes

Primary Outcomes

To examine the immunoglobulins A

Time Frame: 1 year

development of a technique for analyzing the repertoire of immunoglobulins

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University Hospital, Limoges
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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