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OpenTrials
Completed

NCT Number: NCT04092491

Study of the IgA Repertoire During IgA Deposition Nephropathy.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Néphrologie

Limoges, 87042, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood sample

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)

Primary outcomes

  1. To examine the immunoglobulins A

    Time frame: 1 year

    development of a technique for analyzing the repertoire of immunoglobulins

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: ERINA

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 17, 2019
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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