Study of the IgA Repertoire During IgA Deposition Nephropathy. (ERINA)

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 Overview

• Status: Unknown
• Conditions: Glomerulonephritis, IGA
• Intervention / Treatment: Other: blood sample

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Jean-Claude ALDIGIER, MD; Phone Number: +33 5 19 56 42 74; Email: jean-claude.aldigier@unilim.fr

Study Locations

• France
  • Limoges, France, 87042
    • Recruiting
    • Service de néphrologie
    • Contact: Zhour EL OUAFI, MD; Email: zhourelouafi@yahoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with IgA nephropathy whose diagnosis was confirmed by renal biopsy

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To examine the immunoglobulins A	development of a technique for analyzing the repertoire of immunoglobulins	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: IgA nephropathy
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Kidney Diseases; Glomerulonephritis; Glomerulonephritis, IGA
• Other Study ID Numbers: 87RI19_0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No