Study of the IgA Repertoire During IgA Deposition Nephropathy.

NCT04092491 | Unknown

• 1 other identifier: 87RI19_0001
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Glomerulonephritis, IGA

Keywords

IgA nephropathy

Outcome Measures

Primary Outcomes (1)

• To examine the immunoglobulins A

  development of a technique for analyzing the repertoire of immunoglobulins

  1 year

Study Arms (1)

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

Interventions

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)

1 blood sample

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with IgA nephropathy whose diagnosis was confirmed by renal biopsy

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Service de Néphrologie

Limoges, 87042, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

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)

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jean-Claude ALDIGIER, MD

CONTACT

+33 5 19 56 42 74; jean-claude.aldigier@unilim.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: September 17, 2019
• Study Start: November 15, 2019
• Primary Completion: November 1, 2020
• Study Completion: May 1, 2021
• Last Updated: January 22, 2020

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)