NCT04092491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2025

Completed
Last Updated

June 24, 2026

Status Verified

June 1, 2026

Enrollment Period

6 years

First QC Date

August 8, 2019

Last Update Submit

June 23, 2026

Conditions

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

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Néphrologie

Limoges, 87042, France

Location

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)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

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 26, 2025

Study Completion

November 26, 2025

Last Updated

June 24, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations