Identification and Characterisation of IgA With Nephritogenic Potential in IgA Deposition Nephropathies (Rep-IgAN)

NCT07295808 | Recruiting

• 1 other identifier: 87RI24_0003 - Rep-IgAN
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

IgA nephropathy (IgA Nephropathy), or Berger's disease, is the most common form of primary glomerulonephritis. It is a major cause of end-stage renal failure, often leading to dialysis or kidney transplantation. Recurrence is common after transplantation, compromising graft survival. Rheumatoid purpura (or IgA vasculitis) shares a common pathophysiology with IgA N, characterised by mesangial deposits containing IgA-rich immune complexes, but differs in its systemic involvement (skin, joints and digestive system). In terms of pathophysiology, the histological signature of these conditions is based on the accumulation of abnormal IgA within the glomerulus. The mechanisms responsible for the nephrotoxicity of these IgA remain partially unclear. In patients with NIgA, several qualitative abnormalities of IgA have been well described, including a glycosylation defect that promotes IgA polymerisation and the emergence of anti-IgA autoantibodies. These immune complexes, found in glomerular deposits, induce a local inflammatory reaction. Experimental work conducted on mouse models developed at the CRIBL laboratory has shown that these abnormalities may be linked to a dysregulation of the immune response, leading to the production of IgA with physicochemical properties that promote their deposition in the kidney. However, the location of nephritogenic IgA-secreting B cells remains poorly understood. Recent data suggest that this production could occur directly within the renal parenchyma, where activated B lymphocytes would locally produce pathogenic IgA. Following on from these observations, our study aims to characterise the immunoglobulin (Ig) repertoires in patients with IgA nephropathy, particularly those from renal lymphoid infiltrates, and to compare them with the repertoires of circulating B cells. We hypothesise that certain sequence motifs within the variable domains of IgA, particularly the CDR3 regions, could constitute specific biomarkers of NIgA. Their detection in peripheral blood could enable non-invasive or predictive diagnosis, complementing the renal biopsy that is currently essential.

Conditions

Kidney Disease

Keywords

Kidney disease; Immunoglobulin A; Berger's disease

Outcome Measures

Primary Outcomes (1)

• Variable domains of IgA

  Describe the repertoire of variable domains of IgA with nephritogenic potential in patients with IgA nephropathies

  6 months

Secondary Outcomes (1)

• Direct in situ lymphoid infiltrate mapping within the kidney

  6 months

Study Arms (1)

Blood sample taken in a Tempus tube during a blood test performed at the same time as the kidney bio

OTHER

Blood sample taken in a Tempus tube during a blood test performed at the same time as the kidney biopsy.

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

Blood sample taken in a Tempus tube during a blood test performed at the same time as the kidney biopsy.

Blood sample taken in a Tempus tube during a blood test performed at the same time as the kidney bio

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of interest: all patients with IgA nephropathy or rheumatoid purpura aged 18 years or older whose treatment requires a renal biopsy
• Control patients: all patients with a renal disease other than IgA nephropathy or rheumatoid purpura whose treatment requires a renal biopsy

You may not qualify if:

• Patient opposition
• Persons under legal guardianship
• Persons whose psychological health prevents the collection of non-opposition

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Chu Limoges

Limoges, 87042, France

RECRUITING

MeSH Terms

Conditions

Kidney Diseases; Glomerulonephritis, IGA

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glomerulonephritis; Nephritis; 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

Virginie PASCAL, Physician

CONTACT

05 55 08 71 11; virginie.pascal@chu-limoges.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 22, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): June 25, 2029
• Study Completion (Estimated): July 25, 2029
• Last Updated: December 22, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)