Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis

NCT07010250 | Not Yet Recruiting

• 2 other identifiers: APHP211383PRTS-21-0009
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The project is to explore in humans the hypothesis of the link between the alteration of tubulo-interstitial metabolism and the rate of deterioration of renal function by comparing various nephropathies.

Conditions

ANCA Associated Vasculitis; Extramembranous Glomerulopathy; Nephrotic Syndrome, Minimal Change; Interstitial Nephritis; IgA Nephropathy; Segmental Hyalinosis; Diabetic Nephropathies

Keywords

nephropathy; cohort

Outcome Measures

Primary Outcomes (4)

• Spatial lipidomics for measuring tubular dysmetabolism

  Measured either through biospy at baseline or from blood and urine samples taken at baseline, after 15 days, 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up. Their contribution for classifying ANCA vasculitis and other nephropathies will be evaluated.

  Through study completion up to end of study, when the last patients completed 1 year follow-up.

• Co-staining for measuring tubular segments markers

  Measured either through biospy at baseline or from blood and urine samples taken at baseline, after 15 days, 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up. Their contribution for classifying ANCA vasculitis and other nephropathies will be evaluated.

  Through study completion up to end of study, when the last patients completed 1 year follow-up

• Immunofluorescence (at the protein level) for measuring peroxisome Proliferator-Activated Receptor-Gamma (PPAR-gamma)

  Measured either through biospy at baseline or from blood and urine samples taken at baseline, after 15 days, 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up. Its contribution for classifying ANCA vasculitis and other nephropathies will be evaluated.

  Through study completion up to end of study, when the last patients completed 1 year follow-up

• Spatial transcriptomics (at the mRNA level) for measuring peroxisome Proliferator-Activated Receptor-Gamma (PPAR-gamma)

  Measured either through biospy at baseline or from blood and urine samples taken at baseline, after 15 days, 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up. Its contribution for classifying ANCA vasculitis and other nephropathies will be evaluated.

  Through study completion up to end of study, when the last patients completed 1 year follow-up

Secondary Outcomes (16)

• Glomerular filtration rate evolution

  Through study completion up to end of study, when the last patients completed 1 year follow-up.

• Urinary protein/creatinine ratio evolution

  Through study completion up to end of study, when the last patients completed 1 year follow-up.

• Urinary albumin/creatinine evolution ratio

  Through study completion up to end of study, when the last patients completed 1 year follow-up.

• Lipidomic analysis

  Through study from baseline until one year visit.

• Metabolomic analysis

  Through study from baseline until one year visit.

Study Arms (7)

ANCA Associated Vasculitis

Case

Extramembranous Glomerulopathy

Control

Nephrotic Syndrome, Minimal Change

Control

Interstitial Nephritis

Control

IgA Nephropathy

Control

Segmental Hyalinosis

Control

Diabetic Nephropathy

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ANCA Associated Vasculitis The project is to test in humans the hypothesis of the link between the alteration of tubulo-interstitial metabolism and the rate of deterioration of renal function by comparing various nephropathies. A group of patients with ANCA vasculitis with rapidely progressive glomerulonephritis with "crescent" will be compared to six other groups : Patients with extramembranous Glomerulopathy and 2/ nephropathy with minimal glomerular lesion (LGM) by the absence of significant tubulointerstitial fibrosis lesions slow evolution towards end-stage chronic renal failure ). Other groups of patients will 3/have interstitial nephropathy, 4/IgA mesangial glomerulopathy , 5/diabetic nephropathy, or 6/collapsing focal segmental hyalinosis.

You may qualify if:

• Patients with an indication for initial diagnostic PBR on native kidney
• ans ≥ Age ≤ 90 ans
• Affiliation to french health insurance
• Patient having given consent
• For the ANCA vasculitis group:
• Diagnosis of ANCA vasculitis retained on renal biopsy with ANCA anti-proteinase 3 (PR3) or ANCA anti-myeloperoxidase (MPO)
• For the control groups:
• Diagnosis retained after the renal biopsy
• Interstitial Nephritis
• Or glomerular nephropathy such as minimal change nephropathy
• Or Segmental hyalinosis in itscollapsing form
• Or Extramembranous Glomerulopathy,
• Or glomerulopathy with mesangial IgA deposits
• Or diabetic nephropathy.

You may not qualify if:

• Kidney transplant patient
• Patient on dialysis (hemodialysis or peritoneal dialysis)
• Patient under legal protection, guardianship or curatorship
• Pregnancy or breastfeeding
• Enrollement in an interventional study except studies relating to ANCA vasculitis and nephropathy with mesangial IgA deposits.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Ministry of Health, France: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• National Research Agency, France: collaborator

Study Sites (1)

Georges-Pompidou European Hospital, AP-HP

Paris, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Additional research analyzes on the care biopsy specimen, DNA, serum and plasma biobank, urine samples for lipidomic sudies.

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Glomerulonephritis, Membranous; Nephrosis, Lipoid; Nephritis, Interstitial; Glomerulonephritis, IGA; Glomerulosclerosis, Focal Segmental; Diabetic Nephropathies; Kidney Diseases

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephrosis; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Marine LIVROZET

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maxime BRUSSIEUX

CONTACT

+33 1 44 84 17 89; maxime.brussieux@aphp.fr

Laura LE MAO

CONTACT

+33 1 56 09 54 97; laura.le-mao@aphp.fr

Study Design

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

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: June 8, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): June 2, 2029
• Study Completion (Estimated): June 2, 2029
• Last Updated: June 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (1)