Clinical trial NCT07010250: Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis
Official title: Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ANCA Associated Vasculitis
Extramembranous Glomerulopathy
Nephrotic Syndrome, Minimal Change
Interstitial Nephritis
IgA Nephropathy
Segmental Hyalinosis
Diabetic Nephropathies
Keywords: nephropathy
cohort
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: Institut National de la Santé Et de la Recherche Médicale, France
name: National Research Agency, France
First posted: 2025-06-08
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Patients with ANCA vasculitis with rapidly progressive glomerulonephritis with "crescent" will be compared to six other groups made up of patients with another nephropathy 1/extramembranous glomerulonephritis and 2/ nephropathy with minimal glomerular lesion (LGM) characterized by the absence of significant tubulointerstitial fibrosis lesions and 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.

Eligibility criteria: Inclusion Criteria:

* Patients with an indication for initial diagnostic PBR on native kidney
* 18 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Spatial lipidomics for measuring tubular dysmetabolism
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
measure: Co-staining for measuring tubular segments markers
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up
measure: Immunofluorescence (at the protein level) for measuring peroxisome Proliferator-Activated Receptor-Gamma (PPAR-gamma)
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up
measure: Spatial transcriptomics (at the mRNA level) for measuring peroxisome Proliferator-Activated Receptor-Gamma (PPAR-gamma)
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up
Secondary outcomes:
measure: Glomerular filtration rate evolution
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
measure: Urinary protein/creatinine ratio evolution
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
measure: Urinary albumin/creatinine evolution ratio
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
measure: Lipidomic analysis
timeFrame: Through study from baseline until one year visit.
measure: Metabolomic analysis
timeFrame: Through study from baseline until one year visit.
measure: Proportion of fibrotic tissues
timeFrame: At baseline.
measure: Capillary density
timeFrame: At baseline.
measure: Markers of podocytes, renal epithelial cells and specific leukocyte populations
timeFrame: At baseline.
measure: Quantification of fibrosis
timeFrame: At baseline.
measure: IMC (imaging mass cytometry)
timeFrame: At baseline.
measure: Transcriptomic analysis
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
measure: Diastole
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
measure: Systole
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
measure: Heart rate
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
measure: Blood count analysis
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
measure: Leukocytes evolution
timeFrame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Other outcomes:
Locations:
city: Paris
country: France
facility: Georges-Pompidou European Hospital, AP-HP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marine LIVROZET
role: PRINCIPAL_INVESTIGATOR
References: