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Recruiting NCT07010250

Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis

— Observational ANCA Associated Vasculitis Extramembranous Glomerulopathy Nephrotic Syndrome, Minimal Change Interstitial Nephritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: ANCA Associated Vasculitis, Extramembranous Glomerulopathy, Nephrotic Syndrome, Minimal Change, Interstitial Nephritis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Spatial lipidomics for measuring tubular dysmetabolism [Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up.]
  • Co-staining for measuring tubular segments markers [Time frame: 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) [Time frame: 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) [Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up]
Secondary outcome measures (12)
  • Glomerular filtration rate evolution [Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up.]
  • Urinary protein/creatinine ratio evolution [Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up.]
  • Urinary albumin/creatinine evolution ratio [Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up.]
  • Lipidomic analysis [Time frame: Through study from baseline until one year visit.]
  • Metabolomic analysis [Time frame: Through study from baseline until one year visit.]
  • Proportion of fibrotic tissues [Time frame: At baseline.]
  • Capillary density [Time frame: At baseline.]
  • Markers of podocytes, renal epithelial cells and specific leukocyte populations [Time frame: At baseline.]
  • Quantification of fibrosis [Time frame: At baseline.]
  • IMC (imaging mass cytometry) [Time frame: At baseline.]
  • Transcriptomic analysis [Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up.]
  • Diastole [Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Georges-Pompidou European Hospital, AP-HP — Paris

Identifiers

NCT: NCT07010250 · APHP211383 · PRTS-21-0009

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗