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NCT Number: NCT07010250

Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis

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.

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Key information

Conditions

ANCA Associated Vasculitis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Extramembranous Glomerulopathy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Glomerulonephritis, Membranous Glomerulosclerosis, Focal Segmental IgA Nephropathy Immune System Diseases Interstitial Nephritis Kidney Diseases Male Urogenital Diseases Nephritis Nephritis, Interstitial Nephrosis Nephrosis, Lipoid Nephrotic Syndrome, Minimal Change Segmental Hyalinosis Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Urogenital Diseases Urologic Diseases Vascular Diseases Vasculitis

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Georges-Pompidou European Hospital, AP-HP

Paris, France

Location status: Recruiting

Location contact

Marine Livrozet

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    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.

  2. 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

    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.

  3. 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

    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.

  4. 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

    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.

Secondary outcomes

  1. Glomerular filtration rate evolution

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

    CKDepi (Chronic Kidney Disease - EPIdemiology, a method for estimating glomerular filtration rate) decline.

    It is calculated with a patient's age, sexe and color of their skin as well as serum creatinine rates found in urine and blood samples.

    Measured at baseline, after 15 days, 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up.

    It will be used to study the differences of glomerular filtration rate evolution between patients with ANCA vasculitis and those with other nephropathies.

  2. Urinary protein/creatinine ratio evolution

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

    Measured in urinary morning sample taken at baseline, after 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up.

    It will be used to :

    • group patients with similar characteristics in homogeneous groups.
    • study the differences in the evolution between patients with ANCA vasculitis and those with other nephropathies.
    • identify similaritites in patients trajectories according to which nephropathy they were diagnosed with.

  3. Urinary albumin/creatinine evolution ratio

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

    Measured in urinary morning sample taken at baseline, after 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up.

    It will be used to :

    • group patients with similar characteristics in homogeneous groups.
    • study the differences in the evolution between patients with ANCA vasculitis and those with other nephropathies.
    • identify similaritites in patients trajectories according to which nephropathy they were diagnosed with.

  4. Lipidomic analysis

    Time frame: Through study from baseline until one year visit.

    Measured in urinary morning sample taken at baseline, after 15 days, 2 months, 6 months and one year.

    More specifically there will be an anatomopathological analysis of lipid content (oil red o, Luxol blue, Nile red staining).

    It will be used to group patients with similar characteristics in homogeneous groups and identify similaritites in patients trajectories according to which nephropathy they were diagnosed with.

  5. Metabolomic analysis

    Time frame: Through study from baseline until one year visit.

    Measured in urinary morning sample taken at baseline, after 15 days, 2 months, 6 months and one year.

    It will be used to group patients with similar characteristics in homogeneous groups and identify similaritites in patients trajectories according to which nephropathy they were diagnosed with.

  6. Proportion of fibrotic tissues

    Time frame: At baseline.

    Measured in % with biopsy at the beginning of study. It will be used to study the impact of interstitial fibrosis in the relation between tubular dysmetabolism and ANCA vasculitis against other nephropathies.

  7. Capillary density

    Time frame: At baseline.

    Measured with biopsy at the beginning of study. It will be used to study the impact of interstitial fibrosis in the relation between tubular dysmetabolism and ANCA vasculitis against other nephropathies

  8. Markers of podocytes, renal epithelial cells and specific leukocyte populations

    Time frame: At baseline.

    Measured with biopsy at the beginning of study. It will be used to study the impact of interstitial fibrosis in the relation between tubular dysmetabolism and ANCA vasculitis against other nephropathies

  9. Quantification of fibrosis

    Time frame: At baseline.

    Measured with biopsy at the beginning of the study, by Sirius Red staining. It will be used to study the impact of interstitial fibrosis in the relation between tubular dysmetabolism and ANCA vasculitis against other nephropathies

  10. IMC (imaging mass cytometry)

    Time frame: At baseline.

    Tubular cell labeling with dedifferentiation at the beginning of study. It will be used to study the impact of interstitial fibrosis in the relation between tubular dysmetabolism and ANCA vasculitis against other nephropathies.

  11. Transcriptomic analysis

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

    Measured with biopsy at the beginning of study and blood sample taken at baseline, after 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up.

    More specifically an anatomopathological analysis with single cell transcriptomic analyses along a study of gene expression (epigenetic deregulation) will be carried out.

    It will be used to group patients with similar characteristics in homogeneous groups and identify similaritites in patients trajectories according to which nephropathy they were diagnosed with.

  12. Diastole

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

    Measured in mmHg (average of 3 measures) at baseline, after 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up.

    It will be used to group patients with similar characteristics in homogeneous groups and identify similaritites in patients trajectories according to which nephropathy they were diagnosed with.

  13. Systole

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

    Measured in mmHg (average of 3 measures) at baseline, after 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up.

    It will be used to group patients with similar characteristics in homogeneous groups and identify similaritites in patients trajectories according to which nephropathy they were diagnosed with.

  14. Heart rate

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

    Measured in beat per minute (average of 3 measures) at baseline, after 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up.

    It will be used to group patients with similar characteristics in homogeneous groups and identify similaritites in patients trajectories according to which nephropathy they were diagnosed with.

  15. Blood count analysis

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

    Measures on leukocytes, red blood cells and platelets with blood samples taken at baseline, after 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up.

    It will be used to group patients with similar characteristics in homogeneous groups and identify similaritites in patients trajectories according to which nephropathy they were diagnosed with.

  16. Leukocytes evolution

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

    Measured in several ways :

    • by blood count with blood samples taken at baseline, after 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up
    • through anatomopathological analysis by IMC with the biopsy core taken at the beginning of the study
    • specific leukocytes population will be studied for interstitial fibrosis assessment Measured at baseline, after 15 days, 2 months, 6 months and then every 6 months until the last patients completed 1 year follow-up.

    They will be used to :

    • study the differences in the evolution between patients with ANCA vasculitis and those with other nephropathies.
    • identify similaritites in patients trajectories according to which nephropathy they were diagnosed with.
    • study the impact of interstitial fibrosis in the relation between tubular dysmetabolism and ANCA vasculitis against other nephropathies.

Study contacts

Contact information is provided by the study sponsor or research team.

Laura LE MAO

CONTACT

[email protected]

+33 1 56 09 54 97

Maxime BRUSSIEUX

CONTACT

[email protected]

+33 1 44 84 17 89

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • Ministry of Health, France
  • National Research Agency, France

Registry information

Acronym: PROTECT-Fi

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 8, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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