ANCA Associated VasculitisPROTECT-FiNCT07010250
Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis
An observational study of ANCA Associated Vasculitis and Extramembranous Glomerulopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ANCA Associated Vasculitis, Extramembranous Glomerulopathy, Nephrotic Syndrome, Minimal Change
- How many people
- 146 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2025to 2 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Georges-Pompidou European Hospital, AP-HP
Paris
Marine Livrozet, marine.livrozet@aphp.fr
About this study
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.
Read the 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.
- Conditions
- ANCA Associated Vasculitis, Extramembranous Glomerulopathy, Nephrotic Syndrome, Minimal Change, Interstitial Nephritis, IgA Nephropathy, Segmental Hyalinosis
- Keywords
- nephropathy, cohort
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Glomerulonephritis, Membranous, Nephrosis, Lipoid, Nephritis, Interstitial, Glomerulonephritis, IGA, Glomerulosclerosis, Focal Segmental, Diabetic Nephropathies, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ANCA Associated Vasculitis | Case | |
| Extramembranous Glomerulopathy | Control | |
| Nephrotic Syndrome, Minimal Change | Control | |
| Interstitial Nephritis | Control | |
| IgA Nephropathy | Control | |
| Segmental Hyalinosis | Control | |
| Diabetic Nephropathy | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion up to end of study, when the last patients completed 1 year follow-up
Secondary outcomes (16)
Glomerular filtration rate evolution
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.
Measured: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Urinary protein/creatinine ratio evolution
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.
Measured: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Urinary albumin/creatinine evolution ratio
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.
Measured: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Lipidomic analysis
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.
Measured: Through study from baseline until one year visit.
Metabolomic analysis
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.
Measured: Through study from baseline until one year visit.
Proportion of fibrotic tissues
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.
Measured: At baseline.
Capillary density
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
Measured: At baseline.
Markers of podocytes, renal epithelial cells and specific leukocyte populations
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
Measured: At baseline.
Quantification of fibrosis
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
Measured: At baseline.
IMC (imaging mass cytometry)
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.
Measured: At baseline.
Transcriptomic analysis
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.
Measured: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Diastole
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.
Measured: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Systole
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.
Measured: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Heart rate
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.
Measured: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Blood count analysis
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.
Measured: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Leukocytes evolution
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.
Measured: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start3 Nov 2025
- Primary completion2 Nov 2029 (estimated)
- Study completion2 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA Associated VasculitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Marine LIVROZET, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010250
- Sponsor's protocol ID
- APHP211383
- Other IDs
- PRTS-21-0009
- Acronym
- PROTECT-Fi
- Status last verified
- Jun 2026
- First submitted
- 5 May 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis
- ClinicalTrials.gov ID
- NCT07010250
- Acronym / sponsor ID
- PROTECT-Fi / APHP211383
- Conditions
- ANCA Associated Vasculitis, Extramembranous Glomerulopathy, Nephrotic Syndrome, Minimal Change, Interstitial Nephritis, IgA Nephropathy, Segmental Hyalinosis
- Keywords
- nephropathy, cohort
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France, Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 2 Nov 2029 (estimated)
- Study completion
- 2 Nov 2029 (estimated)
- First posted
- 8 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| ANCA Associated Vasculitis | – | –Case |
| Extramembranous Glomerulopathy | – | –Control |
| Nephrotic Syndrome, Minimal Change | – | –Control |
| Interstitial Nephritis | – | –Control |
| IgA Nephropathy | – | –Control |
| Segmental Hyalinosis | – | –Control |
| Diabetic Nephropathy | – | –Control |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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
- Diagnosis of ANCA vasculitis retained on renal biopsy with ANCA anti-proteinase 3 (PR3) or ANCA anti-myeloperoxidase (MPO)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
16 secondary outcomes
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.
Systole
Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Heart rate
Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Blood count analysis
Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Leukocytes evolution
Time frame: Through study completion up to end of study, when the last patients completed 1 year follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Related trials for ANCA Associated Vasculitis
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A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
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Trial of VIS954 in the Treatment of Antineutrophil Cytoplasmic Antibody-associated Vasculitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marine LIVROZET principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ANCA Associated Vasculitis and Extramembranous Glomerulopathy, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime BRUSSIEUX (+33 1 44 84 17 89, maxime.brussieux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.