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| ID | Type | Description | Link |
|---|---|---|---|
| PRTS-21-0009 | Other Grant/Funding Number | Ministry of health, France |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| National Research Agency, France | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ANCA Associated Vasculitis | Case | ||
| Extramembranous Glomerulopathy | Control | ||
| Nephrotic Syndrome, Minimal Change | Control | ||
| Interstitial Nephritis | Control | ||
| IgA Nephropathy | Control | ||
| Segmental Hyalinosis | Control | ||
| Diabetic Nephropathy | Control |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Marine LIVROZET | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georges-Pompidou European Hospital, AP-HP | Recruiting | Paris | France |
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Two years after the last publication
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).
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| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D015433 | Glomerulonephritis, Membranous |
| D009402 | Nephrosis, Lipoid |
| D009395 | Nephritis, Interstitial |
| D005922 | Glomerulonephritis, IGA |
| D005923 | Glomerulosclerosis, Focal Segmental |
| D003928 | Diabetic Nephropathies |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Additional research analyzes on the care biopsy specimen, DNA, serum and plasma biobank, urine samples for lipidomic sudies.
| 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 :
| 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 :
| 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. | 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. | 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. | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | Through study completion up to end of study, when the last patients completed 1 year follow-up. |
| Leukocytes evolution | Measured in several ways :
They will be used to :
| Through study completion up to end of study, when the last patients completed 1 year follow-up. |
| D017445 |
| Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D009401 | Nephrosis |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |