Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Kidney transplant patient

Patient on dialysis (hemodialysis or peritoneal dialysis)

Patient under legal protection, guardianship or curatorship

Pregnancy or breastfeeding

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

146 Participants
are grouped into 7 trial groups

7

Trial groups

See each trial group below.

Group A: ANCA Associated Vasculitis
Group B: Extramembranous Glomerulopathy
Group C: Nephrotic Syndrome, Minimal Change
Group D: Interstitial Nephritis
Group E: IgA Nephropathy
Group F: Segmental Hyalinosis
Group G: Diabetic Nephropathy

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion up to end of study, when the last patients completed 1 year follow-up.
2

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.

Time frame
Through study completion up to end of study, when the last patients completed 1 year follow-up
3

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.

Time frame
Through study completion up to end of study, when the last patients completed 1 year follow-up
4

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.

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

Secondary outcomes

1

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.

Time frame
Through study completion up to end of study, when the last patients completed 1 year follow-up.
2

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.

Time frame
Through study completion up to end of study, when the last patients completed 1 year follow-up.
3

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.

Time frame
Through study completion up to end of study, when the last patients completed 1 year follow-up.
4

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.

Time frame
Through study from baseline until one year visit.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Ministry of Health, France

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France

Collaborator

National Research Agency, France

Collaborator