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Epithelial Dysmetabolism and Renal Fibrosis in ANCA Vasculitis (PROTECT-Fi)

A

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

ANCA Associated Vasculitis
Diabetic Nephropathies
Extramembranous Glomerulopathy
Nephrotic Syndrome, Minimal Change
IgA Nephropathy
Interstitial Nephritis
Segmental Hyalinosis

Study type

Observational

Funder types

Other

Identifiers

NCT07010250
PRTS-21-0009 (Other Grant/Funding Number)
APHP211383

Details and patient eligibility

About

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.

Full 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.

Enrollment

146 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

146 participants in 7 patient groups

ANCA Associated Vasculitis
Description:
Case
Extramembranous Glomerulopathy
Description:
Control
Nephrotic Syndrome, Minimal Change
Description:
Control
Interstitial Nephritis
Description:
Control
IgA Nephropathy
Description:
Control
Segmental Hyalinosis
Description:
Control
Diabetic Nephropathy
Description:
Control

Trial contacts and locations

1

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Central trial contact

Laura LE MAO; Maxime BRUSSIEUX

Data sourced from clinicaltrials.gov

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