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Status unknownNCT03869554HISTOFABUpdated Jun 11, 2024

Evaluation of a Screening Strategy of Fabry Disease in Patient With Renal Biopsy

An interventional study of Detection of Fabry disease in Renal Disease, sponsored by University Hospital, Angers. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-11.

Sponsored by University Hospital, Angers · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jun 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Fabry disease is genetic X linked disease, with annual incidence of 1 in 100,000 that is certainly underestimate the true prevalence of the disease.

Renal biopsy in some patients does not allow determining the etiology of nephropathy. It is why investigators would like to evaluate the screening of Fabry patients from renal biopsy in patient with idiopathic nephropathy.

Investigator hypothesize to detect one or more cases of patients with Fabry disease in local idiopathic nephropathy population with renal biopsy.

That would allow reviewing and optimizing the target screening for Fabry Disease. The purpose would be to detect Fabry disease systematically in patients presenting a nephropathy of undetermined etiology in spite of the renal biopsy or presenting nonspecific histological characteristics.

In Fabry disease with renal impairment, proteinuria is the first sign, usually occurring in the second decade. The evolution is progressively towards end-stage renal failure during the fourth decade. The presence of renal impairment is globally associated with a poor prognosis.

Renal histology can be used to diagnose Fabry disease by revealing sphingolipid deposits identified by optical microscopy in the form of vacuoles in podocytes, distal tubule epithelial cells or in the media of the distal tubules. vascular walls. Resin inclusion with Toluidine blue staining is the staining of choice for visualizing lipid inclusions. However, this staining is not used as a first intention in routine. On the paraffin-fixed tissues, the vacuoles are less visible because they dissolve.

Thus, the renal histological analysis sometimes reveals only non-specific damage to the various structures of the kidney and may not allow identification of very evocative inclusions. Under the effect of oxidative stress induced by sphingolipid deposits, lesions of tubulo-interstitial fibrosis settle quite early. At the level of the glomerulus, glycosphingolipids lead to the production of angiotensin II and TGF-β leading to an excess production of constituents of the glomerular basement membrane inducing its thickening and glomerulosclerosis. Arteries of all sizes are also the seat of intimal thickening and media accelerating the process of intrarenal ischemia. These lesions, which may appear isolated or synchronous, and nonspecific, are sometimes in the foreground and do not point in the first line to the etiological diagnosis of Fabry disease.

Also, among the patients presenting a nephropathy of undetermined etiology in spite of the renal biopsy or presenting nonspecific histological characteristics, investigator propose to systematically detect the Fabry disease. Screening will be done in a selected population of renal biopsy patients using the dried blood spot kits.

02

Conditions studied

  • Renal Disease

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03

In context

Kidney Diseases

3,843 studies on the registry are indexed under Kidney Diseases; 492 are open to participants now.

This study's planned enrollment of 100 is above the median of 70 across 2,645 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 477 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patient (> 18 years old)
  • Obtaining consent to participate in the study
  • Patients whose clinical presentation meets at least one of the following criteria:

    • Undetermined nephropathy despite renal biopsy,
    • Nephroangiosclerosis as the predominant lesion
    • Chronic tubulointerstitial nephropathy,
    • Glomerulosclerosis,
    • Segmental and focal hyalinosis.
    • Optically normal kidney or seat of minimal lesions

Exclusion criteria

Exclusion Criteria:

  • Patient who has already been screened for Fabry Disease
  • At least one of the following criteria:

    • Nephrotic syndrome and/or Glomerular nephropathy
    • Histological diagnosis of certain nephropathies (specific kidney lesions)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Renal disease

    detection of Fabry disease

    Diagnostic Test: Detection of Fabry disease

Interventions

  • Diagnostic testDetection of Fabry disease

    Systematic detection of Fabry disease

06

What researchers measure

Primary outcomes

  1. Assess the value of screening for Fabry's disease in patients with kidney disease whose etiology remains undetermined after renal biopsy

    number of patients diagnosed with Fabry's disease identified

    Time frame: 1 month

Secondary outcomes

  1. Estimate the prevalence of Fabry disease

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
  • CHU Angers
    Angers, France
    • Jean-François Augusto · Contact
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2020 (actual). Primary completion is estimated for Jun 2025, 63 months after the start.

Of 510 non-industry interventional studies with no phase under Kidney Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 63 months is above that.

Counting every sponsor, half of 555 studies reached it within 23 months; a quarter within 10 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2019
First posted
Mar 11, 2019
StartActual
Feb 3, 2020
Primary completionEst.
Jun 2, 2025
CompletionEst.
Aug 2, 2025
Last update
Jun 11, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 11, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03869554
Responsible party
Sponsor
First posted
Mar 11, 2019
Start date
Feb 3, 2020
Primary completion
Jun 2, 2025 (estimated)
Completion
Aug 2, 2025 (estimated)
Last update
Jun 11, 2024

Study contacts

Jean-François AUGUSTO
Contact
jfaugusto@chu-angers.fr
02 41 35 82 02 ext. +33
Béatrice GABLE
Contact
begable@chu-angers.fr
0241356825 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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