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
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.
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 →University Hospital, Angers is the lead sponsor of 477 studies on the registry; 119 are open to participants now.
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Patients whose clinical presentation meets at least one of the following criteria:
Exclusion Criteria:
At least one of the following criteria:
detection of Fabry disease
Diagnostic Test: Detection of Fabry disease
Systematic detection of Fabry disease
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
Estimate the prevalence of Fabry disease
Time frame: 12 months
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.
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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