Screening for Fabry Disease in Patients with Kidney Issues
Evaluation of a Screening Strategy of Fabry Disease in Patient With Renal Biopsy: Histo-Fab Study
This study is testing a new way to check for Fabry disease in kidney patients who have had a biopsy but whose kidney problems are still unclear.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Angers Government |
| Locations | 1 site (Angers) |
| Trial ID | NCT03869554 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate a screening strategy for Fabry disease in patients who have undergone renal biopsy but have undetermined nephropathy. The investigators hypothesize that by systematically screening these patients, they can identify cases of Fabry disease that may have been overlooked. The approach focuses on patients presenting with idiopathic nephropathy or nonspecific histological characteristics. The goal is to optimize screening methods for Fabry disease in this population.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with undetermined nephropathy despite renal biopsy or specific kidney lesions.
Not a fit: Patients who have already been screened for Fabry disease or have certain diagnosed nephropathies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and treatment of Fabry disease in patients with unexplained kidney problems.
How similar studies have performed: While the approach of screening for Fabry disease in this context is innovative, similar studies have not been widely reported, indicating this may be a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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)
Where this trial is running
Angers
- CHU Angers — Angers, France (Recruiting)
Study contacts
- Study coordinator: Jean-François AUGUSTO
- Email: jfaugusto@chu-angers.fr
- Phone: 02 41 35 82 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.