Status:
UNKNOWN
Assess Urine Biomarkers to Predict Nephropathy in Fabry Disease
Lead Sponsor:
Lysosomal and Rare Disorders Research and Treatment Center, Inc.
Conditions:
Fabry Disease
Eligibility:
All Genders
18-80 years
Brief Summary
The purpose of this research is to collect biological samples (urine) to develop assays for immune biomarkers to possibly in the future be able to screen subjects with Fabry disease and be able to und...
Detailed Description
This is a study to assess the markers related to autophagy, apoptosis, pyroptosis, and inflammatory markers related to NFkB, TNF-alpha, and TGF-β1 pathways in the urine. Urinary biomarkers will then b...
Eligibility Criteria
Inclusion
- Male and Female subject is greater than 18 but not older than 80 years.
- Subject willing to sign the informed consent and/or assent.
- Confirmed diagnosis of Fabry disease based on deficient α-Gal A enzymatic activity and molecular analysis demonstrating pathogenic variants in the GLA gene.
Exclusion
- Any other known genetic condition associated with CKD.
- Evidence of hepatitis B or C infections or other chronic infectious diseases,
- Pregnancy or breastfeeding.
- Any other chronic condition, as per PI's discretion, that makes the subject ineligible.
Key Trial Info
Start Date :
September 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 12 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06065605
Start Date
September 14 2023
End Date
September 12 2025
Last Update
October 4 2023
Active Locations (2)
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1
Lysosomal & Rare Disorders Research & Treatment Center
Rockville, Maryland, United States, 20853
2
Lysosomal & Rare Disorders Research & Treatment Center
Fairfax, Virginia, United States, 22030