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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Page 1 of 1 (2 locations)

1

Lysosomal & Rare Disorders Research & Treatment Center

Rockville, Maryland, United States, 20853

2

Lysosomal & Rare Disorders Research & Treatment Center

Fairfax, Virginia, United States, 22030