Assess Urine Biomarkers to Predict Nephropathy in Fabry Disease

Description

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 understand better progression of nephropathy in Fabry disease and predict nephropathy in Fabry disease.

Conditions

Fabry Disease

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Study Overview

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Study Details

Study overview

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 understand better progression of nephropathy in Fabry disease and predict nephropathy in Fabry disease.

Pilot Study to Assess Clinical and Pivotal Biomarkers in the Urine to Predict the Progression of Nephropathy in Fabry Disease

Assess Urine Biomarkers to Predict Nephropathy in Fabry Disease

Condition
Fabry Disease
Intervention / Treatment

-

Contacts and Locations

Rockville

Lysosomal & Rare Disorders Research & Treatment Center, Rockville, Maryland, United States, 20853

Fairfax

Lysosomal & Rare Disorders Research & Treatment Center, Fairfax, Virginia, United States, 22030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Lysosomal and Rare Disorders Research and Treatment Center, Inc.,

Study Record Dates

2025-09-12