RECRUITING

Assess Urine Biomarkers to Predict Nephropathy in Fabry Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-14
Study Completion:2025-09-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06065605

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and Female subject is greater than 18 but not older than 80 years.
  2. * Subject willing to sign the informed consent and/or assent.
  3. * Confirmed diagnosis of Fabry disease based on deficient α-Gal A enzymatic activity and molecular analysis demonstrating pathogenic variants in the GLA gene.
  1. * Any other known genetic condition associated with CKD.
  2. * Evidence of hepatitis B or C infections or other chronic infectious diseases,
  3. * Pregnancy or breastfeeding.
  4. * Any other chronic condition, as per PI's discretion, that makes the subject ineligible.

Contacts and Locations

Study Contact

Ozlem Goker-Alpan, M.D.
CONTACT
703-261-6220
Ogoker-alpan@ldrtc.org
Margarita Ivanova, Ph.D.
CONTACT
703-261-6220
mivanova@ldrtc.org

Study Locations (Sites)

Lysosomal & Rare Disorders Research & Treatment Center
Rockville, Maryland, 20853
United States
Lysosomal & Rare Disorders Research & Treatment Center
Fairfax, Virginia, 22030
United States

Collaborators and Investigators

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-14
Study Completion Date2025-09-12

Study Record Updates

Study Start Date2023-09-14
Study Completion Date2025-09-12

Terms related to this study

Keywords Provided by Researchers

  • Urine collection
  • biomarkers
  • CKD
  • Early detection

Additional Relevant MeSH Terms

  • Fabry Disease