Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT02994303

Conditions

Fabry Disease

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

In patients with Fabry disease, this research study explores the presence of podocytes in their urine as a potential non-invasive biomarker for baseline kidney disease; and explores changes in the quantity of podocytes in their urine over time as a predictor for kidney disease progression. To accomplish this, the investigators will evaluate the quantification of podocytes in the urine of Fabry disease patients at baseline and longitudinally over time. This study requires a single patient visit, during which the patient provides a urine specimen. The research team will then collect the patient's kidney function data proximate to the time of urine collection, and follow the patient's kidney function data longitudinally over the five years of this study by reviewing their medical charts. The study offers no interventions.

Conditions

Fabry Disease

Study ID

NCT02994303

Start date

Sep, 2014

Status verified date

Aug, 2017

Completion date

Aug, 2019

Anticipated

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patients must have been diagnosed with Fabry disease
  • Patients must be between the ages of 1 day-90 years

Exclusion Criteria:

  • Fabry disease patients who have had a renal transplant
  • Fabry disease patients who are, or have been, subjects in any investigational drug study

Study Design

Enrollment

58 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Detection of Podocyturia in Subjects Diagnosed with Fabry Disease [ Time Frame: At time of enrollment ]

Central Contacts and Locations

Central contacts

Behzad Najafian, M.D.

206-897-5596najafian@u.washington.edu

Cindy M. Tower

206-616-5464cmschnei@u.washington.edu

Locations

Emory University

Recruiting

Decatur, Georgia, United States, 30033

Contacts

Dawn Laney, MS,CGC, CCRC

404-778-8518dawn.laney@emory.edu

Principal Investigator:

Dawn Laney, MS,CGC, CCRC

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Michael Mauer, MD

612-624-4688pinth001@umn.edu

Cathy A Bagne

612-624-4688pinth001@umn.edu

Principal Investigator:

Michael Mauer, MD

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Cindy M. Tower

206-616-5464cmschnei@u.washington.edu

Principal Investigator:

Behzad Najafian, M.D.

More Information

Sponsor

University of Washington

Last update posted

Aug 28, 2017

Last verified

Aug, 2017

Keywords

  • Fabry disease
  • Fabry nephropathy
  • end-stage renal disease
  • Anderson-Fabry disease
  • Fabry's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2017-08-28.