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A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease
Sponsor: Amicus Therapeutics
Summary
An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects with Fabry Disease and Amenable GLA Variants and Severe Renal Impairment (SRI) or End Stage Renal Disease (ESRD)
Official title: An Open-label Study to Evaluate the Safety and Pharmacokinetics of Migalastat HCl in Subjects With Fabry Disease and Amenable GLA Variants and Severe Renal Impairment or End-Stage Renal Disease Treated With Hemodialysis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2022-10-31
Completion Date
2026-12-31
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
migalastat HCl 150 mg
migalastat HCl 150 mg capsule
Locations (12)
Emory University
Atlanta, Georgia, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Lysosomal and Rare Disorders Research and Treatment Center, Inc
Fairfax, Virginia, United States
Royal Melbourne Hospital
Parkville, Victoria, Australia
Royal Perth Hospital
Perth, Washington, Australia
Osaka University Hospital
Suita, Osaka, Japan
Shizuoka General Hospital
Shizuoka, Shizuoka, Japan
Centro Hospitalar e Universitário de Coimbra (CHUC)
Coimbra, Portugal
Hospital Universitari(o) de Bellvitge (HUB) Feixa Llarga
Barcelona, Spain
Hospital General Universitario de Elda
Elda, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Salford Royal Hospital
Salford, England, United Kingdom