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ACTIVE NOT RECRUITING
NCT04020055
PHASE3

A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease

Sponsor: Amicus Therapeutics

View on ClinicalTrials.gov

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

DRUG

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