Clinical Trial

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

Active, Not Recruiting Phase 3
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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)
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2019-07-12; most recent amendment 2026-07-02.
Status change: Recruiting → Active, Not Recruiting 2026-01-13
Status change: Not Yet Recruiting → Recruiting 2023-01-11
Trial Details
NCT Number NCT04020055
Lead Sponsor Amicus Therapeutics
Conditions Fabry Disease
Enrollment 14 participants
Start Date 2022-10-31
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-06