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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. 2 versions Re-verified since Mar 30, 2026, no change to tracked fieldsv26-v27
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 15 to 12
    v25
  3. Site details revised at 1 of 15 sitesv24
  4. Study sites: 13 to 15v23
  5. Re-verified, no change to tracked fieldsv22
Show 20 earlier versionsHide 20 earlier versions
  1. Secondary endpoints: 8 to 4v21
  2. Site details revised at 1 of 13 sitesv20
  3. Primary completion date: Dec 31, 2024 to Dec 31, 2026
    • Study completion date: Dec 31, 2025 to Dec 31, 2026
    • Site details revised at 1 of 13 sites
    v19
  4. Site details revised at 1 of 13 sitesv18
  5. Site details revised at 1 of 13 sitesv17
  6. Site details revised at 1 of 13 sitesv16
  7. Site details revised at 1 of 13 sitesv15
  8. Study sites: 12 to 13v14
  9. Study sites: 11 to 12v13
  10. Study sites: 9 to 11v12
  11. Primary endpoints: 21 to 22
    • Eligibility criteria expanded, about 40 words
    • Study description expanded, about 29 words
    • Site details revised at 1 of 9 sites
    v11
  12. Site details revised at 1 of 9 sitesv10
  13. Site details revised at 1 of 9 sitesv9
  14. Site details revised at 3 of 9 sitesv8
  15. Site details revised at 1 of 9 sitesv7
  16. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2022 to Oct 31, 2022
    • Site details revised at 9 of 9 sites
    v6
  17. Eligibility criteria revisedv5
  18. Start date: Oct 1, 2022 to Dec 1, 2022v4 Show 8 more changesShow less
    • Primary endpoints: 10 to 21
    • Enrollment target: 12 to 14
    • Study sites: 11 to 9
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 9 to 8
    • Study description shortened, about 72 words
    • Study arms: 1 to 2
    • Study title shortened, about 1 word
  19. Primary completion date: Dec 31, 2021 to Dec 31, 2024
    • Start date: Mar 30, 2021 to Oct 1, 2022
    • Study completion date: Dec 31, 2021 to Dec 31, 2025
    v3
  20. Primary completion date: Mar 31, 2020 to Dec 31, 2021
    • Start date: Sep 30, 2019 to Mar 30, 2021
    • Study completion date: Jun 30, 2020 to Dec 31, 2021
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT04020055
Lead Sponsor Amicus Therapeutics
Conditions
(from sponsor)		 Fabry Disease
Related terms Fabry Disease, Kidney Diseases, Kidney Failure, Chronic, Renal Insufficiency
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov