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

Inclusion Criteria:

1. Male or female subjects aged 18 years or older, diagnosed with Fabry disease.

2. Subject (or legally authorized representative as applicable) is willing and able toprovide written informed consent and authorization for use and disclosure ofPersonal Health Information

3. Subject has a GLA variant that is amenable to migalastat recorded in their medicalrecords

4. Subject has at least 1 documented eGFR value of < 30 mL/min/1.73 m2 within the last 3 months and has an eGFRMDRD value of < 30 mL/min/1.73 m2 at Visit 1

5. Subjects with ESRD have been on a stable 2- or 3-times a week HD (standard or HDF)regimen for at least 2 months prior to the screening visit

6. Subjects with ESRD must commit to completing at least 4 standard HD or HDF sessionsduring each 2-week dosing interval.

7. Subjects with ESRD must commit to completing the entire prescribed duration for eachdialysis session.

8. If of reproductive potential, both male and female patients agree to use a medicallyaccepted method of contraception

Exclusion Criteria:

1. Subject has undergone kidney transplantation

2. Subject is on peritoneal dialysis

3. Subject is treated or has been treated with another investigational drug (exceptmigalastat) within the 30 days

4. Subject has undergone any gene therapy at any time prior to the study or anticipatesundergoing gene therapy during the study.

5. Subject has had a documented transient ischemic attack, stroke, unstable angina, ormyocardial infarction

6. Subject has clinically significant unstable cardiac disease

7. Subject has any intercurrent illness or condition that may preclude the subject fromfulfilling the protocol requirements

8. Subject has a history of allergy or sensitivity to migalastat (including excipients)or other iminosugars (eg, miglustat, miglitol)

9. Subject requires concurrent treatment with Glyset® (miglitol), Replagal® (agalsidasealfa), or Fabrazyme® (agalsidase beta)

10. Subject requires concurrent treatment with Zavesca® (miglustat) or has been treatedwith Zavesca

11. Female subject is pregnant or breast-feeding

12. Subject is unable to comply with study requirements

13. In France only, protected persons as defined by the Public Health Code