Methods Of Treating Fabry Patients Having Renal Impairment

A method of stabilizing renal function in a patient diagnosed with Fabry disease and having renal impairment, the method comprising:

• a. administering to the patient an effective amount of migalastat or salt thereof at a frequency of once every other day;
• b. reducing globotriaosylceramide (GL-3) accumulated in the patient's organs;
• and
• c. reducing plasma globotriaosylsphingosine (lyso-Gb3) in the patient;
• wherein administration of a single dose of the migalastat or salt thereof to subjects with mild renal impairment provides an increase in mean plasma migalastat AUC0-∞ by about 1.2-fold compared to healthy control subjects,
• wherein administration of a single dose of the migalastat or salt thereof to subjects with moderate renal impairment provides an increase in mean plasma migalastat AUC0-∞ by about 1.8-fold compared to healthy control subjects,
• wherein administration of a single dose of the migalastat or salt thereof to subjects with severe renal impairment provides an increase in mean plasma migalastat AUC0-∞ by about 4.5-fold compared to healthy control subjects,
• wherein administration of a single dose of the migalastat or salt thereof to subjects with renal impairment provides no increase in mean plasma migalastat Cmax compared to healthy control subjects, and
• wherein the effective amount is about 100 mg to about 150 mg free base equivalent (FBE), wherein the administration of the migalastat or salt thereof is effective to stabilize renal function in the patient and wherein the patient has a HEK assay amenable mutation in α-galactosidase A.