Overview
Study ID-069A302 will continue at each site until lucerastat is commercially available in the respective country or until all subjects have reached Month 24 (for subjects participating only in Stage 1) or Month 48 (for subjects participating in Stages 1 and 2) or Month 72 (for subjects participating in Stages 1, 2 and 3), whichever is earliest.
Principal investigator
Eligibility criteria
Inclusion Criteria:
* Signed ICF prior to any study-mandated procedure;
* Subject completed the 6-month, double-blind treatment period in study ID 069A301
* Woman of childbearing potential only if agreement 1) to follow a specified contraception scheme, 2) to undertake monthly urine pregnancy tests.
* Fertile male only if agreement 1) to use a condom, 2) to not father a child.
Exclusion Criteria:
* Pregnant / planning to be become pregnant or lactating subject;
* Subject considered to be at high risk of developing clinical signs of organ involvement within the time period of the study, as per investigator judgment;
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results as per investigator judgment. In addition, the subject must not be enrolled in study ID-069A302 if at any time during study ID-069A301, one of the following criteria was met:
* Subject's eGFR per the Chronic Kidney Disease Epidemiology Collaboration creatinine equation \< 15 mL/min/1.73 m2;
* Subject experienced an event of acute kidney injury Common Terminology Criteria for Adverse Event (CTCAE) grade 2 or above;
* Subject experienced an event of stroke CTCAE grade 3 or above;
* Subject experienced an event of heart failure leading to in-patient hospitalization or prolongation of ongoing hospitalization.
* Signed ICF prior to any study-mandated procedure;
* Subject completed the 6-month, double-blind treatment period in study ID 069A301
* Woman of childbearing potential only if agreement 1) to follow a specified contraception scheme, 2) to undertake monthly urine pregnancy tests.
* Fertile male only if agreement 1) to use a condom, 2) to not father a child.
Exclusion Criteria:
* Pregnant / planning to be become pregnant or lactating subject;
* Subject considered to be at high risk of developing clinical signs of organ involvement within the time period of the study, as per investigator judgment;
* Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results as per investigator judgment. In addition, the subject must not be enrolled in study ID-069A302 if at any time during study ID-069A301, one of the following criteria was met:
* Subject's eGFR per the Chronic Kidney Disease Epidemiology Collaboration creatinine equation \< 15 mL/min/1.73 m2;
* Subject experienced an event of acute kidney injury Common Terminology Criteria for Adverse Event (CTCAE) grade 2 or above;
* Subject experienced an event of stroke CTCAE grade 3 or above;
* Subject experienced an event of heart failure leading to in-patient hospitalization or prolongation of ongoing hospitalization.
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