| Primary safety endpoint |
Time to first MACE (all cause mortality, non-fatal MI, non-fatal stroke) |
| Key secondary safety endpoints |
Time to first expanded MACE: MACE plus hospitalization for HF or thromboembolic event, excluding vascular access failure |
| Time to cardiovascular mortality, non-fatal MI or non-fatal stroke |
| Time to cardiovascular mortality |
| Time to all-cause mortality |
| Other safety endpoints |
Time to first individual components of MACE: non-fatal MI, non-fatal stroke Time to non-cardiovascular mortality Time to first individual component of expanded MACE: MACE plus thromboembolic event; MACE plus thromboembolic event, excluding vascular access failure; MACE plus hospitalization for HF; MACE plus hospitalization for HF or thromboembolic event TEAEs and TESAEs Systolic and diastolic blood pressure Any value of Hb >12.0, >13.0, >14.0, <9.0 or <8.0 g/dL An Hb increase >1.0 g/dL within any 2-week interval or >2.0 g/dL within any 4-week interval
|
| Primary efficacy endpoint |
Change in average Hb between baseline and the primary evaluation period (Weeks 24–36) |
| Key secondary efficacy endpoint |
Change in average Hb value between baseline and the secondary evaluation period (Weeks 40–52) |
| Other efficacy endpoints |
Proportion of patients having average Hb value in the geography-specific target range in Weeks 24–36 Proportion of patients having average Hb value in the geography-specific target range in Weeks 40–52 Proportion of patients receiving RBC transfusions
|
| Endpoints of special interest |
Mean and percentage change in hepcidin between baseline and the primary (Weeks 24–36) and secondary (Weeks 40–52) evaluation periods Mean and percentage change in ferritin between baseline and the primary (Weeks 24–36) and secondary (Weeks 40–52) evaluation periods Mean and percentage change in TSAT between baseline and the primary (Weeks 24–36) and secondary (Weeks 40–52) evaluation periods
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