| Outcome Measures: |
Primary: The mean change from the baseline hemoglobin level to the mean level during the evaluation period, The primary efficacy end point is the mean change from the baseline hemoglobin level to the mean level during the evaluation period. The baseline hemoglobin value is the value on the day of randomization. The mean hemoglobin during the evaluation period was calculated as the mean of all available hemoglobin values during that period. Hemoglobin measurements will be performed at baseline and thereafter every 2 weeks (for the dose adjustment and the evaluation periods). Efficacy will be also assessed as the mean change from baseline in hemoglobin levels during 4-week intervals., Week 17-24 | Secondary: The mean change from the baseline hemoglobin level to the mean level at each visit, The mean change from the baseline hemoglobin level to the mean level at each visit point. Hemoglobin measurements will be performed at every 2 weeks during the dose adjustment period (0-16 weeks) and the evaluation period (17-24 weeks) , and every 4 weeks during the extended period (25-52 weeks)., Week 0-52|The proportion of patients with hemoglobin within the target range of 10.0 to 12.0 g/dL during the evaluation period, The proportion of patients achieving a response (hemoglobin maintain in 10.0 to 12.0 g/dL during the previous 4 weeks), will be measured during the evaluation period., Week 17-24|The mean dose of patients with Pegol-Sihematide achieving a target hemoglobin range during the evaluation period, The mean dose of patients with Pegol-Sihematide will be calculated for achieving a target hemoglobin range (10.0 to 12.0 g/dL) during the evaluation period., Week 17-24|First time for patients achieving a response to hemoglobin during any treatment periods, First time for patients achieving a response (hemoglobin increase in ≥ 1.0 g/dL) during any trial periods, including the dose adjustment period (0-16 weeks), the evaluation period (17-24 weeks) and the extended period (25-52 weeks)., Week 0-52|First time for patients achieving a target hemoglobin range during any trial periods, First time for patients achieving a target hemoglobin range (hemoglobin maintain in 10.0 to 12.0 g/dL or increase in ≥ 1.0 g/dL) during any trial periods, including the dose adjustment period (0-16 weeks), the evaluation period (17-24 weeks) and the extended period (25-52 weeks)., Week 0-52 | Other: The SAE of Pegol-Sihematide, The incidence of patients who reported serious adverse events (SAE)., Week 0-52|The incidence of patients with risk cardiovascular events of Pegol-Sihematide, The incidence of patients with risk cardiovascular events, including death, stroke, myocardial infarction and severe congestive heart failure, unstable angina, arrhythmia requiring hospitalization., Week 0-52|The antibody of Pegol-Sihematide, The antibody to Pegol-Sihematide is the anti-drug antibodies of the Pegol-Sihematide., Week 0-52
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