| Outcome Measures: |
Primary: Change from baseline in hemoglobin (Hb) response rate, Hb response is defined as reaching target values for Hb., Baseline and week 24 | Secondary: Change from baseline in the average Hb from Week 18 to Week 24, Baseline and Weeks 18 to 24|Proportion of participants who achieve the target Hb level at the average of Week 18 to 24, Hb response defined as average Hb within the target range in this outcome, Weeks 18 to 24|Rate of rise in Hb levels (g/dL/week) from week 0 at the earliest date of week 4, time to discontinuation, or time of dose adjustment, Up to Week 4|Proportion of measurement points with the target Hb level, Weeks 18 to 24|Proportion of participants who achieves the target Hb level at each week, Up to Week 24|Proportion of participants who achieves the lower limit of the target Hb level, Up to Week 24|Time to achieve the lower limit of the target Hb level, Up to Week 24|Change from baseline in Hb level to each week, Baseline and Up to Week 24|Quality of life assessed by EQ-5D-5L, EQ-5D: EuroQol 5 Dimension 5 Levels, Up to Week 24|Quality of life assessed by FACT-An, FACT-An: Functional Assessment of Cancer Therapy-Anemia, Up to Week 24|Number of participants with abnormal Vital signs and/or adverse events related to treatment, Up to Week 24|Safety assessed by body weight, Up to Week 24|Safety assessed by incidence of adverse events, Up to Week 24|Safety assessed by standard 12-lead electrocardiogram, Up to Week 24|Number of participants with abnormal Laboratory values and/or adverse events related to treatment, Up to Week 24|Plasma concentration of unchanged ASP1517, Up to Week 24|Average hematocrit level, Up to Week 24|Average reticulocyte level, Up to Week 24|Average iron (Fe) level, Up to Week 24|Average ferritin level, Up to Week 24|Average transferrin level, Up to Week 24|Average total iron binding capacity level, Up to Week 24|Average soluble transferrin receptor level, Up to Week 24|Average transferrin saturation level, Up to Week 24|Average reticulocyte hemoglobin content level, Up to Week 24|Number of hospitalizations, Up to Week 24|Duration of hospitalizations, Up to Week 24
|
| Locations: |
Site JP00007, Aichi, Japan|Site JP00018, Aichi, Japan|Site JP00028, Aichi, Japan|Site JP00001, Chiba, Japan|Site JP00035, Ehime, Japan|Site JP00012, Fukui, Japan|Site JP00011, Fukuoka, Japan|Site JP00031, Fukuoka, Japan|Site JP00030, Hiroshima, Japan|Site JP00034, Hiroshima, Japan|Site JP00036, Hiroshima, Japan|Site JP00005, Hokkaido, Japan|Site JP00020, Hyogo, Japan|Site JP00015, Ibaraki, Japan|Site JP00017, Ibaraki, Japan|Site JP00021, Ibaraki, Japan|Site JP00025, Ibaraki, Japan|Site JP00037, Ibaraki, Japan|Site JP00033, Ishikawa, Japan|Site JP00029, Iwate, Japan|Site JP00006, Kanagawa, Japan|Site JP00014, Kanagawa, Japan|Site JP00038, Kanagawa, Japan|Site JP00010, Miyagi, Japan|Site JP00016, Nagano, Japan|Site JP00024, Niigata, Japan|Site JP00032, Oita, Japan|Site JP00003, Osaka, Japan|Site JP00009, Osaka, Japan|Site JP00026, Osaka, Japan|Site JP00002, Saitama, Japan|Site JP00019, Saitama, Japan|Site JP00027, Saitama, Japan|Site JP00004, Tokyo, Japan|Site JP00013, Tokyo, Japan|Site JP00022, Tokyo, Japan|Site JP00023, Tokyo, Japan|Site JP00008, Toyama, Japan
|
