Outcome Measures: |
Primary: Hemoglobin (Hb) Response rate, Hb response is defined as reaching target values for Hb and change of Hb from baseline, Up to Week 24 | Secondary: Average Hb level from Week 18 to 24, Week 18 to 24|Change from baseline in the average Hb level from Week 18 to 24, Baseline and Weeks 18 to 24|Proportion of participants with the target Hb level from Week 18 to 24, Week 18 to 24|Rate of rise in Hb levels (g/dL/week) from week 0 to at the earliest date of week 4, time of discontinuation, or time of dose adjustment, Up to Week 4|Proportion of measurement points with the target Hb level, Up to Week 24|Proportion of participants with the target Hb level at each week, Up to Week 24|Proportion of participants with 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 levels to each week, Baseline and 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|Quality of life assessed by EQ-5D-5L, EQ-5D-5L: 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 hospitalizations, Up to Week 24|Duration of hospitalizations, Up to Week 24|Safety assessed by incidence of adverse events, Up to Week 24|Number of participants with abnormal Laboratory values and/or adverse events related to treatment, 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 standard 12-lead electrocardiogram, Up to Week 24|Plasma concentration of unchanged ASP1517, Up to Week 24
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Locations: |
Site JP00003, Aichi, Japan|Site JP00005, Aichi, Japan|Site JP00042, Aichi, Japan|Site JP00044, Aichi, Japan|Site JP00020, Chiba, Japan|Site JP00010, Ehime, Japan|Site JP00021, Ehime, Japan|Site JP00013, Fukuoka, Japan|Site JP00011, Fukushima, Japan|Site JP00035, Fukushima, Japan|Site JP00017, Gifu, Japan|Site JP00033, Gifu, Japan|Site JP00012, Gunma, Japan|Site JP00016, Gunma, Japan|Site JP00025, Gunma, Japan|Site JP00046, Hiroshima, Japan|Site JP00015, Hokkaido, Japan|Site JP00023, Hokkaido, Japan|Site JP00028, Hokkaido, Japan|Site JP00038, Hokkaido, Japan|Site JP00040, Hokkaido, Japan|Site JP00045, Hokkaido, Japan|Site JP00034, Hyogo, Japan|Site JP00008, Ibaraki, Japan|Site JP00018, Ibaraki, Japan|Site JP00027, Ibaraki, Japan|Site JP00030, Ibaraki, Japan|Site JP00022, Ishikawa, Japan|Site JP00041, Kagoshima, Japan|Site JP00031, Kumamoto, Japan|Site JP00037, Kumamoto, Japan|Site JP00009, Nagano, Japan|Site JP00014, Nagano, Japan|Site JP00026, Nagano, Japan|Site JP00047, Nagano, Japan|Site JP00002, Niigata, Japan|Site JP00029, Niigata, Japan|Site JP00039, Okayama, Japan|Site JP00024, Okinawa, Japan|Site JP00036, Osaka, Japan|Site JP00006, Saitama, Japan|Site JP00032, Shizuoka, Japan|Site JP00043, Tokushima, Japan|Site JP00048, Tokyo, Japan|Site JP00007, Tottori, Japan|Site JP00019, Toyama, Japan|Site JP00004, Yamaguchi, Japan
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