| Outcome Measures: |
Primary: Change from baseline in the average Hemoglobin (Hb), Baseline and Weeks 18 to 24 | Secondary: Average Hb from Week 18 to Week 24, Up to Week 24|Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 18 to 24, Weeks 18 to 24|Number of participants who achieve the target Hb level at each week, Up to Week 24|Change from baseline in Hb to each post-dosing time point, Baseline and Up to Week 52|Proportion of time points that achieve the target Hb level from Weeks 18 to 24, Up to Week 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|Quality of life assessed by SF-36, SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey, Up to Week 52|Quality of life assessed by EQ-5D-5L, EQ-5D: EuroQol 5 Dimension 5 Levels, Up to Week 52|Quality of life assessed by WPAI:ANS, WPAI:ANS: Work Productivity and Activity Impairment Questionnaire: Anaemic Symptoms, Up to Week 52|Quality of life assessed by FACT-An, FACT-An: Functional Assessment of Cancer Therapy-Anemia, Up to Week 52|Average Hb from weeks 44 to 52, Up to Week 52|Change from baseline in the average Hb from weeks 44 to 52, Baseline and Up to Week 52|Number of Participants Who Achieved the Average Hb level of 10.0 to 12.0 g/dL For Weeks 44 to 52, Weeks 44 to 52|Number of participants who achieve the target Hb level at each week, Up to Week 52|Proportion of time points that achieve the target Hb level from Weeks 44 to 52, Up to Week 52|Average Hematocrit Level, Up to Week 52|Average Reticulocyte Level, Up to Week 52|Average Ferrum Level, Up to Week 52|Average Ferritin Level, Up to Week 52|Average Transferrin Level, Up to Week 52|Average Total Iron Binding Capacity Level, Up to Week 52|Average Soluble Transferrin Receptor Level, Up to Week 52|Average Soluble Transferrin Level, Up to Week 52|Average Reticulocyte Hemoglobin Content Level, Up to Week 52|Number of Occurence of Hospitalizations, Up to Week 52|Duration of Hospitalization, Up to week 52|Number of participants with abnormal Vital signs and/or adverse events related to treatment, Up to Week 52|Safety assessed by body weight, Up to Week 52|Safety assessed by incidence of adverse events, Up to Week 52|Safety assessed by standard 12-lead electrocardiogram, Up to Week 52|Safety assessed by ophthalmological examination: Fundoscopy, Up to Week 24|Safety assessed by ophthalmological examination: optical coherence tomography, Up to Week 24|Safety assessed by ophthalmological examination: visual acuity, Up to Week 24|Number of participants with abnormal Laboratory values and/or adverse events related to treatment, Up to Week 52|Plasma concentration of unchanged ASP1517, Up to Week 24
|
| Locations: |
Site JP00009, Kasugai, Aichi, Japan|Site JP00030, Nagoya, Aichi, Japan|Site JP00051, Nagoya, Aichi, Japan|Site JP00021, Toyohashi, Aichi, Japan|Site JP00003, Sakura, Chiba, Japan|Site JP00038, Matsuyama, Ehime, Japan|Site JP00044, Matsuyama, Ehime, Japan|Site JP00008, Kitakyusyu, Fukuoka, Japan|Site JP00013, Kitakyusyu, Fukuoka, Japan|Site JP00040, Kitakyusyu, Fukuoka, Japan|Site JP00057, Kitakyusyu, Fukuoka, Japan|Site JP00042, Kurume, Fukuoka, Japan|Site JP00041, Tajimi, Gifu, Japan|Site JP00002, Maebashi, Gunma, Japan|Site JP00037, Hatsukaichi, Hiroshima, Japan|Site JP00050, Kure, Hiroshima, Japan|Site JP00049, Aasahikawa, Hokkaido, Japan|Site JP00007, Sapporo, Hokkaido, Japan|Site JP00064, Sapporo, Hokkaido, Japan|Site JP00022, Amagasaki, Hyogo, Japan|Site JP00066, Nishinomiya, Hyogo, Japan|Site JP00052, Hitachi, Ibaraki, Japan|Site JP00017, Kasama, Ibaraki, Japan|Site JP00028, Koga, Ibaraki, Japan|Site JP00053, Naka, Ibaraki, Japan|Site JP00023, Sashima-gun, Ibaraki, Japan|Site JP00019, Toride, Ibaraki, Japan|Site JP00046, Tsuchiura, Ibaraki, Japan|Site JP00035, Kanazawa, Ishikawa, Japan|Site JP00031, Morioka, Iwate, Japan|Site JP00047, Fujisawa, Kanagawa, Japan|Site JP00001, Kamakura, Kanagawa, Japan|Site JP00016, Yokohama, Kanagawa, Japan|Site JP00048, Yokohama, Kanagawa, Japan|Site JP00012, Sendai, Miyagi, Japan|Site JP00036, Ueda, Nagano, Japan|Site JP00059, Higashiosaka, Osaka, Japan|Site JP00005, Izumisano, Osaka, Japan|Site JP00011, Sakai, Osaka, Japan|Site JP00069, Yao, Osaka, Japan|Site JP00029, Ageo, Saitama, Japan|Site JP00004, Koshigaya, Saitama, Japan|Site JP00020, Koshigaya, Saitama, Japan|Site JP00025, Adachi-ku, Tokyo, Japan|Site JP00043, Bunkyo-ku, Tokyo, Japan|Site JP00063, Chiyoda-ku, Tokyo, Japan|Site JP00067, Hino, Tokyo, Japan|Site JP00015, Koto-ku, Tokyo, Japan|Site JP00024, Minato-ku, Tokyo, Japan|Site JP00006, Musashino, Tokyo, Japan|Site JP00060, Ota-ku, Tokyo, Japan|Site JP00062, Tachikawa, Tokyo, Japan|Site JP00014, Fukui, Japan|Site JP00033, Fukuoka, Japan|Site JP00065, Fukuoka, Japan|Site JP00032, Hiroshima, Japan|Site JP00039, Hiroshima, Japan|Site JP00045, Kyoto, Japan|Site JP00018, Nagano, Japan|Site JP00068, Nagano, Japan|Site JP00026, Niigata, Japan|Site JP00034, Oita, Japan|Site JP00055, Okayama, Japan|Site JP00056, Osaka, Japan|Site JP00061, Osaka, Japan|Site JP00010, Toyama, Japan
|
