The objective of this study is to evaluate the efficacy and the safety when ASP1517 is intermittently administered in Erythropoiesis Stimulating Agent (ESA)-untreated non-dialysis chronic kidney disease patients with anemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Oral administration
Site JP00029
Numakunai, Iwate, Japan
Change from baseline in hemoglobin (Hb) response rate
Hb response is defined as reaching target values for Hb.
Time frame: Baseline and week 24
Change from baseline in the average Hb from Week 18 to Week 24
Time frame: 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
Time frame: 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
Time frame: Up to Week 4
Proportion of measurement points with the target Hb level
Time frame: Weeks 18 to 24
Proportion of participants who achieves the target Hb level at each week
Time frame: Up to Week 24
Proportion of participants who achieves the lower limit of the target Hb level
Time frame: Up to Week 24
Time to achieve the lower limit of the target Hb level
Time frame: Up to Week 24
Change from baseline in Hb level to each week
Time frame: Baseline and Up to Week 24
Quality of life assessed by EQ-5D-5L
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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
...and 28 more locations
EQ-5D: EuroQol 5 Dimension 5 Levels
Time frame: Up to Week 24
Quality of life assessed by FACT-An
FACT-An: Functional Assessment of Cancer Therapy-Anemia
Time frame: Up to Week 24
Number of participants with abnormal Vital signs and/or adverse events related to treatment
Time frame: Up to Week 24
Safety assessed by body weight
Time frame: Up to Week 24
Safety assessed by incidence of adverse events
Time frame: Up to Week 24
Safety assessed by standard 12-lead electrocardiogram
Time frame: Up to Week 24
Number of participants with abnormal Laboratory values and/or adverse events related to treatment
Time frame: Up to Week 24
Plasma concentration of unchanged ASP1517
Time frame: Up to Week 24
Average hematocrit level
Time frame: Up to Week 24
Average reticulocyte level
Time frame: Up to Week 24
Average iron (Fe) level
Time frame: Up to Week 24
Average ferritin level
Time frame: Up to Week 24
Average transferrin level
Time frame: Up to Week 24
Average total iron binding capacity level
Time frame: Up to Week 24
Average soluble transferrin receptor level
Time frame: Up to Week 24
Average transferrin saturation level
Time frame: Up to Week 24
Average reticulocyte hemoglobin content level
Time frame: Up to Week 24
Number of hospitalizations
Time frame: Up to Week 24
Duration of hospitalizations
Time frame: Up to Week 24