The objective of this study is to evaluate the safety and efficacy of ASP1517 in ESA-naive hemodialysis chronic kidney disease patients with anemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Oral
Hemoglobin (Hb) Response rate
Hb response is defined as reaching target values for Hb and change of Hb from baseline
Time frame: Up to Week 24
Average Hb level from Week 18 to 24
Time frame: Week 18 to 24
Change from baseline in the average Hb level from Week 18 to 24
Time frame: Baseline and Weeks 18 to 24
Proportion of participants with the target Hb level from Week 18 to 24
Time frame: 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
Time frame: Up to Week 4
Proportion of measurement points with the target Hb level
Time frame: Up to Week 24
Proportion of participants with the target Hb level at each week
Time frame: Up to Week 24
Proportion of participants with 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 levels to each week
Time frame: Baseline and Up to Week 24
Average hematocrit level
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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
...and 37 more locations
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
Quality of life assessed by EQ-5D-5L
EQ-5D-5L: 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 hospitalizations
Time frame: Up to Week 24
Duration of hospitalizations
Time frame: Up to Week 24
Safety assessed by incidence of adverse events
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
Number of participants with abnormal Vital signs and/or adverse events related to treatment
Time frame: Up to Week 24
Safety assessed by standard 12-lead electrocardiogram
Time frame: Up to Week 24
Plasma concentration of unchanged ASP1517
Time frame: Up to Week 24