The objective of this study is to evaluate the efficacy and safety of ASP1517 in hemodialysis patients with renal anemia whose treatment is converted from an Erythropoieses Stimulating Agent formulation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
164
Oral
Site JP00017
Aichi, Japan
Site JP00005
Fukuoka, Japan
Hemoglobin (Hb) Response Rate from Week 18 to Week 24
Hb response defined as average Hb within the target range
Time frame: Week 18 to 24
Hb Response Rate from Week 46 to Week 52
Time frame: Week 46 to 52
Average Hb from Week 18 to Week 24
Time frame: Week 18 to Week 24
Average Hb from Week 46 to Week 52
Time frame: Week 46 to Week 52
Change from baseline in the average Hb from Week 18 to Week 24
Time frame: Baseline and Weeks 18 to 24
Change from baseline in the average Hb from Week 46 to Week 52
Time frame: Baseline and Weeks 46 to 52
Proportion of participants with Hb values within the target value in each post-dosing time point
Time frame: Up to Week 52
Change from baseline in Hb to each post-dosing time point
Time frame: Baseline and Up to Week 52
Proportion of measurement points with target Hb level from Week 18 to Week 24
Time frame: Week 18 to Week 24
Proportion of measurement points with target Hb level from Week 46 to Week 52
Time frame: Week 46 to Week 52
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
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Site JP00004
Gunma, Japan
Site JP00006
Gunma, Japan
Site JP00018
Hokkaido, Japan
Site JP00019
Hokkaido, Japan
Site JP00021
Hokkaido, Japan
Site JP00023
Hyōgo, Japan
Site JP00008
Ibaraki, Japan
Site JP00020
Ishikawa, Japan
...and 15 more locations
Time frame: Up to Week 4
Average hematocrit level
Time frame: Up to Week 52
Average reticulocyte level
Time frame: Up to Week 52
Average Fe level
Time frame: Up to Week 52
Average ferritin level
Time frame: Up to Week 52
Average transferrin level
Time frame: Up to Week 52
Average total iron binding capacity level
Time frame: Up to Week 52
Average soluble transferrin receptor level
Time frame: Up to Week 52
Average transferrin saturation level
Time frame: Up to Week 52
Average reticulocyte hemoglobin content level
Time frame: Up to Week 52
Quality of life assessed by SF-36
SF-36: Medical Outcomes Study 36-Item Short-Form Health Survey
Time frame: Up to Week 52
Quality of life assessed by EQ-5D
EQ-5D: EuroQol 5 Dimension
Time frame: Up to Week 52
Quality of life assessed by FACT-An
FACT-An: Functional Assessment of Cancer Therapy-Anemia
Time frame: Up to Week 52
Number of hospitalizations
Time frame: Up to Week 52
Safety assessed by incidence of adverse events
Time frame: Up to Week 52
Number of participants with abnormal Vital signs and/or adverse events related to treatment
Vital signs: blood pressure and pulse rate
Time frame: Up to Week 52
Safety assessed by standard 12-lead electrocardiogram
Time frame: Up to Week 52
Number of participants with abnormal Laboratory values and/or adverse events related to treatment
Time frame: Up to Week 52