The objective of this study is to evaluate the efficacy and safety of ASP1517 when converted from recombinant human erythropoietin (rHuEPO) or darbepoetin alfa (DA), compared to DA in the treatment of anemia in non-dialysis chronic kidney disease patients. Another uncontrolled cohort will be included to evaluate the efficacy and safety of ASP1517 in patients converted from epoetin beta pegol (CERA). This study will also assess the safety/efficacy of long term treatment of ASP1517 (52 weeks).
This study consists of the following three cohorts. Cohort 1; subjects converted from rHuEPO or DA to ASP1517, Cohort 2; subjects converted from rHuEPO or DA to DA, Cohort 3; subjects converted from epoetin beta pegol (CERA) to ASP1517. In Cohort 1 and 3, ASP1517 will be administered orally for 52 weeks. In Cohort 2, DA will be administered subcutaneously for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
334
Oral administration
Subcutaneous administration
Change from baseline in the average Hemoglobin (Hb)
Time frame: Baseline and Weeks 18 to 24
Average Hb from Week 18 to Week 24
Time frame: 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
Time frame: Weeks 18 to 24
Number of participants who achieve the target Hb level at each week
Time frame: Up to Week 24
Change from baseline in Hb to each post-dosing time point
Time frame: Baseline and Up to Week 52
Proportion of time points that achieve the target Hb level from Weeks 18 to 24
Time frame: 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
Time frame: Up to Week 4
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-5L
EQ-5D: EuroQol 5 Dimension 5 Levels
Time frame: Up to Week 52
Quality of life assessed by WPAI:ANS
WPAI:ANS: Work Productivity and Activity Impairment Questionnaire: Anaemic Symptoms
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Site JP00009
Kasugai, Aichi-ken, Japan
Site JP00030
Nagoya, Aichi-ken, Japan
Site JP00051
Nagoya, Aichi-ken, Japan
Site JP00021
Toyohashi, Aichi-ken, Japan
Site JP00003
Sakura, Chiba, Japan
Site JP00038
Matsuyama, Ehime, Japan
Site JP00044
Matsuyama, Ehime, Japan
Site JP00008
Kitakyushu, Fukuoka, Japan
Site JP00013
Kitakyushu, Fukuoka, Japan
Site JP00040
Kitakyushu, Fukuoka, Japan
...and 56 more locations
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
Average Hb from weeks 44 to 52
Time frame: Up to Week 52
Change from baseline in the average Hb from weeks 44 to 52
Time frame: 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
Time frame: Weeks 44 to 52
Number of participants who achieve the target Hb level at each week
Time frame: Up to Week 52
Proportion of time points that achieve the target Hb level from Weeks 44 to 52
Time frame: Up to Week 52
Average Hematocrit Level
Time frame: Up to Week 52
Average Reticulocyte Level
Time frame: Up to Week 52
Average Ferrum 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 Soluble Transferrin Level
Time frame: Up to Week 52
Average Reticulocyte Hemoglobin Content Level
Time frame: Up to Week 52
Number of Occurence of Hospitalizations
Time frame: Up to Week 52
Duration of Hospitalization
Time frame: Up to week 52
Number of participants with abnormal Vital signs and/or adverse events related to treatment
Time frame: Up to Week 52
Safety assessed by body weight
Time frame: Up to Week 52
Safety assessed by incidence of adverse events
Time frame: Up to Week 52
Safety assessed by standard 12-lead electrocardiogram
Time frame: Up to Week 52
Safety assessed by ophthalmological examination: Fundoscopy
Time frame: Up to Week 24
Safety assessed by ophthalmological examination: optical coherence tomography
Time frame: Up to Week 24
Safety assessed by ophthalmological examination: visual acuity
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 52
Plasma concentration of unchanged ASP1517
Time frame: Up to Week 24