This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently.
To evaluate the safety and the dose-response of ASP1517 on Hemoglobin (Hb) correction in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently. Patients will receive ASP1517 three times a week (TIW) for first 6weeks. Patients may have the second-randomization to TIW dosing or once-a-week (QW) dosing at Week 6, 8, 10, 12, 14 or 16 if patients meet the criteria.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
107
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kanto, Japan
Unnamed facility
Kyushu, Japan
Rate of rise in Hb (g/dL/week) at Week 6
Time frame: Baseline and at 6 weeks after dosing
Percentage of cumulative number of responder patients
responder is defined as a Hb ≥10.0 g/dL and an increase in Hb by ≥1.0 g/dL
Time frame: for 28 weeks after dosing
Percentage of visits at which patients maintain Hb between 10.0-12.0 g/dL after achieving Hb ≥10.0 g/dL for each patients
Time frame: for 28 weeks after dosing
Percentage of patients who maintain Hb between 10.0-12.0 g/dL at each visit
Time frame: Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28
Change from baseline in Hb
Time frame: Before and Week-2, -3, -4, -6, -8, -10, -12, -14, -16, -18, -20, -22, -24 and -28
Safety assessed as the incidence of adverse events, vital signs, 12-lead ECGs and lab-tests
Time frame: for 28 weeks after dosing
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Unnamed facility
Shikoku, Japan
Unnamed facility
Tōhoku, Japan