A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients With Anemia

Inclusion Criteria

• •Subjects with renal anemia who have been receiving recombinant human erythropoietin (rHuEPO, two times weekly or three times weekly) or darbepoetin alfa (intravenous treatment) within the doses approved in Japan for more than 8 weeks before the screening assessment
• •Mean of the subject's two most recent Hb values before dialysis after the longest dialysis interval during the Screening Period must be ≥10.0 g/dL and ≤12.0 g/dL
• •Either transferrin saturation (TSAT) ≥ 20% or serum ferritin ≥ 100 ng/mL during the screening period
• •Female subject must either:
• •Be of non-childbearing potential:
• •post-menopausal (defined as at least 1 year without any menses) prior to Screening, or
• •documented surgically sterile Or, if of childbearing potential,
• •Agree not to try to become pregnant during the study and for 28 days after the final study drug administration
• •And have a negative pregnancy test at Screening
• •And, if heterosexually active, agree to consistently use two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and continued for 28 days after the final study drug administration.
• •* Female subject must agree not to breastfeed starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
• •* Female subject must not donate ova starting at Screening and throughout the study period, and continued for 28 days after the final study drug administration.
• •* Male subject and their female spouse/partners who are of childbearing potential must be using two forms of highly effective form of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 12 weeks after the final study drug administration
• •* Male subject must not donate sperm starting at Screening and throughout the study period and, for 12 weeks after the final study drug administration