A Study of Intermittent Oral Dosing of ASP1517 in ESA-untreated Chronic Kidney Disease Patients With Anemia

Inclusion Criteria

• •Subjects who were diagnosed with non-dialysis chronic kidney disease (CKD) and who are considered not to require renal replacement therapy during the study period
• •Mean of the subject's two most recent Hb values before randomization during the Screening Period must be \<10.5 g/dL with an absolute difference ≤1.3 g/dL between the two values
• •Either transferrin saturation ≥ 5% or serum ferritin ≥ 30 ng/mL
• •Female subject must either:
• •Be of non-childbearing potential:
• •post-menopausal prior to pre-screening, or
• •documented surgically sterile Or, if of childbearing potential,
• •Agree not to try to become pregnant during the study after informed consent acquisition and for 28 days after the final study drug administration
• •And have a negative urine pregnancy test at pre-screening
• •And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at pre-screening and throughout the study period and for 28 days after the final study drug administration.
• •Female subject must agree not to breastfeed starting at pre-screening and throughout the study period, and for 28 days after the final study drug administration.
• •Female subject must not donate ova starting at pre-screening and throughout the study period, and 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 birth control (at least one of which must be a barrier method) starting at pre-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 pre-screening and throughout the study period, and for 12 weeks after the final study drug administration