Inclusion Criteria:
Serum concentration of erythropoietin (EPO): <50 mIU/mL at screening test 1, 2, or 3
Transferrin saturation ≥ 20% or ferritin ≥ 100 ng/mL at screening test 1
Subjects meeting any of the following criteria
- Subjects who has not used erythropoiesis-stimulating agent (ESA) ≥ eight weeks from screening test 1
- Subjects who has used ESA, other than epoetin beta pegol, ≥ four weeks from screening test 1 and has met all of the following criteria A) to C).
A)The total ESA dosage for each week could be changed within a range of 50%, compared to the total ESA dosage for one week before screening test 1, for four weeks before screening test 1 B)Acceptable to discontinue ESA the day following screening test 1 to Follow-up 2 C)The fluctuating range of Hb concentration between screening tests 1 and 2 is within ±0.5 g/dL per week (the same criteria applied between screening test 2 and 3)
- Subjects who receive an explanation about the study before participating in the study and can understand the contents and are willing and able to provide written consent.
<Criteria for ND subjects>
- CKD subjects who never received dialysis and do not need to receive dialysis during the study period.
- Subjects with an Hb concentration at screening test 1 (ESA present at screening test 2) ≥ 10.0 g/dL to < 13.0 g/dL.
- Subjects with an eGFR at screening test 1 ≥ 15 mL/min/1.73m^2 to < 45 mL/min/1.73m^2.
<Criteria for HD subjects>
- Subjects who received hemodialysis (including diafiltration) three times per week ≥ 12 weeks from acquisition consent.
- Subjects with an Hb concentration at screening test 1 (ESA present at screening test 2) ≥ 10.0 g/dL to < 12.0 g/dL.
Exclusion Criteria:
- Subjects with anemia other than that caused by CKD.
- Subjects who have severe infection, systemic hematopathy (e.g. myelodysplastic syndrome, hemoglobinopathy), peptic ulcer or clear hemorrhagic lesion such as gastrointestinal hemorrhage
- Subjects with immune disorder with severe inflammation
- Subjects with uncontrolled secondary hyperparathyroidism
- Subjects who already had or will have a kidney transplantation
- Subjects who have a complication which requires treatment such as proliferative retinopathy, macular edema, or macular degeneration. Or, subjects who had a complication which required treatment such as proliferative retinopathy, macular edema, or macular degeneration within 12 months from screening test 1
- Subjects with congestive heart failure
- Subjects with a medical history of thrombotic disease in the six months from screening test 1
- Subjects with uncontrolled blood pressure; SBP > 170 mmHg or DBP > 100 mmHg at screening test 1 (ESA present, screening tests 1 and 2), (HD subject, evaluated before dialysis)