• Adult males and females ≥ 18 years old.

• Patient (or patient's legally acceptable representative) has voluntarily signed and dated an informed consent form (ICF), approved by an Ethics Committee (EC) or institutional review board (IRB), after the nature of the study has been explained and the patient has had the opportunity to ask questions.

• Patient with stage 5 CKD defined by estimated GFR (eGFR, ≤15 mL/min/1.73m2) on adequate HD for a minimum of 12 weeks prior to Day 1. \*CKD staging will be based on the five-stage system for classification of CKD based on KDIGO guidelines.

• Hemodialysis patients with single-pool Kt/V ≥ 1.2 or urea reduction ratio ≥ 65%.

• \*Single-pool Kt/V or urea reduction ratio will be based on results measured within 4 weeks prior to screening or during the screening period.

• Patients must be on stable doses of IV injections of ESA (including biosimilars) for at least 6 weeks prior to Day 1.

• Minimum ESA dose;

⁃ Epoetin alfa, epoetin beta, and epoetin kappa: ≥1,500 U/week

⁃ Darbepoetin alfa: ≥20 µg/week

⁃ Mircera®: ≥30 µg/2 weeks

• Mean of the 2 most recent local laboratory Hb screening values obtained at least 6 days apart, must be 9.0 g/dL to 12.0 g/dL, inclusive, with a difference of ≤1.5 g/dL between the highest and the lowest value.

• Patients with serum ferritin ≥100 ng/mL at screening.

• Patients with transferrin saturation (TSAT) ≥20% at screening.

• Serum folate concentrations ≥lower limit of normal (LLN) at screening.

⁃ Serum total vitamin B12 concentrations ≥LLN at screening.