Clinical Research Directory

Key Inclusion Criteria: * Receiving stable hemodialysis (including combination methods such as hemodiafiltration or hemofiltration), peritoneal dialysis for ESKD for a minimum of 16 weeks prior to randomization and determined by the Investigator to be compliant with dialysis treatment prescription. * Patient must have been on IV or SC of an approved ESA under the prescription for at least 6 weeks * The mean of two hemoglobin values during screening must be 9.0-12.0 g/dL. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)\<3× upper limit of normal (ULN) * Transferrin saturation ≥20% or ferritin ≥100 ng/mL at screening test * Serum folate and vitamin B12 ≥ lower limit of normal (LLN) at screening test Key Exclusion Criteria: * Concurrent retinal neovascular lesions requiring treatment * Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis or concurrent autoimmune disease with inflammatory symptoms * History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract or concurrent symptomatic gastroparesis despite being on treatment * Uncontrolled hypertension, defined as patients with hypertension having more than one of three systolic blood pressure \>180 mmHg, or diastolic blood pressure \>110 mmHg during the screening assessment * Concurrent congestive heart failure (New York Heart Association \[NYHA\] Class III or higher) * History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment * Participants with a history of significant liver disease or active liver disease * History of a seizure disorder or any occurrence of seizures in the past * Serum albumin (ALB) \< 2.5 g/dL at screening test * Prior ESA/hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment caused total bilirubin \>1.5xULN, or AST/ALT/ ALP\>3xULN, or serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.) * Any prior functioning organ transplant or a scheduled organ transplantation, or anephric