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
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
Clareo Health | A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
