This is a phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in anemic patients with End-Stage-Kidney-Disease (ESKD)
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)
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
Parallel
AND017 capsules
DrugAND017 capsules administered orally with a starting dose of 10 mg TIW
ESA
DrugESA injection and dose based on package insert and local practice
Evaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD
The mean Hb levels averaged over Week 23-27
The percentage of responders
Responder is defined as: for participants with baseline Hb ≥ 9.0 g/dL, mean Hb ≥10.0 g/dL and a change from baseline ≥ -1.0 g/dL during Weeks 23-27
Percentage of participants that maintained Hb level over target lower limit
Percentage of participants with mean Hb ≥ 10.0 g/dL averaged over Weeks 5-27
Maintenance of Hb within 10.0-12.0 g/dL after initial achievement ≥10.0 g/dL during the entire study treatment period.
During entire study treatment period, the percentage of participants in which Hb, after first reaching ≥ 10.0 g/dL, is maintained within the target range of 10.0-12.0 g/dL (inclusive)
Incidence of extreme Hb levels of ≥13.0 g/dL or <7.5 g/dL during the entire study treatment period
During the entire study treatment period, the percentage of participants in which Hb is ≥ 13.0 g/dL or \< 7.5 g/dL
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