This study is to evaluate the efficacy and safety of QLG1218(daprodustat) following a switch from erythropoiesis-stimulating agent (ESA) in Chinese HD subjects with renal anemia who are currently treated with ESA. The primary objective is to demonstrate non-inferiority of QLG1218 to darbepoetin alfa. This study is a randomized, open Label, active-controlled, parallel-group, multi-center Study. The total duration of the study will be approximately 32 weeks including screening and follow-up.
Female or male，age 18 to 75
Weight 45 to 100 kg
Receiving hemodialysis (including hemodiafiltration) consistently three times a week for at least 12 weeks prior to screening.
Patients with pre-dialysis Hb levels measured after the maximum interdialytic interval at Scr Visit 1 and Scr Visit 2 (1 week after the start of observation) of ≥95 g/L and <120 g/L and a difference (in absolute value) between Scr Visit 1 and Scr Visit 2 of ≤15 g/L.
History of bone-marrow hypoplasia, pure red cell aplasia, pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.
History of malignancy.
Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding within 12 weeks prior to screening or during a period from screening to Day 1.
Myocardial infarction, acute coronary syndrome, stroke, or transient ischemic attack: Diagnosed within 12 weeks prior to screening or during a period from screening to Day 1
Parallel
Daprodustat
DrugSubjects will receive oral daprodustat once daily for 28 weeks
Darbepoetin alfa
DrugSubjects will receive IV darbepoetin alfa once weekly for 28 weeks
Mean Hemoglobin (Hgb) During the Efficacy Evaluation Period
The mean hemoglobin during the Evaluation Period was estimated by a statistical model.
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