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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Subjects will receive oral daprodustat once daily for 28 weeks
Subjects 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.
Time frame: Weeks 25 to 28
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