A Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis (HD)-Dependent Subjects With Anemia Associated With Chronic Kidney Disease (CKD)

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.

NCT Number	NCT07300111
Lead Sponsor	Qilu Pharmaceutical Co., Ltd.
Conditions	Anaemia
Enrollment	100 participants
Start Date	2025-12-31
Primary Completion	2027-05 (estimated)
Study Completion	2027-07 (estimated)
Updated on ClinicalTrials.gov	2025-12-23