NCT07300111

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

A Randomized, Open Label, Active-controlled, Parallel-group, Multi-center Study to Evaluate Efficacy and Safety of QLG1218(Daprodustat) in Chinese Hemodialysis-dependent Subjects With Anemia Associated With Chronic Kidney Disease.

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Anaemia

Interventions

Type	Name	Description
DRUG	Daprodustat	Subjects will receive oral daprodustat once daily for 28 weeks
DRUG	Darbepoetin alfa	Subjects will receive IV darbepoetin alfa once weekly for 28 weeks

Timeline

• Start date: 2025-12-31
• Primary completion: 2027-05-01
• Completion: 2027-07-01
• First posted: 2025-12-23
• Last updated: 2025-12-23