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drugset / Trial / 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)

NCT07300111 ↗

Phase 3 Not yet recruiting 100 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-12-31
Primary completion
2027-05
Completion
2027-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Daprodustat Small molecule — Oral
Comparator Darbepoetin alfa Protein / enzyme biologic — Intravenous

Indications

anemia