clinical 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)
Qilu Pharmaceutical Co., Ltd.·phase3·not yet recruiting·n = 100
AnaemiaDaprodustatDarbepoetin alfa
brief 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.
started
Dec 31, 2025
primary completion
May 1, 2027
completion
Jul 1, 2027
last updated
Dec 23, 2025
official title
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.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol