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.

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 Overview

• Status: Not yet recruiting
• Conditions: Anaemia
• Intervention / Treatment: Drug: Daprodustat; Drug: Darbepoetin alfa

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Shuai He, Project Manager; Phone Number: 0531-55820453; Email: shuai1.he@qilu-pharma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female or male，age 18 to 75
2. Weight 45 to 100 kg
3. Receiving hemodialysis (including hemodiafiltration) consistently three times a week for at least 12 weeks prior to screening.
4. Patients with pre-dialysis Hb levels measured after the maximum interdialytic interval at Scr Visit 1 and Scr Visit 2 (1 week after the start of observation) of ≥95 g/L and <120 g/L and a difference (in absolute value) between Scr Visit 1 and Scr Visit 2 of ≤15 g/L.
5. TSAT >20% and ferritin >100 μg/L
6. Use of one and the same ESA for 10 weeks prior to screening
7. Darbepoetin alfa 10 to 60 μg per week, epoetin (including biosimilars) 1500 to 10000 international units (IU) per week.

Exclusion Criteria:

1. History of bone-marrow hypoplasia, pure red cell aplasia, pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.
2. History of malignancy.
3. Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease OR clinically significant GI bleeding within 12 weeks prior to screening or during a period from screening to Day 1.
4. Myocardial infarction, acute coronary syndrome, stroke, or transient ischemic attack: Diagnosed within 12 weeks prior to screening or during a period from screening to Day 1
5. Chronic Class III or IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.
6. poorly controlled hypertension.
7. Current unstable active liver or biliary disease.
8. History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.
9. Use or planned use of any prescription or non-prescription drugs or dietary supplements that are prohibited during the study period.
10. Use of an investigational agent within 30 days or five half lives of the investigational agent (whichever is longer)
11. Use of daprodustat or other HIF-PHI within 4 weeks prior to screening, or any prior treatment with daprodustat for a treatment duration of > 4weeks.
12. QTc >500 milliseconds (msec); or QTc >530 msec in subjects with bundle branch block.
13. ALT or AST >2 upper limit of normal (ULN)，or bilirubin >1.5×ULN.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Darbepoetin alfa	Drug: Darbepoetin alfa; Subjects will receive IV darbepoetin alfa once weekly for 28 weeks
Experimental: Daprodustat	Drug: Daprodustat; Subjects will receive oral daprodustat once daily for 28 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Hemoglobin (Hgb) During the Efficacy Evaluation Period	The mean hemoglobin during the Evaluation Period was estimated by a statistical model.	Weeks 25 to 28

Collaborators and Investigators

• Sponsor: Qilu Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 10, 2025
• First Posted (Actual): December 23, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia; Amino Acids, Peptides, and Proteins; Proteins; Carbohydrates; Glycoproteins; Glycoconjugates; Colony-Stimulating Factors; Erythropoietin; Darbepoetin alfa; GSK1278863
• Other Study ID Numbers: QLG1218-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No