MedDataX Logo

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

NCT ID: NCT07300111

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anaemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Daprodustat

Group Type EXPERIMENTAL

Daprodustat

Intervention Type DRUG

Subjects will receive oral daprodustat once daily for 28 weeks

Darbepoetin alfa

Group Type ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type DRUG

Subjects will receive IV darbepoetin alfa once weekly for 28 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Daprodustat

Subjects will receive oral daprodustat once daily for 28 weeks

Intervention Type DRUG

Darbepoetin alfa

Subjects will receive IV darbepoetin alfa once weekly for 28 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shuai He, Project Manager

Role: CONTACT

Phone: 0531-55820453

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

QLG1218-301

Identifier Type: -

Identifier Source: org_study_id