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

Status and phase: Not yet enrolling; Phase 3

Conditions: Anaemia

Treatments: Drug: Darbepoetin alfa; Drug: Daprodustat

Study type: Interventional

Funder types: Industry

Identifiers

NCT07300111

QLG1218-301

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Daprodustat

Experimental group

Treatment:

Drug: Daprodustat

Darbepoetin alfa

Active Comparator group

Treatment:

Drug: Darbepoetin alfa