NCT07300111尚未招募3 期
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.
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Mean Hemoglobin (Hgb) During the Efficacy Evaluation Period
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male，age 18 to 75
- •Weight 45 to 100 kg
- •Receiving hemodialysis (including hemodiafiltration) consistently three times a week for at least 12 weeks prior to screening.
- •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.
- •TSAT >20% and ferritin >100 μg/L
- •Use of one and the same ESA for 10 weeks prior to screening
- •Darbepoetin alfa 10 to 60 μg per week, epoetin (including biosimilars) 1500 to 10000 international units (IU) per week.
排除标准
- •History of bone-marrow hypoplasia, pure red cell aplasia, pernicious anemia, thalassemia, sickle cell anemia, or myelodysplastic syndromes.
- •History of malignancy.
- •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
- •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
- •Chronic Class III or IV heart failure, as defined by the New York Heart Association (NYHA) functional classification system.
- •poorly controlled hypertension.
- •Current unstable active liver or biliary disease.
- •History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product.
- •Use or planned use of any prescription or non-prescription drugs or dietary supplements that are prohibited during the study period.
- •Use of an investigational agent within 30 days or five half lives of the investigational agent (whichever is longer)
- •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.
- •QTc >500 milliseconds (msec); or QTc >530 msec in subjects with bundle branch block.
- •ALT or AST >2 upper limit of normal (ULN)，or bilirubin >1.5×ULN.
研究组 & 干预措施
Daprodustat
Experimental
干预措施: Daprodustat (Drug)
Darbepoetin alfa
Active Comparator
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Mean Hemoglobin (Hgb) During the Efficacy Evaluation Period
时间窗: Weeks 25 to 28
The mean hemoglobin during the Evaluation Period was estimated by a statistical model.
次要结局
未报告次要终点
研究者
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