NCT03350347已完成3 期
A Randomized, Open-label, Active-controlled, Parallel-group, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Comparison to Darbepoetin Alfa in Non-dialysis Subjects Previously Treated With Erythropoiesis-Stimulating Agents (ESAs)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 164
- 试验地点
- 59
- 主要终点
- Mean Hb (Hemoglobin) level
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with estimated glomerular filtration rate (eGFR)< 60 mL/min/1.73m^2 (Chronic kidney disease [CKD] stages 3 to 5)
- •Have used the same ESA for 8 weeks prior to screening
- •Treated with darbepoetin alfa with bi-weekly or monthly dose, epoetin beta pegol with monthly, OR epoetin alfa/beta weekly or bi-weekly, and having had no more than one dose change within 8 weeks prior to randomization
- •Body weight > 40 and ≤ 160 kg at screening
- •Male or female subject ≥ 20 years of age at screening
- •Not on dialysis and not expected to start dialysis during the study period
- •Mean screening Hb level ≥ 10.0 and < 13.0 g/dL (mean of all central laboratory Hb levels [at least 2 measurements must be taken ≥ 2 days apart] during the 8-week screening period, AND all Hb level must be measured by the central laboratory, AND the difference between the lowest level and highest level is < 1.2 g/dL), with the last screening Hb level measurement within 14 days prior to randomization
- •Ferritin ≥ 100 ng/mL or Transferrin saturation ≥ 20%
排除标准
- •New York Heart Association (NYHA) Class III or IV congestive heart failure
- •History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization
- •Sustained and poorly controlled arterial hypertension (defined as systolic BP (blood pressure)≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP < 90mmHg) at randomization
- •Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)
研究组 & 干预措施
Molidustat (BAY85-3934)
Experimental
Molidustat group
干预措施: Molidustat (BAY85-3934) (Drug)
Darbepoetin alfa
Active Comparator
Darbepoetin alfa group
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Mean Hb (Hemoglobin) level
时间窗: From week 30 to 36
Change in hemoglobin level from baseline to the average during the evaluation period
时间窗: Baseline and week 30 to 36
次要结局
- Responder rate: proportion of responders among the subjects(From week 30 to 36)
- Proportion of subjects who meet each component of the response(From week 30 to 36)
- Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period(From week 30 to 36)
- Hb level(Baseline and up to 52 weeks)
- Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period(From week 30 to 36)
- Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period(From week 30 to 36)
- Proportion of subjects whose hemoglobin levels are in the target range(Up to 52 weeks)
- Proportion of subjects whose hemoglobin levels are below the target range(Up to 52 weeks)
- Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week(Up to 52 weeks)
- Number of participants with serious adverse events(Up to 52 weeks)
- EPO (Erythropoietin) serum concentration of Molidustat(At baseline, week 12, week 24 and week 52)
- Change in Hb level(Baseline and up to 52 weeks)
- Maximum concentration (Cmax) of Molidustat(At baseline, week 12, week 24 and week 52)
- Proportion of subjects whose hemoglobin levels are above the target range(Up to 52 weeks)
- Area under the concentration-time curve (AUC) of Molidustat(At baseline, week 12, week 24 and week 52)
研究者
研究点 (59)
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