NCT03351166已完成3 期
A Single Arm, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Dialysis Subjects With Renal Anemia Who Are Not Treated With Erythropoiesis-Stimulating Agents (ESAs)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 25
- 试验地点
- 20
- 主要终点
- Responder rate: proportion of responders among the subjects
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Molidustat in dialysis subjects with renal anemia who are not treated with Erythropoiesis-Stimulating Agents (ESAs)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Subject with end-stage kidney disease (ESKD) on dialysis (including, hemodiafiltration, hemodialysis, and other modalities except for peritoneal dialysis) weekly or more than weekly
- •Body weight > 40 and ≤ 160 kg at screening
- •Male or female subject ≥ 20 years of age at screening
- •At least one kidney
- •Not treated with ESAs and/or HIF-PH inhibitors within 8 weeks prior to randomization. However, in case of the patient washed out from ESAs, when the mean Hb (at least 2 central laboratory measurements must be taken ≥ 2 days apart before dialysis) has decrease to ≥ 0.5 dL from the Hb level (central laboratory measurement, before dialysis) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment was over 1 week for epoetin-alpha, 2 weeks for darbepoetin alpha or 4 weeks for epoetin beta pegol
- •Mean of the last 2 Hb level (central laboratory measurement, before dialysis) during the screening period must be ≥ 8.0 and < 10.0 g/dL (2 measurements must be taken ≥ 2 days apart and the difference between the 2 measurements must be < 1.2 g/dL) with the last screening Hb measurement within 14 days prior to study drug assignment
- •Ferritin ≥ 50 ng/mL at screening
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≥ 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)
结局指标
主要结局
Responder rate: proportion of responders among the subjects
时间窗: Week 21 to 24
Responder is defined as meeting all of the following criteria: (i) Mean of the Hb levels in the target range (ii) ≥ 50% of the Hb levels in the target range (iii) No rescue treatment
Rate of rise in Hb (Hemoglobin) level (g/dL/week)
时间窗: Up to 8 weeks
次要结局
- Hb level(Baseline and up to 24 weeks)
- Proportion of subjects whose mean hemoglobin levels are above the target range during the evaluation period(Week 21 to 24)
- Proportion of subjects whose mean hemoglobin levels are below the target range during the evaluation period(Week 21 to 24)
- Proportion of subjects with hemoglobin levels above the target range(Up to 24 weeks)
- Proportion of subjects with hemoglobin levels below the target range(Up to 24 weeks)
- Proportion of subjects whose mean hemoglobin levels are in the target range during the evaluation period(Week 21 to 24)
- Area under the concentration-time curve (AUC) of Molidustat(Baseline, Week 8, Week16 and Week 24)
- Change in Hb level(Baseline and up to 24 weeks)
- Proportion of subjects who meet each component of the response(Week 21 to 24)
- Cumulative proportion of subjects who achieve the lower limit of the target Hb range at least once at each visit(Up to 24 weeks)
- Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week(Up to 24 weeks)
- Number of participants with serious adverse events(Up to 24 weeks)
- Maximum concentration (Cmax) of Molidustat(Baseline, Week 8, Week16 and Week 24)
- Rate of rise in Hb (Hemoglobin) level (g/dL/week)(Up to 4 weeks)
- Proportion of subjects with hemoglobin levels in the target range(Up to 24 weeks)
- EPO (Erythropoietin) serum concentration of Molidustat(Baseline, Week 8, Week16 and Week 24)
研究者
研究点 (20)
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