NCT03418168已完成3 期
An Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral Molidustat in Peritoneal Dialysis Subjects With Renal Anemia
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
- 51
- 试验地点
- 27
- 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 peritoneal dialysis subjects with renal anemia
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 peritoneal dialysis prior to assignment and not expected to start maintenance dialysis (e.g., hemodialysis, hemodiafiltration) other than peritoneal dialysis during the study period
- •Body weight > 40 and ≤ 160 kg at screening
- •Male or female subject ≥ 20 years of age at screening
- •At least one kidney
- •Subjects who meet one of the 1 or 2 following criteria
- •Subjects untreated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be ≥ 8.0 and < 11.0 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
- •Subjects pre treated with ESA at assignment: Mean of the last 2 Hb level (central laboratory measurement) during the screening period must be ≥ 10.0 and < 13.0 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
- •Subjects who meet one of the 1 or 2 following criteria
- •Subjects untreated with ESA at assignment: Subject with ESKD on peritoneal dialysis for at least 2 weeks prior to assignment. AND. Subject not received ESA for 8 weeks prior to assignment. OR. In case of the patient washed out from ESAs, when mean of the last 2 Hb level (at least 2 central laboratory measurements must be taken ≥ 2 days apart) has decrease to ≥ 0.5g/dL from the Hb level (central laboratory measurement) after the last ESA administration, AND the interval from the last ESA administration to the study drug assignment should be over 2 week for epoetin-alpha/beta, 4 weeks for darbepoetin alpha or epoetin beta pegol
- •Subjects pre treated with ESA at assignment:
- •Subject with ESKD on peritoneal dialysis for at least 12 weeks prior to assignment
- •Subject treated with ESA by IV or SC within 8 weeks prior to assignment
- •Treated with 2 or 4 weekly dose of darbepoetin alfa, 4 weekly dose of epoetin beta pegol, OR 3 times per week, twice per week, weekly or bi-weekly dose of epoetin alfa/beta, and having had no more than one dose change within 8 weeks prior to assignment
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 30 to 36
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
次要结局
- Proportion of subjects with mean hemoglobin levels are in the target range(Week 30 to 36)
- Proportion of subjects with hemoglobin levels in the target range(Up to 36 weeks)
- Percentage of days in the target Hb range during the evaluation period(Week 30 to 36)
- Mean Hb (Hemoglobin) level(Week 30 to 36)
- Rate of rise in Hb (Hemoglobin) level (g/dL/week)(Up to 4 weeks)
- Change in Hb level(Baseline and Up to Week 36)
- Change in mean Hb level(Baseline and Week 30 to 36)
- Proportion of subjects who meet each component of the response(Week 30 to 36)
- Proportion of subjects with mean hemoglobin levels are below the target range(Week 30 to 36)
- Proportion of subjects whose maximum rise in Hb between each consecutive visits is above 0.5 g/dL/week(Up to 36 weeks)
- Proportion of subjects whose Hb level was ≥ 13.0 g/dL or < 8.0 g/dL(Up to 36 weeks)
- Proportion of subjects with hemoglobin levels above the target range(Up to 36 weeks)
- Proportion of subjects with mean hemoglobin levels are above the target range(Week 30 to 36)
- Proportion of subjects with hemoglobin levels below the target range(Up to 36 weeks)
- Percentage of Hb levels in target range during the evaluation period(Week 30 to 36)
- Percentage of days in the target Hb range during the treatment period(Up to 36 weeks)
- Number of participants with serious adverse events(Up to 36 weeks)
- Percentage of Hb levels in target range during the treatment period(Up to 36 weeks)
- Proportion of subjects who received at least one rescue treatment(Up to 36 weeks)
- EPO (Erythropoietin) serum concentration of Molidustat(Baseline, Week 8, Wee16 and Week 36)
- Rate of rise in Hb level (g/dL/week) between each consecutive visits(Up to 36 weeks)
- Maximum concentration (Cmax) of Molidustat(Baseline, Week 8, Wee16 and Week 36)
- Area under the concentration-time curve (AUC) of Molidustat(Baseline, Week 8, Wee16 and Week 36)
- Hb level(Baseline and Up to Week 36)
研究者
研究点 (27)
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