NCT02064426已完成2 期
A Controlled, Parallel Group, Open-label, Multicenter Extension Study to Investigate Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Long-term Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis in the United States and Japan
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 88
- 主要终点
- Change in local laboratory hemoglobin level from baseline
研究概览
简要总结
Evaluate efficacy and safety up to 36 months of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta. Titration will be based on the subject's hemoglobin (Hb) response and tolerability of the prior dose. Planned doses include 15, 25, 50, 75, 100,and 150 mg once daily.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible male or female subjects were previously enrolled in Study 16208, have a diagnosis of anemia associated with CKD, and are on hemodialysis.
- •Men who agree to use adequate contraception when sexually active or women without childbearing potential
- •Participation and completion of treatment in Study 16208; subjects must have received 16 weeks of study medication and completed the end of treatment visit (Day 113) in the parent study
- •Mean Hb concentration of 9.5 to 11.5 g/dL, inclusive, during the evaluation period (i.e., the last 4 weeks of the parent study) when the subject completed 16 weeks of treatment with BAY85-3934, epoetin alfa, or epoetin beta in Study 16208
排除标准
- •A scheduled kidney transplant or any other organ transplant within the next 6 months (being on a waiting list does not exclude the subject)
- •Updates to medical and surgical history which meet the exclusion criteria in the parent study
- •Subjects treated with immunosuppressive therapy and the breast cancer resistant protein (BCRP) substrates, irinotecan, topotecan, methotrexate, imatinib, and lapatinib
- •Sustained, poorly controlled arterial hypertension or hypotension at baseline, defined as mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively
- •Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial fibrillation or flutter, prolonged QT > 500 msec, second or third degree atrioventricular [AV] block)
- •New York Heart Association Class III or IV congestive heart failure
- •Severe hepatic insufficiency (defined as alanine aminotransferase [ALT], aspartate aminotransferase [AST], or gamma-glutamyl transferase > 3 x the upper limit of norma [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator's opinion
- •An ongoing SAE from Study 16208 that is assessed as related to study drug
- •Alcohol or drug abuse
研究组 & 干预措施
Molidustat (BAY85-3934)
Experimental
干预措施: Molidustat (BAY85-3934) (Drug)
Epoetin alfa/beta
Active Comparator
干预措施: Epoetin alfa/beta (Biological)
结局指标
主要结局
Change in local laboratory hemoglobin level from baseline
时间窗: Baseline up to 36 months
Number of participants with serious adverse events as a measure of safety and tolerability
时间窗: Up to 36 months
次要结局
- Change of red blood cell count from baseline of study 16208(Baseline up to 36 months)
- Change of reticulocyte count from baseline of study 16208(Baseline up to 36 months)
- Change of hematocrit from baseline of this study(Baseline up to 36 months)
- Change of hematocrit from baseline of study 16208(Baseline up to 36 months)
- Maintenance in hemoglobin target range (9.5 to 11.5 g/dL)(Up to 36 months)
- Number of subjects requiring titration of dose(Up to 36 months)
- Change of red blood cell count from baseline of this study(Baseline up to 36 months)
- Duration of treatment exposure(Up to 36 months)
- Change of reticulocyte count from baseline of this study(Baseline up to 36 months)
- Change of central laboratory hemoglobin level from baseline of study 16208(Baseline up to 36 months)
- Maintenance in hemoglobin target range (10.0 to 11.0 g/dL)(Up to 36 months)
- Change of central laboratory hemoglobin level from baseline of this study(Baseline up to 36 months)
研究者
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