Maintenance Treatment of Anemia Associated With Chronic Kidney Disease (CKD) in Hemodialysis Subjects on Epoetin Alfa / Beta Treatment Versus BAY85-3934 (DIALOGUE4)
2019年9月17日 更新者：Bayer
A Randomized, Parallel Group, Open-label, Multicenter Study to Investigate the Efficacy and Safety of Oral BAY85-3934 and Active Comparator (Epoetin Alfa / Beta) in the Maintenance Treatment of Subjects With Anemia Associated With Chronic Kidney Disease Who Are on Dialysis and on Treatment With an Erythropoiesis-stimulating Agent in the United States and Japan
Evaluate efficacy and safety of 16 weeks of titrated dose treatment with BAY85-3934 versus epoetin alfa/beta as measured by hemoglobin (Hb) levels.
Fixed starting doses of 25, 50,75 and 150 mg of BAY85-3934 titrated at the scheduled dose control visits.
Titration will be based on the subject's Hb response and tolerability of the prior dose.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg/day
研究概览
研究类型
介入性
注册 (实际的)
201
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Kyoto、日本、607-8116
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Nagano、日本、388-8004
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Hokkaido
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Muroran、Hokkaido、日本、050-0083
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Hyogo
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Himeji、Hyogo、日本、670-0947
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Mie
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Kuwana、Mie、日本、511-0061
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California
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Azusa、California、美国、91702
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Long Beach、California、美国、90813
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Los Angeles、California、美国、90025
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Lynwood、California、美国、90262
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Northridge、California、美国、91324
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San Dimas、California、美国、91773
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Whittier、California、美国、90606
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Whittier、California、美国、90602
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Florida
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New Port Richey、Florida、美国、34652
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Pembroke Pines、Florida、美国、33028
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Michigan
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Detroit、Michigan、美国、48236
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Detroit、Michigan、美国、48202
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Missouri
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Creve Coeur、Missouri、美国、63141
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New Jersey
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Eatontown、New Jersey、美国、07724
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New York
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Brooklyn、New York、美国、11212
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Buffalo、New York、美国、14215
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Fresh Meadows、New York、美国、11365
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Ohio
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Cincinnati、Ohio、美国、45206
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Toledo、Ohio、美国、43615
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Oklahoma
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Oklahoma City、Oklahoma、美国、73116
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Tennessee
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Nashville、Tennessee、美国、37212-8150
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Texas
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Fort Worth、Texas、美国、76104
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Fort Worth、Texas、美国、76105
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Fort Worth、Texas、美国、76164
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Grand Prairie、Texas、美国、75050
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Houston、Texas、美国、77004
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Houston、Texas、美国、77091
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Mansfield、Texas、美国、76063
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San Antonio、Texas、美国、78229
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San Antonio、Texas、美国、78215
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- - Eligible subjects will have a diagnosis of anemia associated with CKD(chronic kidney disease).
- Women without childbearing potential
- Male or female subject ≥ 18 years of age with anemia of CKD at screening
- On dialysis, defined as regular long-term hemodialysis, with the same modality of dialysis for ≥ 3 months before randomization
- Dialysis vascular access via native arteriovenous fistula, synthetic graft, long-term catheters, or long-term tunneled catheters
- Treated with epoetin alfa (US or Japan) or epoetin beta (Japan) via intravenous (IV) or subcutaneous (SC) route, on stable dosing defined as a < 50% change from the maximum prescribed weekly dose with no change in the prescribed frequency during the last 8 weeks prior to randomization
- At least one kidney
- Mean screening Hb concentration 9.0 to 11.5 g/dL inclusive (mean of all local laboratory Hb measurements [at least 2 measurements must be taken ≥ 2 days apart] during the 4 week screening period, AND none of the measurements can be < 9.0 g/dL or > 12.0 g /dL
- Serum ferritin levels ≥ 100 μg/L OR transferrin saturation ≥ 20% at screening. Iron substitution is allowed
- Folate and vitamin B12 levels above the lower limit of normal. Supplementation is allowed
- Exclusion Criteria:
- Subjects with significant acute or chronic bleeding, such as overt gastrointestinal bleeding
- Hereditary hemoglobinopathies (including, but not limited to, sickle cell disease, beta thalassemia, and thalassemia major) which may be the primary cause of anemia
- Chronic lymphoproliferative diseases
- Any allograft (including renal allograft) in place and on immunosuppressive therapy, or a scheduled kidney transplant within the next 16 weeks (being on a waiting list does not exclude the subject)
- Chronic inflammatory disease that could impact erythropoiesis (e.g., systemic lupus erythematosis, rheumatoid arthritis, celiac disease)
- Subjects treated with immuno- or myelosuppressive therapy within 8 weeks prior to randomization: e.g., everolimus, sirolimus, rituximab, azathioprine, mycophenolate mofetil, mycophenolic acid, cyclosporine,methotrexate, and tacrolimus, chemotherapeutic agents and other anticancer agents, and systemic steroids (except inhaled steroids) for 7 days
- RBC-containing transfusion within 8 weeks before randomization
- History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, transient ischemic attack, deep vein thrombosis, pulmonary embolism) within the last 6 months from the initial screening visit
- Sustained, poorly controlled arterial hypertension or hypotension at screening, defined as a mean BP ≥ 180/110 mmHg or systolic BP < 95 mmHg, respectively
- Severe rhythm or conduction disorder (e.g., HR < 50 or > 110 bpm, atrial flutter, prolonged QT >500 msec, second or third degree atrioventricular [AV]block if not treated with a pacemaker)
- 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 times the upper limit of normal [ULN], total bilirubin > 2 mg/dL, or Child-Pugh B or C) or active hepatitis in the investigator's opinion
- A scheduled surgery that may be expected to lead to significant blood loss
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Molidustat (BAY 85-3934)(25mg)
Starting dose of 25 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits.
Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
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Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
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实验性的：Molidustat (BAY 85-3934)(50mg)
Starting dose of 50 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.
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Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
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实验性的：Molidustat (BAY 85-3934) (75mg)
Starting dose of 75 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100,150 and 200 mg once daily.,
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Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
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实验性的：Molidustat (BAY 85-3934) (150mg)
Starting dose of 150 mg of BAY85-3934 as once-daily oral tablets.
Regular titrations at dose control visits Titration occuring every 4-weeks will be based on the subject's Hb response and tolerability of the prior dose.
Total treatment time is 16 weeks.
Planned doses include 15, 25, 50, 75, 100, 150 and 200 mg once daily
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Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
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有源比较器：Epoetin alfa/beta
Starting dose at the subject's current weekly dose.
Administered IV or SC 3 times per week.
Doses will be titrated at the scheduled dose control visits according to the local label.
Titration will be based on the subject's Hb response and tolerability of the prior dose.
Epoetin alfa may be administered in either the United States (US) or Japan; epoetin beta will only be administered in Japan.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Change in local laboratory hemoglobin level from baseline to the average during the last 4 weeks treatment period
大体时间：Baseline and weeks 14 to 17
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Baseline and weeks 14 to 17
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Duration of exposure on each dose level
大体时间：Up to 16 weeks
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Up to 16 weeks
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Number of subjects requiring titration of dose
大体时间：Up to 16 weeks
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Up to 16 weeks
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Number of participants with serious adverse events as a measure of safety and tolerability
大体时间：Up to 16 weeks
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Up to 16 weeks
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Mean of the hemoglobin (Hb) levels in the target range (10.0 to 11.0 g/dL)
大体时间：From week 14 to 17
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From week 14 to 17
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Mean of the hemoglobin levels in the target range (9.5 to 11.5 g/dL)
大体时间：From week 14 to 17
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From week 14 to 17
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Change from baseline in Hb during active treatment
大体时间：Baseline and weeks 14 to 17
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Baseline and weeks 14 to 17
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Number of patients with hemoglobin levels outside the target range
大体时间：From week 14 to 17
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From week 14 to 17
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Dose level in the evaluation period
大体时间：Up to 16 weeks
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Up to 16 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2013年10月28日
初级完成 (实际的)
2015年10月23日
研究完成 (实际的)
2015年12月15日
研究注册日期
首次提交
2013年10月18日
首先提交符合 QC 标准的
2013年10月29日
首次发布 (估计)
2013年11月5日
研究记录更新
最后更新发布 (实际的)
2019年9月20日
上次提交的符合 QC 标准的更新
2019年9月17日
最后验证
2019年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.