An Observer-blind, Multi-center, Placebo-controlled, Parallel Group Study to Assess the Safety and Tolerability and to Characterize the Pharmacokinetics and the Pharmacodynamics of Different Doses of BAY1213790 in Patients With End-stage Renal Disease Undergoing Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 55
- 试验地点
- 15
- 主要终点
- Number of major and CRNM bleeding events
研究概览
简要总结
The purpose of this study is to investigate the safety of two different doses of a drug called BAY1213790 and how well it is tolerated in patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD). Approximately 40, with up to 60 study patients will take part in the study.
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
- Double (Participant, Investigator)
盲法说明
Patients, investigators, and all other site staff will remain blinded for the administered BAY1213790 or placebo, with the exception of the unblinded pharmacist or specifically dedicated site personnel.The sponsor will be not be blinded. Bioanalysis of plasma concentrations and PD parameters, as well as the evaluation of results will be performed in a non-blinded fashion.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •High risk for clinically significant bleeding
- •Acute renal failure
- •Planned major surgery in the next 7 months from randomization
- •Concomitant use of oral anticoagulant therapy or antiplatelet therapy
- •Documented thrombotic event in the past 6 months
研究组 & 干预措施
Dose 1 of BAY1213790
Single intravenous infusion BAY1213790 (Dose 1)
干预措施: BAY1213790 (Drug)
Dose 2 of BAY1213790
Single intravenous infusion BAY1213790 (Dose 2)
干预措施: BAY1213790 (Drug)
Placebo
Single intravenous infusion placebo
干预措施: 0.9% sodium chloride solution (Drug)
结局指标
主要结局
Number of major and CRNM bleeding events
时间窗: Approx. 4 weeks (After study drug or placebo administration)
次要结局
- AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)(Approx. 5 months (Pre-dose to follow up))
- aPTT will be measured via the kaolin-trigger method (clotting assay)(Approx. 6 months (Before study drug or placebo administration to follow up))
- Factor XI activity will be assessed with an aPTT-based coagulation test using FXI(Approx. 6 months (Before study drug or placebo administration to follow up))