End-stage Renal Disease (ESRD) Pilot Study

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

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.

Inclusion Criteria

• Male and female patients between 18 and 80 years of age.
• ESRD on hemodialysis (including hemodiafiltration) for at least 3 months
• Life expectancy of > 6 months
• Women of non-childbearing potential

Exclusion Criteria:

• 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