End-stage Renal Disease (ESRD) Pilot Study

• Status: Completed
• Trial end date: 2021-09-16
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

Criteria

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