Status:
COMPLETED
End-stage Renal Disease (ESRD) Pilot Study
Lead Sponsor:
Bayer
Conditions:
Renal Dialysis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 hemodi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2021
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03787368
Start Date
January 31 2019
End Date
September 15 2021
Last Update
March 16 2022
Active Locations (15)
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1
California Institute of Renal Research - Chula Vista
Chula Vista, California, United States, 91910
2
Nova Clinical Research, LLC
Bradenton, Florida, United States, 34209
3
Research by Design, LLC
Chicago, Illinois, United States, 60643
4
Renal and Transplant Associates of New England, PC
Springfield, Massachusetts, United States, 01107