End-stage Renal Disease (ESRD) Pilot Study

Bayer

Status and phase: Completed; Phase 1

Conditions: Renal Dialysis

Treatments: Drug: 0.9% sodium chloride solution; Drug: BAY1213790

Study type: Interventional

Funder types: Industry

Identifiers

NCT03787368

2018-003109-24 (EudraCT Number)

20046

Details and patient eligibility

About

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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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55 participants in 3 patient groups, including a placebo group

Dose 1 of BAY1213790

Experimental group

Description:

Single intravenous infusion BAY1213790 (Dose 1)

Treatment:

Drug: BAY1213790

Dose 2 of BAY1213790

Experimental group

Description:

Single intravenous infusion BAY1213790 (Dose 2)

Treatment:

Drug: BAY1213790

Placebo

Placebo Comparator group

Description:

Single intravenous infusion placebo

Treatment:

Drug: 0.9% sodium chloride solution