Trials / Completed
CompletedNCT03787368
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAY1213790 | Single intravenous infusion of BAY1213790 (Two different doses) |
| DRUG | 0.9% sodium chloride solution | Single intravenous infusion of Placebo (0.9% sodium chloride solution) |
Timeline
- Start date
- 2019-01-31
- Primary completion
- 2021-09-15
- Completion
- 2021-09-15
- First posted
- 2018-12-26
- Last updated
- 2022-03-16
Locations
15 sites across 4 countries: United States, Belgium, Portugal, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03787368. Inclusion in this directory is not an endorsement.