End-stage Renal Disease (ESRD) Pilot Study
Completed · Phase 1 · Has a placebo group
Conditions studied: Renal Dialysis
In brief
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.
Key facts
- Study ID
- NCT03787368
- Run by
- Bayer
- People needed
- 55
- Starts
- 2019-01-31
- Expected to finish
- 2021-09-15
- Last updated by the study team
- 2022-03-16
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- California Institute of Renal Research - Chula Vista — Chula Vista, California, United States
- Nova Clinical Research, LLC — Bradenton, Florida, United States
- Research by Design, LLC — Chicago, Illinois, United States
- Renal and Transplant Associates of New England, PC — Springfield, Massachusetts, United States
- CHU de Charleroi Hôpital civil — Lodelinsart, Hainaut, Belgium
- UZ Brussel — Bruxelles - Brussel, Belgium
- UZ Leuven Gasthuisberg — Leuven, Belgium
- CHLO - Hospital Santa Cruz — Carnaxide, Lisbon District, Portugal
- Pluribus Dialise - Cascais (DaVita) — Cascais, Lisbon District, Portugal
- CHMT - Hospital Rainha Santa Isabel — Torres Novas, Santarém District, Portugal
- Hospital Clínico Universitario de Santiago de Compostela — Santiago de Compostela, A Coruña, Spain
- Ciutat Sanitària i Universitària de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain
- Hospital Reina Sofía — Córdoba, Spain
- Hospital Clínico Universitario de Valencia — Valencia, Spain
- Hospital Universitario Dr. Peset — Valencia, Spain
Full record on ClinicalTrials.gov
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