Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
55 participants
INTERVENTIONAL
2019-01-31
2021-09-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dose 1 of BAY1213790
Single intravenous infusion BAY1213790 (Dose 1)
BAY1213790
Single intravenous infusion of BAY1213790 (Two different doses)
Dose 2 of BAY1213790
Single intravenous infusion BAY1213790 (Dose 2)
BAY1213790
Single intravenous infusion of BAY1213790 (Two different doses)
Placebo
Single intravenous infusion placebo
0.9% sodium chloride solution
Single intravenous infusion of Placebo (0.9% sodium chloride solution)
Interventions
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BAY1213790
Single intravenous infusion of BAY1213790 (Two different doses)
0.9% sodium chloride solution
Single intravenous infusion of Placebo (0.9% sodium chloride solution)
Eligibility Criteria
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Inclusion Criteria
* ESRD on hemodialysis (including hemodiafiltration) for at least 3 months
* Life expectancy of \> 6 months
* Women of non-childbearing potential
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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2018-003109-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20046
Identifier Type: -
Identifier Source: org_study_id
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