Trial Condition(s):

Renal Dialysis

End-stage renal disease (ESRD) pilot study

Bayer Identifier:

20046

ClinicalTrials.gov Identifier:

NCT03787368

EudraCT Number:

2018-003109-24

Study Completed

Trial Purpose

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.

Inclusion Criteria
No Inclusion Criteria Available
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


- 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 Summary

Enrollment Goal
55
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Osocimab (BAY1213790)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

UZ Brussel

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Completed
 
Locations

CHU de Charleroi Hôpital civil

Lodelinsart, Belgium, 6042

Status
Completed
 
Locations

California Institute of Renal Research - Chula Vista

Chula Vista, United States, 91910

Status
Completed
 
Locations

Research by Design, LLC

Chicago, United States, 60643

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

Hospital Reina Sofía

Córdoba, Spain, 14004

Status
Completed
 
Locations

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
Completed
 
Locations

Hospital Universitario Dr. Peset

Valencia, Spain, 46017

Status
Completed
 
Locations

Renal and Transplant Associates of New England, PC

Springfield, United States, 01107

Status
Completed
 
Locations

Nova Clinical Research, LLC

Bradenton, United States, 34209

Status
Completed
 
Locations

CHLO - Hospital Santa Cruz

Carnaxide, Portugal, 2795-53

Status
Completed
 
Locations

Pluribus Dialise - Cascais (DaVita)

Cascais, Portugal, 2750-663

Status
Completed
 
Locations

CHMT - Hospital Rainha Santa Isabel

Torres Novas, Portugal, 2350-754

Status
Completed
 

Trial Design