End-stage Renal Disease (ESRD) Pilot Study



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 80
Updated:3/8/2019
Start Date:January 31, 2019
End Date:April 29, 2020
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+)1-888-84 22937

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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

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

- 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
We found this trial at
9
sites
Middlebury, Connecticut 06762
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825 South 8th Street
Minneapolis, Minnesota 55404
888-345-2567
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Minneapolis, MN
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9730 South Western Avenue
Chicago, Illinois 60643
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Chicago, IL
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Chula Vista, California 91910
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Chula Vista, CA
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El Paso, Texas 79902
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El Paso, TX
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Houston, Texas 77004
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Houston, TX
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Lauderhill, Florida 33319
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Lauderhill, FL
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Lodelinsart, Hainaut
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San Antonio, Texas 78229
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San Antonio, TX
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