End-stage Renal Disease (ESRD) Pilot Study

  • STATUS
    Recruiting
  • End date
    Aug 13, 2021
  • participants needed
    50
  • sponsor
    Bayer
Updated on 27 January 2021
renal failure
hemodiafiltration
nephropathy

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.

Details
Condition Hemodialysis
Treatment BAY1213790, 0.9% sodium chloride solution
Clinical Study IdentifierNCT03787368
SponsorBayer
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Hemodialysis?
Do you have any of these conditions: Do you have Hemodialysis??
Do you have any of these conditions: Do you have Hemodialysis??
Do you have any of these conditions: Do you have Hemodialysis??
Do you have any of these conditions: Do you have Hemodialysis??
Do you have any of these conditions: Do you have Hemodialysis??
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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