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Completed

NCT Number: NCT03787368

End-stage Renal Disease (ESRD) Pilot Study

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.

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Key information

Conditions

Renal Dialysis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de Charleroi Hôpital civil, Lodelinsart, Hainaut, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY1213790

Drug

Single intravenous infusion of BAY1213790 (Two different doses)

0.9% sodium chloride solution

Drug

Single intravenous infusion of Placebo (0.9% sodium chloride solution)

Primary outcomes

  1. Number of major and CRNM bleeding events

    Time frame: Approx. 4 weeks (Before study drug or placebo administration)

    CRNM bleeding: Clinically Relevant Non-Major bleeding

  2. Number of major and CRNM bleeding events

    Time frame: Approx. 4 weeks (After study drug or placebo administration)

Secondary outcomes

  1. AUC (AUC(0-tlast) will be used as main parameter if mean AUC(tlast-∞) >20% of AUC)

    Time frame: Approx. 5 months (Pre-dose to follow up)

    AUC: Area under the concentration vs. time curve from zero to infinity after single (first) dose

  2. aPTT will be measured via the kaolin-trigger method (clotting assay)

    Time frame: Approx. 6 months (Before study drug or placebo administration to follow up)

    aPTT: activated Partial Thromboplastin Time

  3. Factor XI activity will be assessed with an aPTT-based coagulation test using FXI

    Time frame: Approx. 6 months (Before study drug or placebo administration to follow up)

    FXI: Factor XI

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 26, 2018
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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