End-stage Renal Disease (ESRD) Pilot Study

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: September 15, 2021

Interventions

  • Drug: BAY1213790
    • Single intravenous infusion of BAY1213790 (Two different doses)
  • Drug: 0.9% sodium chloride solution
    • Single intravenous infusion of Placebo (0.9% sodium chloride solution)

Arms, Groups and Cohorts

  • Experimental: Dose 1 of BAY1213790
    • Single intravenous infusion BAY1213790 (Dose 1)
  • Experimental: Dose 2 of BAY1213790
    • Single intravenous infusion BAY1213790 (Dose 2)
  • Placebo Comparator: Placebo
    • Single intravenous infusion placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Number of major and CRNM bleeding events
    • Time Frame: Approx. 4 weeks (After study drug or placebo administration)

Secondary Measures

  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor

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