Factor XI LICA to Reduce Events Such as Heart Attack and Stroke in Patients Whose Kidneys Are no Longer Able to Work as They Should and Require Treatment to Filter Wastes From the Blood: Focus is on the Safety of BAY2976217 and the Way the Body Absorbs, Distributes and Removes the Study Drug
Condition: End Stage Renal Disease Requiring Hemodialysis
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Intervention: Fesomersen sodium (BAY2976217); Placebo
Intervention description: Study intervention will be injected subcutaneously.; Matching placebo to BAY2976217 will be injected subcutaneously.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 307.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: End stage renal disease (ESRD); Hemodialysis (HD); Thrombotic Events

Summary:

      Patients whose kidneys are no longer able to work as they should and require treatment to
      filter wastes from the blood (hemodialysis) are at high risk for blood clots that form in
      blood vessels (thrombosis) blocking blood flow that causes heart attacks, strokes, and other
      life-threatening conditions. BAY2976217 is under clinical development for prevention of
      thrombosis. The goal of the study is to learn more about the safety of BAY2976217, how it is
      tolerated and the way the body absorbs, distributes and gets rid of the study dug given as
      multiple doses in participants with renal impairment who require hemodialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant must be at least 18 years of age at the time of signing the informed
             consent form (ICF)

          -  Participants with ESRD on hemodialysis (HD) for ≥3 months at the time of signing of
             the ICF, receiving dialysis at least 9 hours a week and stable in the view of the
             investigator

          -  Male or female (contraceptive use by men or women should be consistent with local
             regulations regarding the methods of contraception for those participating in clinical
             studies)

          -  Capable of giving signed ICF as described in the Protocol, which includes compliance
             with the requirements and restrictions listed in the ICF and in the protocol

        Exclusion Criteria:

          -  Participants receiving antiplatelet therapy except daily acetylsalicylic acid (ASA) ≤
             150 mg/day

          -  Participants receiving anticoagulation in therapeutic doses, other than standard
             anticoagulation during the hemodialysis procedure

          -  Known inherited bleeding disorder e.g. von-Willebrand disease or Hemophilia A, B or C

          -  Recent (<6 months before screening) clinically significant bleeding, or at high risk
             of bleeding (in the judgement of the investigator)

          -  Recent (<3 months before screening) thromboembolic event, e.g. acute coronary
             syndrome, stroke, or Venous thromboembolism (except dialysis access thrombosis)

          -  Recent (<3 months before screening) major surgery or scheduled major surgery during
             participation in the study

          -  Scheduled living donor renal transplant during study participation

          -  Known Hepatitis B or C

          -  Known HIV with recent documented detectable viral load (<3 months before screening)

          -  Persistent heart failure as classified by the New York Heart Association
             classification of 3 or higher

          -  Life expectancy less than 6 months

          -  Sustained uncontrolled hypertension (persistent measurements of diastolic blood
             pressure ≥ 100 mmHg, and/or systolic blood pressure ≥ 180 mmHg)

          -  Hepatic disease associated with either: coagulopathy leading to a clinically relevant
             bleeding risk, or ALT > 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20%
             of the total

          -  Hb < 9.0 g/dL at screening

          -  Platelet count < 120,000 mm^3 at screening

          -  Known hypersensitivity to the investigational drug or to inactive constituents of the
             study intervention

          -  Active malignancy requiring treatment during study participation (except non-melanoma
             skin cancer, or cervical carcinoma in situ)

          -  Participation in a study with an investigational medicinal product within 30 days or
             within 5 half-lives of the previous administered drug, whichever is longer, prior to
             the screening/observational period (Note: Participants from previous BAY2306001/ISIS
             416858 and BAY2976217/ ION 957943 studies are eligible)

          -  Any other conditions, which, in the opinion of the investigator or Sponsor would make
             the subject unsuitable for inclusion

          -  Confirmed pregnancy