Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
Condition: End-stage Renal Disease; Prevention of Thromboembolic Events; Hemodialysis; Hemodiafiltration
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Thromboembolism
Intervention: BAY1213790 (Osocimab); Placebo
Intervention description: Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.; Subcutaneous administration in the same manner as Osocimab.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 704.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: End-stage renal disease (ESRD); Hemodialysis

Summary:

      In this study researchers want to learn about the safety of drug Osocimab at lower-dose and
      higher-doses in adult participants with kidney disease undergoing regular dialysis (a
      procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients
      with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels
      diseases. Osocimab is a human monoclonal antibody under development for the prevention of
      events caused by blood clots like heart attack, stroke and death due to heart or blood
      vessels diseases. It works by binding to and blocking the activated form of clotting factor
      XI which increases the formation and stability of clots. Researchers also want to find out
      how drug Osocimab works in human body and how the body absorbs, distributes and excretes the
      drug.

      Participants in this study will receive monthly injection of either Osocimab at a lower-dose
      or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in
      it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly.
      Observation for each participant will last up to 23 months. Blood samples will be collected
      from the participants to monitor the safety and measure the blood level of the study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be at least 18 years of age

          -  Patients with end-stage renal disease on hemodialysis (including hemodiafiltration)
             for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of
             the investigator

          -  Body weight of at least 50 kg

          -  Male and/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.

        Exclusion Criteria:

          -  Recent (<6 months before screening) clinically significant bleeding

          -  Hemoglobin (Hb) < 9.0 g/dL at screening

          -  Platelet count < 100 x 10^9/L

          -  aPTT or PT > ULN (upper limit of normal)

          -  Hepatic disease associated with ALT > 3x ULN, or total bilirubin >2x ULN with direct
             bilirubin > 20% of the total

          -  Sustained uncontrolled hypertension (diastolic blood pressure ≥100 mmHg and/or
             systolic blood pressure ≥ 180 mmHg)

          -  Known intracranial neoplasm, arteriovenous malformation or aneurysm

          -  Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C

          -  Recent (<3 months before screening) thromboembolic event, e.g. acute coronary
             syndrome, stroke or VTE (except dialysis access thrombosis)

          -  Recent (<3 months before screening) major surgery or scheduled major surgery during
             study participation

          -  Scheduled living donor renal transplant during study participation

          -  Persistent heart failure as classified by the New York Heart Association (NYHA)
             classification of 3 or higher

          -  Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day

          -  Receiving anticoagulation in therapeutic doses, other than standard anticoagulation
             during the hemodialysis procedure