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

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

What this study is about