Factor XI LICA to reduce events such as heart attack and stroke in patientswhose kidneys are no longer able to work as they should and requiretreatment to filter wastes from the blood: Focus is on the safety ofBAY2976217 and the way the body absorbs, distributes and removes thestudy drug

Phase 1

Conditions: End Stage Renal Disease requiring hemodialysis
MedDRA version: 21.0Level: PTClassification code 10077512Term: End stage renal diseaseSystem Organ Class: 10038359 - Renal and urinary disorders
MedDRA version: 21.1Level: LLTClassification code 10019480Term: HemodialysisSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 21.1Level: LLTClassification code 10066639Term: Myocardial infarct prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 20.0Level: PTClassification code 10049165Term: Cerebrovascular accident prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Not possible to specify

Registration Number: EUCTR2019-003927-39-DE

Lead Sponsor: Bayer AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 340

Inclusion Criteria

- Participant must be at least 18 years of age at the time of signing the ICF.
- Participants with ESRD on 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 187
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 153

Exclusion Criteria

- Participants receiving antiplatelet therapy except daily 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 VTE (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 mm3 at screening
- Known hypersensitivity to the investigational drug or to inactive constituents of the study intervention
- Active malignancy requiring treatment during study participation (except nonmelanoma 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 BAY 2306001/ISIS 416858 and BAY 2976217 / 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety of BAY2976217 compared to placebo;Secondary Objective: To evaluate the PK and PD of BAY2976217;Primary end point(s): Incidence of major bleeding and clinically-relevant non-major bleeding during the main treatment period and within the on-treatment time window, as assessed by blinded Central Independent Adjudication Committee (CIAC);Timepoint(s) of evaluation of this end point: Up to 24 weeks

Secondary Outcome Measures

Name	Time	Method

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