Factor XI LICA to reduce thrombotic 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 gets rid of the study drug given as multiple doses

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-HU
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-31
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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 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)
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified