Prevention of Thromboembolic Events in ESRD Patients on Hemodialysis Who Are at Risk for Thromboembolic Events.
Conditions
Interventions
investigational material(s)
Generic name etc : BAY 1213790
INN of investigational material : osocimab
Therapeutic category code : 333 Anticoagulants
Dosage and Administration for Investigational mater
Sponsors
Bayer Yakuhin, Ltd.
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: - Recent ( 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 >= 00 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety 1. Composite of major and clinically-relevant non-major bleeding events as assessed by blinded Central Independent Adjudication Committee (CIAC) [ Time Frame: From the first dose at month 1 and up to 6 months ] 2. Composite of moderate and severe adverse ( AEs) and serious adverse events (SAEs) [ Time Frame: From the first dose at month 1 and up to 6 months ] | — |
Secondary
| Measure | Time frame |
|---|---|
| exploratory 1. Activated partial thromboplastin time (aPTT) at trough levels [ Time Frame: At baseline and after 6 months ] aPTT will be measured via the kaolin-trigger method (clotting assay) 2. Factor XIa (FXIa) activity at trough levels [ Time Frame: At baseline and after 6 months ] Factor XI activity will be assessed with an aPTT-based coagulation test using FXI deficient plasma | — |
Countries
Asia except Japan, Europe, Japan, North America
Contacts
Public Contactcontact Dedicated
Bayer Yakuhin, Ltd.
Outcome results
None listed