Prevention of thromboembolic events in ESRD patients on hemodialysis who are at risk for thromboembolic events MedDRA version: 21.1 Level: LLT Classification code 10049910 Term: Thromboembolism prophylaxis System Organ Class: 100000004865 MedDRA version: 21.1 Level: LLT Classification code 10066622 Term: Chronic hemodialysis System Organ Class: 100000004865 MedDRA version: 21.0 Level: PT Classification code 10077512 Term: End stage renal disease System Organ Class: 10038359 - Renal and urinar
Conditions
Sponsors
Bayer AG
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. 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 435 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 315
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 =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To clinically assess the safety of different doses of osocimab administered subcutaneously once a month as compared to placebo;Secondary Objective: To assess the change of key pharmacodynamic parameter from baseline;Primary end point(s): • Composite of major and clinically-relevant non-major bleeding events (in alignment with ISTH guidelines), as assessed by blinded Central Independent Adjudication Committee (CIAC) • Composite of moderate and severe AEs and SAEs;Timepoint(s) of evaluation of this end point: From the first dose at month 1 and up to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Activated partial thromboplastin time (aPTT) at trough levels measured by the kaolin-trigger method and analyzed as ratio to baseline • Factor XIa (FXIa) activity at trough levels assessed with an aPTT-based coagulation test using FXI deficient plasma and analyzed as ratio to baseline;Timepoint(s) of evaluation of this end point: At baseline and after 6 months | — |
Countries
Austria, Belgium, Bulgaria, China, Czech Republic, France, Greece, Hungary, Israel, Italy, Japan, Lithuania, Netherlands, Poland, Portugal, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed