Study to investigate the safety of a drug called osocimab at low and high doses in adult patients with kidney failure requiring regular hemodialysis
- Conditions
- Prevention of thromboembolic events in ESRD patients on hemodialysis who are at risk for thromboembolic eventsTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2019-003957-27-IT
- Lead Sponsor
- BAYER AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 704
• 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
• Recent (<6 months before screening) clinically significant bleeding
• Hemoglobin (Hb) < 9.0 g/dL at screening
• Platelet count < 100 x 109/L
• aPTT or PT > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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)<br>• 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 Outcome Measures
Name Time Method Secondary end point(s): • Activated partial thromboplastin time (aPTT) at trough levels measured by the kaolin-trigger method and analyzed as ratio to baseline <br>• 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