A randomized, double-blind, parallel group, placebo-controlled, multi-center study to assess the safety and tolerability of monthly subcutaneous administrations of a low and high dose cohort of Osocimab to ESRD patients on regular hemodialysis.
- Conditions
- thromboembolic eventsthrombosis1002914910014523
- Registration Number
- NL-OMON55066
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
• 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.
• Recent (<6 months before screening) clinically significant bleeding
• Hemoglobin (Hb) < 9.0 g/dL at screening
• Platelet count < 100 x 10^9/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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Outcome Measures:<br /><br>• Composite of major and clinically-relevant non-major bleeding events as<br /><br>assessed by blinded Central Independent Adjudication Committee (CIAC) [ Time<br /><br>Frame: From the first dose at month 1 and up to 6 months ]<br /><br>• Composite of moderate and severe adverse ( AEs) and serious adverse events<br /><br>(SAEs) [ Time Frame: From the first dose at month 1 and up to 6<br /><br>months ]</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Outcome Measures:<br /><br>• Activated partial thromboplastin time (aPTT) at trough levels [ Time Frame:<br /><br>At baseline and after 6 months ]. aPTT will be measured.<br /><br>• Factor XIa (FXIa) activity at trough levels [ Time Frame: At baseline and<br /><br>after 6 months ]. Factor XI activity will be assessed.</p><br>