Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis (CONVERT)
- Conditions
- Prevention of Thromboembolic Events in ESRD Patients on Hemodialysis Who Are at Risk for Thromboembolic Events.
- Registration Number
- JPRN-jRCT2080225371
- Lead Sponsor
- Bayer Yakuhin, Ltd.
- Brief Summary
Compared with placebo, osocimab treatment was not associated with an increased risk of bleeding in a broad spectrum of ESRD patients on hemodialysis and was generally safe and well-tolerated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 859
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 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 >= 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method