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)

JRCT ID: jRCT2080225371

Registered date:31/08/2020

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Prevention of Thromboembolic Events in ESRD Patients on Hemodialysis Who Are at Risk for Thromboembolic Events.
• Date of first enrollment: 01/09/2020
• Target sample size: 600
• Countries of recruitment: Japan,Asia except Japan,North America,Europe
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : BAY 1213790
INN of investigational material : osocimab
Therapeutic category code : 333 Anticoagulants
Dosage and Administration for Investigational material : Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses. BAY 1213790 Low dose: Loading dose 105 mg, Maintenace dose 52.5 mg. BAY 1213790 High dose: Loading dose 210 mg, Maintenance dose 105 mg.

control material(s)
Generic name etc : Placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Subcutaneous administration in the same manner as osocimab.

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

- 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

Related Information

• Primary Sponsor: Bayer Yakuhin, Ltd.
• Secondary ID(s): NCT04523220,JapicCTI-205467