Factor XI LICA to Reduce Events Such as Heart Attack and Stroke in Patients Whose Kidneys Are no Longer Able to Work as They Should and Require Treatment to Filter Wastes From the Blood: Focus is on the Safety of BAY2976217 and the Way the Body Absorbs, Distributes and Removes the Study Drug
- Conditions
- End Stage Renal Disease Requiring Hemodialysis
- Registration Number
- JPRN-jRCT2031200303
- Lead Sponsor
- Myoishi Masashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 288
Participant must be at least 18 years of age at the time of signing the informed consent form (ICF)
- Participants with ESRD on hemodialysis (HD) for >=3 months at the time of signing of the ICF, receiving dialysis at least 9 hours a week and stable in the view of the investigator
- Male 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)
- Capable of giving signed ICF as described in the Protocol, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
- Participant must be at least 18 years of age at the time of signing the informed consent form (ICF)
- Participants with ESRD on hemodialysis (HD) for >=3 months at the time of signing of the ICF, receiving dialysis at least 9 hours a week and stable in the view of the investigator
- Male 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)
- Capable of giving signed ICF as described in the Protocol, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of major bleeding and clinically relevant non-major bleeding during the main treatment period [ Time Frame: Up to 24 weeks ]
- Secondary Outcome Measures
Name Time Method 1.Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 24 weeks ]<br><br>2.Number of participants with severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 24 weeks ]<br><br>3.Trough concentrations (Ctrough) of three dose levels of BAY2976217 [ Time Frame: At study days 1, 2, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 148, 155, 162 and 169 ]<br><br>4.Maximum change in FXI antigen levels during the main treatment period [ Time Frame: Up to 24 weeks ]<br><br>5.Maximum change in FXI activity levels during the main treatment period [ Time Frame: Up to 24 weeks ]