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

JRCT ID: jRCT2031200303

Registered date:15/01/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: End Stage Renal Disease Requiring Hemodialysis
• Date of first enrollment: 13/01/2021
• Target sample size: 288
• Countries of recruitment: Belgium,Japan,Bulgaria,Japan,Canada,Japan,Czechia,Japan,Germany,Japan,Spain,Japan,Greece,Japan,Hungary,Japan,Latvia,Japan,Russian Federation,Japan,Ukraine,Japan,United states,Japan,Republic of Korea,Japan
• Study type: Interventional
• Intervention(s): Within each dose cohort(40, 80, 120mg), participants will be randomized in a 3:1 ratio to receive SC treatment with either BAY 2976217 or placebo. Study intervention will be administered once every 4 weeks

Outcome(s)

• Primary Outcome: Incidence of major bleeding and clinically relevant non-major bleeding during the main treatment period [ Time Frame: Up to 24 weeks ]

Secondary Outcome

1.Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 24 weeks ]

2.Number of participants with severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 24 weeks ]

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 ]

4.Maximum change in FXI antigen levels during the main treatment period [ Time Frame: Up to 24 weeks ]

5.Maximum change in FXI activity levels during the main treatment period [ Time Frame: Up to 24 weeks ]

Key inclusion & exclusion criteria

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

Include criteria

- 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

Exclude criteria

- 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

Related Information

• Primary Sponsor: Myoishi Masashi
• Secondary ID(s): NCT04534114