End Stage Renal Disease Requiring Hemodialysis
Conditions
Interventions
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
Sponsors
Myoishi Masashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major bleeding and clinically relevant non-major bleeding during the main treatment period [ Time Frame: Up to 24 weeks ] | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ] | — |
Countries
Belgium, Bulgaria, Canada, Czechia, Germany, Greece, Hungary, Japan, Latvia, Republic of Korea, Russian Federation, Spain, Ukraine, United states
Contacts
Public Contactcontact Dedicated
Bayer Yakuhin, Ltd.
Outcome results
None listed