NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031200303

Registered date:15/01/2021

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedEnd Stage Renal Disease Requiring Hemodialysis
Date of first enrollment13/01/2021
Target sample size288
Countries of recruitmentBelgium,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 typeInterventional
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 OutcomeIncidence of major bleeding and clinically relevant non-major bleeding during the main treatment period [ Time Frame: Up to 24 weeks ]
Secondary Outcome1.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 maximumNot applicable
GenderBoth
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

Contact

Public contact
Name contact Dedicated
Address 2-4-9 Umeda, Kita-ku, Osaka, Osaka Osaka Japan 530-0001
Telephone +81-6-6133-6363
E-mail byl_ct_contact@bayer.com
Affiliation Bayer Yakuhin, Ltd.
Scientific contact
Name Masashi Myoishi
Address 2-4-9 Umeda, Kita-ku, Osaka, Osaka Osaka Japan 530-0001
Telephone +81-6-6133-6363
E-mail byl_ct_contact@bayer.com
Affiliation Bayer Yakuhin, Ltd.