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

Factor XI LICA to Reduce Thrombotic Events in End-Stage Renal Disease Patients on Hemodialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of BAY 2976217 - RE-THINC ESRD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003927-39-GR

Enrollment

340

Registered

2020-07-09

Start date

2020-07-29

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease requiring hemodialysis MedDRA version: 21.0 Level: PT Classification code 10077512 Term: End stage renal disease System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 21.1 Level: LLT Classification code 10019480 Term: Hemodialysis System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: LLT Classification code 10066639 Term: Myocardial infarct prophylaxis System Organ Class: 10042613 - Surgical and medical procedur

Interventions

Product Name: BAY 2976217 100mg/ml Solution for injection Product Code: BAY 2976217 Pharmaceutical Form: Solution for injection INN or Proposed INN: Not available CAS Number: 2380288-85-5 Current Spo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Participant must be at least 18 years of age at the time of signing the ICF. - Participants with ESRD on 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 187 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 153

Exclusion criteria

Exclusion criteria: - Participants receiving antiplatelet therapy except daily ASA = 150 mg/day - Participants receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure - Known inherited bleeding disorder e.g. von-Willebrand disease or Hemophilia A, B or C - Recent ( 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20% of the total - Hb < 9.0 g/dL at screening - Platelet count < 120,000 mm3 at screening - Known hypersensitivity to the investigational drug or to inactive constituents of the study intervention - Active malignancy requiring treatment during study participation (except nonmelanoma skin cancer, or cervical carcinoma in situ) - Participation in a study with an investigational medicinal product within 30 days or within 5 half-lives of the previous administered drug, whichever is longer, prior to the screening/observational period (Note: Participants from previous BAY 2306001/ISIS 416858 and BAY 2976217 / ION 957943 studies are eligible) - Any other conditions, which, in the opinion of the investigator or Sponsor would make the subject unsuitable for inclusion - Confirmed pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety of BAY2976217 compared to placebo;Secondary Objective: To evaluate the PK and PD of BAY2976217;Primary end point(s): Incidence of major bleeding and clinically-relevant non-major bleeding during the main treatment period and within the on-treatment time window, as assessed by blinded Central Independent Adjudication Committee (CIAC);Timepoint(s) of evaluation of this end point: Up to 24 weeks	—

Measure

Time frame

Main Objective: To evaluate the safety of BAY2976217 compared to placebo;Secondary Objective: To evaluate the PK and PD of BAY2976217;Primary end point(s): Incidence of major bleeding and clinically-relevant non-major bleeding during the main treatment period and within the on-treatment time window, as assessed by blinded Central Independent Adjudication Committee (CIAC);Timepoint(s) of evaluation of this end point: Up to 24 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1- Incidence of composite of major bleeding and clinically-relevant non-major bleeding during the main and extended treatment periods and within the on-treatment time window, as assessed by blinded CIAC 2- Number of participants with treatment-emergent adverse events (TEAEs) during the main treatment period and within the on-treatment time window 3- Number of participants with TEAEs during the main and extended treatment periods and within the on-treatment time window 4- Number of participants with TEAEs during the main and extended treatment periods and until 20 weeks after the last study intervention dose 5- Number of participants with TEAEs categorized by severity during the main treatment period and within the on-treatment time window 6- Number of participants with TEAEs categorized by severity during the main and extended treatment periods and within the on-treatment time window 7- Number of participants with TEAEs categorized by severity during the main and extended treatment periods and until 20 weeks after the last study intervention dose 8- Trough concentrations for 3 dose levels of BAY 2976217 9- Maximum change in FXI antigen levels during the main treatment period 10- Maximum change in FXI activity levels during the main treatment period;Timepoint(s) of evaluation of this end point: 1- Up to 48 weeks 2- Up to 24 weeks 3- Up to 48 weeks 4- Up to 64 weeks 5- Up to 24 weeks 6- Up to 48 weeks 7- Up to 64 weeks 8- At visits V12 (Day 57), V14 (Day 85), V16 (Day 113), V18 (Day 141) 9- Up to 24 weeks 10- Up to 24 weeks	—

Measure

Time frame

Secondary end point(s): 1- Incidence of composite of major bleeding and clinically-relevant non-major bleeding during the main and extended treatment periods and within the on-treatment time window, as assessed by blinded CIAC 2- Number of participants with treatment-emergent adverse events (TEAEs) during the main treatment period and within the on-treatment time window 3- Number of participants with TEAEs during the main and extended treatment periods and within the on-treatment time window 4- Number of participants with TEAEs during the main and extended treatment periods and until 20 weeks after the last study intervention dose 5- Number of participants with TEAEs categorized by severity during the main treatment period and within the on-treatment time window 6- Number of participants with TEAEs categorized by severity during the main and extended treatment periods and within the on-treatment time window 7- Number of participants with TEAEs categorized by severity during the main and extended treatment periods and until 20 weeks after the last study intervention dose 8- Trough concentrations for 3 dose levels of BAY 2976217 9- Maximum change in FXI antigen levels during the main treatment period 10- Maximum change in FXI activity levels during the main treatment period;Timepoint(s) of evaluation of this end point: 1- Up to 48 weeks 2- Up to 24 weeks 3- Up to 48 weeks 4- Up to 64 weeks 5- Up to 24 weeks 6- Up to 48 weeks 7- Up to 64 weeks 8- At visits V12 (Day 57), V14 (Day 85), V16 (Day 113), V18 (Day 141) 9- Up to 24 weeks 10- Up to 24 weeks

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Countries

Belgium, Bulgaria, Canada, Czechia, Czech Republic, Germany, Greece, Hungary, Japan, Korea, Republic of, Latvia, Russian Federation, Spain, Taiwan, Ukraine, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com+4930300139003

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026