Phase 2
Completed N=307
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
End Stage Renal Disease Requiring Hemodialysis
Source: ClinicalTrials.gov NCT04534114 ↗
Enrolled (actual)
307
Serious AEs
24.1%
Results posted
Jul 2023
Primary outcomePrimary: Incidence of Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) During the Main Treatment Period and Within the On-treatment Time Window, as Assessed by Blinded Central Independent Adjudication Committee (CIAC) — 9.0; 9.1; 6.1; 9.7 n/100 person-years — p=0.944
Summary
Patients whose kidneys are no longer able to work as they should and require treatment to filter wastes from the blood (hemodialysis) are at high risk for blood clots that form in blood vessels (thrombosis) blocking blood flow that causes heart attacks, strokes, and other life-threatening conditions. BAY2976217 is under clinical development for prevention of thrombosis. The goal of the study is to learn more about the safety of BAY2976217, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as multiple doses in participants with renal impairment who require hemodialysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) During the Main Treatment Period and Within the On-treatment Time Window, as Assessed by Blinded Central Independent Adjudication Committee (CIAC) |
9.0; 9.1; 6.1; 9.7 | 0.944 |
| SECONDARY Incidence of Composite of MB and CRNMB During the Main and Extended Treatment Periods and Within the On-treatment Time Window, as Assessed by Blinded CIAC |
10.7; 8.6; 6.4; 7.0 | 0.612 |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Main Treatment Period and Within the On-treatment Time Window and Their Severity |
54; 56; 55; 55; 28; 28 | — |
| SECONDARY Number of Participants With TEAEs During the Main and Extended Treatment Periods and Within the On-treatment Time Window and Their Severity |
61; 62; 58; 56; 26; 25 | — |
| SECONDARY Number of Participants With TEAEs During the Main and Extended Treatment Periods and Until 20 Weeks After the Last Study Intervention Dose and Their Severity |
64; 63; 62; 59; 21; 21 | — |
| SECONDARY Trough Concentrations (Ctrough) of Three Dose Levels of Fesomersen |
0.000454; 0.000704; 0.001186; 0.000490; 0.000792; 0.001246 | — |
| SECONDARY Maximum Change in FXI (Coagulation Factor XI) Antigen Levels During the Main Treatment Period |
— | — |
| SECONDARY Maximum Change in FXI Activity Levels During the Main Treatment Period |
0.00; 0.00; 0.00; 0.00; 0.06; 0.05 | — |
Eligibility 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
- Participants receiving antiplatelet therapy except daily acetylsalicylic acid (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 mm^3 at screening
- Known hypersensitivity to the investigational drug or to inactive constituents of the study intervention
- Active malignancy requiring treatment during study participation (except non-melanoma 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 BAY2306001/ISIS 416858 and BAY2976217/ 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
Data sourced from ClinicalTrials.gov (NCT04534114). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.