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Trial record 1 of 1 for:    NCT04534114
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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 (RE-THINc ESRD)

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ClinicalTrials.gov Identifier: NCT04534114
Recruitment Status : Completed
First Posted : September 1, 2020
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Requiring Hemodialysis Drug: BAY2976217 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 4, 2020
Actual Primary Completion Date : January 24, 2022
Actual Study Completion Date : May 12, 2022

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Pooled Placebo
Participants will be allocated at randomization to 1 of 3 dose cohorts 40 mg, 80 mg and 120 mg and within each cohort to receive subcutaneous treatment with either BAY2976217 or matching placebo.
 Drug: Placebo
Matching placebo to BAY2976217 will be injected subcutaneously.
Experimental: 40 mg BAY2976217
Participants will be allocated at randomization to 1 of 3 dose cohorts 40 mg, 80 mg and 120 mg and within each cohort to receive subcutaneous treatment with either BAY2976217 or matching placebo.
 Drug: BAY2976217
Study intervention will be injected subcutaneously.
Other Name: Factor XI LICA
Experimental: 80 mg BAY2976217
Participants will be allocated at randomization to 1 of 3 dose cohorts 40 mg, 80 mg and 120 mg and within each cohort to receive subcutaneous treatment with either BAY2976217 or matching placebo.
 Drug: BAY2976217
Study intervention will be injected subcutaneously.
Other Name: Factor XI LICA
Experimental: 120 mg BAY2976217
Participants will be allocated at randomization to 1 of 3 dose cohorts 40 mg, 80 mg and 120 mg and within each cohort to receive subcutaneous treatment with either BAY2976217 or matching placebo.
 Drug: BAY2976217
Study intervention will be injected subcutaneously.
Other Name: Factor XI LICA


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of major bleeding and clinically-relevant non-major bleeding during the main treatment period and within the on-treatment time window [ Time Frame: Up to 24 weeks ]
    As assessed by blinded Central Independent Adjudication Committee (CIAC)


Secondary Outcome Measures :
  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 [ Time Frame: Up to 48 weeks ]
    As assessed by blinded Central Independent Adjudication Committee (CIAC)

  2. Number of participants with treatment-emergent adverse events (TEAEs) during the main treatment period and within the on-treatment time window [ Time Frame: Up to 24 weeks ]
  3. Number of participants with TEAEs during the main and extended treatment periods and within the on-treatment time window [ Time Frame: Up to 48 weeks ]
  4. Number of participants with TEAEs during the main and extended treatment periods and until 20 weeks after the last study intervention dose [ Time Frame: Up to 64 weeks ]
  5. Number of participants with TEAEs categorized by severity during the main treatment period and within the on-treatment time window [ Time Frame: Up to 24 weeks ]
  6. Number of participants with TEAEs categorized by severity during the main and extended treatment periods and within the on-treatment time window [ Time Frame: Up to 48 weeks ]
  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 [ Time Frame: Up to 64 weeks ]
  8. Trough concentrations (Ctrough) of three dose levels of BAY2976217 [ Time Frame: At visits V12 (Day 57), V14 (Day 85), V16 (Day 113), V18 (Day 141) ]
  9. Maximum change in FXI antigen levels during the main treatment period [ Time Frame: Up to 24 weeks ]
  10. Maximum change in FXI activity levels during the main treatment period [ Time Frame: Up to 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (<6 months before screening) clinically significant bleeding, or at high risk of bleeding (in the judgement of the investigator)
  • Recent (<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke, or Venous thromboembolism (except dialysis access thrombosis)
  • Recent (<3 months before screening) major surgery or scheduled major surgery during participation in the study
  • Scheduled living donor renal transplant during study participation
  • Known Hepatitis B or C
  • Known HIV with recent documented detectable viral load (<3 months before screening)
  • Persistent heart failure as classified by the New York Heart Association classification of 3 or higher
  • Life expectancy less than 6 months
  • Sustained uncontrolled hypertension (persistent measurements of diastolic blood pressure ≥ 100 mmHg, and/or systolic blood pressure ≥ 180 mmHg)
  • Hepatic disease associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT > 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 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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534114


Locations
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Sponsors and Collaborators
Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04534114    
Other Study ID Numbers: 21170
2019-003927-39 ( EudraCT Number )
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
End stage renal disease (ESRD)
Hemodialysis (HD)
Thrombotic Events
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency