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    EudraCT Number:2019-003927-39
    Sponsor's Protocol Code Number:BAY2976217/21170
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-06-09
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2019-003927-39
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberBAY2976217/21170
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04534114
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBayer AG
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBayer AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street Address-
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.4Telephone number+4930300139003
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBAY 2976217 100mg/ml Solution for injection
    D.3.2Product code BAY 2976217
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 2380288-85-5
    D.3.9.2Current sponsor codeBAY 2976217
    D.3.9.3Other descriptive nameION-957943, BAY 2976217 (ION-957943)
    D.3.9.4EV Substance CodeSUB208553
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    End Stage Renal Disease requiring hemodialysis
    E.1.1.1Medical condition in easily understood language
    Kidneys are no longer able to work as they should and require treatment to filter wastes and water from the blood
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10077512
    E.1.2Term End stage renal disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10019480
    E.1.2Term Hemodialysis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066639
    E.1.2Term Myocardial infarct prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10049165
    E.1.2Term Cerebrovascular accident prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the safety of BAY2976217 compared to placebo
    E.2.2Secondary objectives of the trial
    To evaluate the PK and PD of BAY2976217
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Two types of PK/PD sampling will be performed: regular PK/PD sampling in the majority of the participants, and alternative PK/PD sampling in a subset of approximately 24-40 participants.
    E.3Principal 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
    E.4Principal 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 (<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 VTE (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 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
    E.5 End points
    E.5.1Primary 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)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 24 weeks
    E.5.2Secondary end point(s)
    1- Incidence of composite of major bleeding and clinically-relevant nonmajor
    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
    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
    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
    10- Maximum change in FXI activity levels during the main treatment
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Republic of
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 187
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 153
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 340
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard of Care treatment
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-05-12
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