check_circleStudy Completed

End stage renal disease requiring hemodialysis

Bayer Identifier:

21170

ClinicalTrials.gov Identifier:

NCT04534114

EudraCT Number:

2019-003927-39

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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
  • - 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 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

Trial summary

Enrollment Goal
307
Trial Dates
September 2020 - May 2022
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Fesomersen (BAY2976217)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Robert-Bosch-KrankenhausStuttgart, 70376, Germany
Withdrawn
Nephrologisches Zentrum HoyerswerdaHoyerswerda, 02977, Germany
Completed
DaVita Clinical Research Deutschland GmbHDuesseldorf, 40210, Germany
Completed
Universitätsklinikum Schleswig-Holstein (UKSH)Kiel, 24105, Germany
Completed
DaVita Northwest Medical Center DialysisSan Antonio, 78229, United States
Withdrawn
DaVita Med Center DialysisHouston, 77004-7515, United States
Withdrawn
DaVita Minneapolis Diaysis UnitMinneapolis, 55404, United States
Completed
Fresenius Medical Care - Fire Mesa Dialysis UnitLas Vegas, 89128, United States
Completed
San Antonio Kidney Disease Center Physicians Group, PLLCSan Antonio, 78258, United States
Completed
Chromalloy Dialysis CenterSt. Louis, 63110, United States
Withdrawn
DaVita Orlando North DialysisOrlando, 32804, United States
Completed
Desert Cities Dialysis-Amethyst & Desert Cities DialysisVictorville, 92392, United States
Completed
Fresenius Kidney Care ClovisClovis, 93611, United States
Completed
Fresenius Kidney Care St. Louis Regional DialysisSt. Ann, 63074, United States
Completed
Davita East Ft. Lauderdale Dialysis CenterFt. Lauderdale, 33316, United States
Withdrawn
Elixia At Clinical Renal AssociatesUpland, 19013, United States
Withdrawn
Fresenius Medical Care Tampa NorthTemple Terrace, 33637, United States
Completed
Hospital Universitario Virgen de las Nieves|NefrologiaGranada, 18014, Spain
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 8036, Spain
Completed
Hospital Universitari i Politècnic La Fe | NefrologíaValencia, 46026, Spain
Withdrawn
Hospital Sant Joan Despi Moises BroggiSant Joan Despi, 08970, Spain
Withdrawn
Hospital General Universitario Gregorio Marañon | NefrologiaMadrid, 28007, Spain
Completed
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke PreventionBarcelona, 08907, Spain
Completed
Hospital Principe de AsturiasAlcalá de Henares, 28805, Spain
Withdrawn
Hospital de TorrecárdenasAlmería, 04009, Spain
Withdrawn
Complejo Hospitalario de NavarraPamplona, 31008, Spain
Completed
Lakeridge Health-OshawaOshawa, L1G 2B9, Canada
Withdrawn
Humber River HospitalToronto, M3M 0B2, Canada
Completed
Etobicoke General HospitalEtobicoke, M9V 1R8, Canada
Completed
St. Joseph's Healthcare - HamiltonHamilton, L8N 4A6, Canada
Withdrawn
Hopital Charles LeMoyneGreenfield Park, J4V 2H1, Canada
Completed
Unity Health Toronto: St. Michael's HospitalToronto, M5B 1W8, Canada
Completed
CHU de Québec-Université LavalQuebec, G1J 1Z4, Canada
Completed
Centre de services ambulatoires de dialyse de GaspéMontreal, H2T 3B3, Canada
Completed
Regionaal ZH Jan Yperman Campus MariaziekenhuisIEPER, 8900, Belgium
Completed
UZ AntwerpenEDEGEM, 2650, Belgium
Completed
UZ BrusselBRUXELLES - BRUSSEL, 1090, Belgium
Completed
OL Vrouwziekenhuis - Campus AalstAalst, 9300, Belgium
Completed
Oblastni nemocnice Mlada BoleslavMlada Boleslav, 293 50, Czechia
Completed
Nemocnice Frydek-MistekFrydek-Mistek, 738 01, Czechia
Withdrawn
Fakultni nemocnice BrnoBrno, 625 00, Czechia
Withdrawn
Fresenius Nephro Care s.r.o.Praha 9 - Vysocany, 190 61, Czechia
Completed
Klatovska nemocniceKlatovy, 339 01, Czechia
Completed
Fresenius Medical Care - DS, s.r.o.Melnik, 276 01, Czechia
Withdrawn
“Dialysis center Hemomed” EOODSofia, 1606, Bulgaria
Completed
MHAT "Knyaginya Klementina - Sofia"EADSofia, 1233, Bulgaria
Withdrawn
MHAT Sveta AnnaSofia, 1872, Bulgaria
Completed
MHAT National Cardiology Hospital EADSofia, 1309, Bulgaria
Completed
FIRST DIALYSIS SERVICES BULGARIA EADMontana, 3400, Bulgaria
Withdrawn
UMHATEM N. I. Pirogov EADSofia, 1606, Bulgaria
Completed
MHAT SamokovSamokov, 2000, Bulgaria
Withdrawn
Bioclinic ThessalonikiThessaloniki, 54622, Greece
Completed
University General Hospital of PatraPatra, 26504, Greece
Completed
PAPANIKOLAOU General Hospital ThessalonikiPilea Chortiatis, 57010, Greece
Completed
University General Hospital of HeraklionHeraklion, 711 10, Greece
Withdrawn
Omsk Regional Clinical HospitalOmsk, 644111, Russian Federation
Completed
Limited Liability Company "Nefroline-Novosibirsk"Novosibirsk, 630064, Russian Federation
Completed
LLC Dialysis centerPodolsk, 142110, Russian Federation
Completed
High Technology Center Clinic 1Moscow, 125466, Russian Federation
Completed
LLC Frezenius NefrocarePenza, 440034, Russian Federation
Completed
Kyiv City Center of Nephrology and DialysisKyiv, 01023, Ukraine
Completed
Zaporizhia Municipal Clinical Hospital No.10Zaporizhzhya, 69001, Ukraine
Completed
Regional Clinical Hospital - OdessaOdesa, 65025, Ukraine
Completed
Medical Center Fresenius Medical Care Ukraine, LLCChernigiv, 14034, Ukraine
Completed
P. Stradins Clinical University HospitalRiga, LV-1002, Latvia
Completed
Vidzemes HospitalValmiera, LV-4201, Latvia
Completed
Liepaja Regional HospitalLiepaja, LV-3414, Latvia
Completed
Daugavpils Regional HospitalDaugavpils, LV-5417, Latvia
Withdrawn
Med AlfaRiga, LV-1001, Latvia
Completed
SZTE ÁOK Szent Györgyi Albert Klinikai KozpontSzeged, 6720, Hungary
Withdrawn
Katai Gabor KorhazKarcag, 5300, Hungary
Completed
Bacs-Kiskun Megyei KorhazKalocsa, 6300, Hungary
Withdrawn
Mount Sinai Kidney CenterNew York, 10035, United States
Completed
LLC B. Brown Avitum Russland ClinicsSt. Petersburg, 196247, Russian Federation
Completed
Public Central Hospital of Matto IshikawaHakusan, 924-8588, Japan
Completed
Medical corporation association Shunshin-kai Inage hospitalChiba, 263-0043, Japan
Completed
Ibaraki Prefectural Central HospitalKasama, 309-1793, Japan
Completed
Hanyu General HospitalHanyu, 348-0045, Japan
Completed
Sapporo Tokushukai HospitalSapporo, 004-0041, Japan
Completed
Shonan Fujisawa Tokushukai HospitalFujisawa, 251-0041, Japan
Completed
Matsunami General HospitalHashima-gun, 501-6062, Japan
Completed
Salem VA Medical CenterSalem, 24153, United States
Withdrawn
Hallym University Sacred Heart HospitalAnyang-si, 14068, Korea, Republic Of
Completed
The Catholic University of Korea, Incheon St.Mary's HospitalIncheon, 21431, Korea, Republic Of
Withdrawn
Kyung Hee University Hospital at GangdongSeoul, 05278, Korea, Republic Of
Withdrawn
Seoul National University HospitalSeoul, 03080, Korea, Republic Of
Withdrawn
Korea University Guro HospitalSeoul, 152-703, Korea, Republic Of
Completed
Yeouido St. Mary's HospitalSeoul, 150-713, Korea, Republic Of
Withdrawn
KyungHee University HospitalSeoul, 130-872, Korea, Republic Of
Withdrawn
The Catholic University of Korea Seoul St. Mary's HospitalSeoul, 137-701, Korea, Republic Of
Withdrawn
Bundang CHA General HospitalGyeonggi-do, 463-712, Korea, Republic Of
Completed
State Budgetary Healthcare Institution City Hospital #26St. Petersburg, 196247, Russian Federation
Completed
Nikiforov All-Russian Center of Emergency and Radiation MedSaint-Petersburg, 197374, Russian Federation
Completed
Botkin clinical infectious diseases hospitalSt. Petersburg, 195067, Russian Federation
Withdrawn
St.Vincent's HospitalSuwon-si, 442-723, Korea, Republic Of
Completed
Taipei Medical University HospitalTaipei, 110, Taiwan
Withdrawn
Far Eastern Memorial HospitalNew Taipei City, 220, Taiwan
Completed
Chi Mei Medical CenterTainan, 710, Taiwan
Completed
Kyiv Regional Clinical HospitalKyiv, 04107, Ukraine
Completed
Ternopil Regional Clinical HospitalTernopil, 46002, Ukraine
Withdrawn
Chang Gung Memorial Hospital KeelungKeelung, 20401, Taiwan
Completed
DaVita Clinical Resarch Germany GmbHGeilenkirchen, 52511, Germany
Withdrawn
National Cheng Kung University HospitalTainan, 704, Taiwan

Primary Outcome

  • 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)
    MB is defined as symptomatic bleeding and: 1) Fatal bleeding, and/or; 2) Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3) Bleeding causing a fall in hemoglobin level of 20 g/L (2.0 g/dL) (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. CRNMB is defined as any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: 1) Requiring medical intervention by a healthcare professional; 2) Leading to hospitalization or increased level of care; 3) Prompting a face-to-face evaluation. n/100 person-years: number of subjects with incident events divided by the cumulative at-risk time in the reference population, where a subject is no longer at risk once an incident event occurred.
    date_rangeTime Frame:
    Up to 24 weeks

Secondary Outcome

  • 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
    MB is defined as symptomatic bleeding and: 1) Fatal bleeding, and/or; 2) Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3) Bleeding causing a fall in hemoglobin level of 20 g/L (2.0 g/dL) (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. CRNMB is defined as any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: 1) Requiring medical intervention by a healthcare professional; 2) Leading to hospitalization or increased level of care; 3) Prompting a face-to-face evaluation. n/100 person-years: number of subjects with incident events divided by the cumulative at-risk time in the reference population, where a subject is no longer at risk once an incident event occurred.
    date_rangeTime Frame:
    Up to 48 weeks
  • Number of participants with treatment-emergent adverse events (TEAEs) during the main treatment period and within the on-treatment time window and their severity
    TEAEs were analyzed during the on-treatment time window within the main treatment period in the safety analysis set (SAF). Data observed from the randomization date until the end of the main treatment period. TEAEs were defined as events occurring after first study intervention administration and up to 20 weeks after last study intervention administration.
    date_rangeTime Frame:
    Up to 24 weeks
  • Number of participants with TEAEs during the main and extended treatment periods and within the on-treatment time window and their severity
    TEAEs were analyzed during during main and extended treatment periods in the safety analysis set (SAF). Data observed from the randomization date until the end of the extension treatment period. TEAEs were defined as events occurring after first study intervention administration and up to 20 weeks after last study intervention administration.
    date_rangeTime Frame:
    Up to 48 weeks
  • 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
    TEAEs occurring from first study intervention intake until 20 weeks after last study intervention intake.
    date_rangeTime Frame:
    Up to 48 weeks
  • Trough concentrations (Ctrough) of three dose levels of fesomersen
    Trough (pre-dose) fesomersen-equivalent plasma concentrations (Ctrough) for 3 dose levels of fesomersen were summarized descriptively by dose level and visit: Visit 12, Visit 14, Visit 16, Visit 18 (main treatment period). Ctrough was not measured for the placebo group.
    date_rangeTime Frame:
    At visits V12 (Day 57), V14 (Day 85), V16 (Day 113), V18 (Day 141)
  • Maximum change in FXI (coagulation factor XI) antigen levels during the main treatment period
    The secondary endpoint of change in FXI antigen levels during the main treatment period was an optional secondary endpoint only as mentioned in the integrated clinical protocol amendment version 3.0 and was not analyzed in this study as the FXI activity assay is sufficient to describe the effect on FXI level in plasma.
    date_rangeTime Frame:
    Up to 24 weeks
  • Maximum change in FXI activity levels during the main treatment period
    The FXIa activity was measured by a fluorogenic activated FXIa activity (AXIA) assay. Absolute change from baseline at each visit until Visit 22 (Day 169) are reported.
    date_rangeTime Frame:
    Baseline, Days 1 (Pre-Dose and 5 hours post-dose), 2, 8, 15, 22, 29 (Pre-dose and 5 hours post-dose), 43, 57 (Pre-dose), 71, 85 (Pre-dose), 113 (Pre-dose), 141 (Pre-dose),148, 155, 162, and 169 (Pre-dose)

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
4

Additional Information

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