check_circleStudy Completed
End stage renal disease requiring hemodialysis
Bayer Identifier:
21170
ClinicalTrials.gov Identifier:
EudraCT Number:
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
AllAge
18 - N/ATrial summary
Enrollment Goal
307Trial Dates
September 2020 - May 2022Phase
Phase 2Could I Receive a placebo
YesProducts
Fesomersen (BAY2976217)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Robert-Bosch-Krankenhaus | Stuttgart, 70376, Germany |
Withdrawn | Nephrologisches Zentrum Hoyerswerda | Hoyerswerda, 02977, Germany |
Completed | DaVita Clinical Research Deutschland GmbH | Duesseldorf, 40210, Germany |
Completed | Universitätsklinikum Schleswig-Holstein (UKSH) | Kiel, 24105, Germany |
Completed | DaVita Northwest Medical Center Dialysis | San Antonio, 78229, United States |
Withdrawn | DaVita Med Center Dialysis | Houston, 77004-7515, United States |
Withdrawn | DaVita Minneapolis Diaysis Unit | Minneapolis, 55404, United States |
Completed | Fresenius Medical Care - Fire Mesa Dialysis Unit | Las Vegas, 89128, United States |
Completed | San Antonio Kidney Disease Center Physicians Group, PLLC | San Antonio, 78258, United States |
Completed | Chromalloy Dialysis Center | St. Louis, 63110, United States |
Withdrawn | DaVita Orlando North Dialysis | Orlando, 32804, United States |
Completed | Desert Cities Dialysis-Amethyst & Desert Cities Dialysis | Victorville, 92392, United States |
Completed | Fresenius Kidney Care Clovis | Clovis, 93611, United States |
Completed | Fresenius Kidney Care St. Louis Regional Dialysis | St. Ann, 63074, United States |
Completed | Davita East Ft. Lauderdale Dialysis Center | Ft. Lauderdale, 33316, United States |
Withdrawn | Elixia At Clinical Renal Associates | Upland, 19013, United States |
Withdrawn | Fresenius Medical Care Tampa North | Temple Terrace, 33637, United States |
Completed | Hospital Universitario Virgen de las Nieves|Nefrologia | Granada, 18014, Spain |
Completed | Hospital Clínic i Provincial de Barcelona | Barcelona, 8036, Spain |
Completed | Hospital Universitari i Politècnic La Fe | Nefrología | Valencia, 46026, Spain |
Withdrawn | Hospital Sant Joan Despi Moises Broggi | Sant Joan Despi, 08970, Spain |
Withdrawn | Hospital General Universitario Gregorio Marañon | Nefrologia | Madrid, 28007, Spain |
Completed | Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention | Barcelona, 08907, Spain |
Completed | Hospital Principe de Asturias | Alcalá de Henares, 28805, Spain |
Withdrawn | Hospital de Torrecárdenas | Almería, 04009, Spain |
Withdrawn | Complejo Hospitalario de Navarra | Pamplona, 31008, Spain |
Completed | Lakeridge Health-Oshawa | Oshawa, L1G 2B9, Canada |
Withdrawn | Humber River Hospital | Toronto, M3M 0B2, Canada |
Completed | Etobicoke General Hospital | Etobicoke, M9V 1R8, Canada |
Completed | St. Joseph's Healthcare - Hamilton | Hamilton, L8N 4A6, Canada |
Withdrawn | Hopital Charles LeMoyne | Greenfield Park, J4V 2H1, Canada |
Completed | Unity Health Toronto: St. Michael's Hospital | Toronto, M5B 1W8, Canada |
Completed | CHU de Québec-Université Laval | Quebec, G1J 1Z4, Canada |
Completed | Centre de services ambulatoires de dialyse de Gaspé | Montreal, H2T 3B3, Canada |
Completed | Regionaal ZH Jan Yperman Campus Mariaziekenhuis | IEPER, 8900, Belgium |
Completed | UZ Antwerpen | EDEGEM, 2650, Belgium |
Completed | UZ Brussel | BRUXELLES - BRUSSEL, 1090, Belgium |
Completed | OL Vrouwziekenhuis - Campus Aalst | Aalst, 9300, Belgium |
Completed | Oblastni nemocnice Mlada Boleslav | Mlada Boleslav, 293 50, Czechia |
Completed | Nemocnice Frydek-Mistek | Frydek-Mistek, 738 01, Czechia |
Withdrawn | Fakultni nemocnice Brno | Brno, 625 00, Czechia |
Withdrawn | Fresenius Nephro Care s.r.o. | Praha 9 - Vysocany, 190 61, Czechia |
Completed | Klatovska nemocnice | Klatovy, 339 01, Czechia |
Completed | Fresenius Medical Care - DS, s.r.o. | Melnik, 276 01, Czechia |
Withdrawn | “Dialysis center Hemomed” EOOD | Sofia, 1606, Bulgaria |
Completed | MHAT "Knyaginya Klementina - Sofia"EAD | Sofia, 1233, Bulgaria |
Withdrawn | MHAT Sveta Anna | Sofia, 1872, Bulgaria |
Completed | MHAT National Cardiology Hospital EAD | Sofia, 1309, Bulgaria |
Completed | FIRST DIALYSIS SERVICES BULGARIA EAD | Montana, 3400, Bulgaria |
Withdrawn | UMHATEM N. I. Pirogov EAD | Sofia, 1606, Bulgaria |
Completed | MHAT Samokov | Samokov, 2000, Bulgaria |
Withdrawn | Bioclinic Thessaloniki | Thessaloniki, 54622, Greece |
Completed | University General Hospital of Patra | Patra, 26504, Greece |
Completed | PAPANIKOLAOU General Hospital Thessaloniki | Pilea Chortiatis, 57010, Greece |
Completed | University General Hospital of Heraklion | Heraklion, 711 10, Greece |
Withdrawn | Omsk Regional Clinical Hospital | Omsk, 644111, Russian Federation |
Completed | Limited Liability Company "Nefroline-Novosibirsk" | Novosibirsk, 630064, Russian Federation |
Completed | LLC Dialysis center | Podolsk, 142110, Russian Federation |
Completed | High Technology Center Clinic 1 | Moscow, 125466, Russian Federation |
Completed | LLC Frezenius Nefrocare | Penza, 440034, Russian Federation |
Completed | Kyiv City Center of Nephrology and Dialysis | Kyiv, 01023, Ukraine |
Completed | Zaporizhia Municipal Clinical Hospital No.10 | Zaporizhzhya, 69001, Ukraine |
Completed | Regional Clinical Hospital - Odessa | Odesa, 65025, Ukraine |
Completed | Medical Center Fresenius Medical Care Ukraine, LLC | Chernigiv, 14034, Ukraine |
Completed | P. Stradins Clinical University Hospital | Riga, LV-1002, Latvia |
Completed | Vidzemes Hospital | Valmiera, LV-4201, Latvia |
Completed | Liepaja Regional Hospital | Liepaja, LV-3414, Latvia |
Completed | Daugavpils Regional Hospital | Daugavpils, LV-5417, Latvia |
Withdrawn | Med Alfa | Riga, LV-1001, Latvia |
Completed | SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont | Szeged, 6720, Hungary |
Withdrawn | Katai Gabor Korhaz | Karcag, 5300, Hungary |
Completed | Bacs-Kiskun Megyei Korhaz | Kalocsa, 6300, Hungary |
Withdrawn | Mount Sinai Kidney Center | New York, 10035, United States |
Completed | LLC B. Brown Avitum Russland Clinics | St. Petersburg, 196247, Russian Federation |
Completed | Public Central Hospital of Matto Ishikawa | Hakusan, 924-8588, Japan |
Completed | Medical corporation association Shunshin-kai Inage hospital | Chiba, 263-0043, Japan |
Completed | Ibaraki Prefectural Central Hospital | Kasama, 309-1793, Japan |
Completed | Hanyu General Hospital | Hanyu, 348-0045, Japan |
Completed | Sapporo Tokushukai Hospital | Sapporo, 004-0041, Japan |
Completed | Shonan Fujisawa Tokushukai Hospital | Fujisawa, 251-0041, Japan |
Completed | Matsunami General Hospital | Hashima-gun, 501-6062, Japan |
Completed | Salem VA Medical Center | Salem, 24153, United States |
Withdrawn | Hallym University Sacred Heart Hospital | Anyang-si, 14068, Korea, Republic Of |
Completed | The Catholic University of Korea, Incheon St.Mary's Hospital | Incheon, 21431, Korea, Republic Of |
Withdrawn | Kyung Hee University Hospital at Gangdong | Seoul, 05278, Korea, Republic Of |
Withdrawn | Seoul National University Hospital | Seoul, 03080, Korea, Republic Of |
Withdrawn | Korea University Guro Hospital | Seoul, 152-703, Korea, Republic Of |
Completed | Yeouido St. Mary's Hospital | Seoul, 150-713, Korea, Republic Of |
Withdrawn | KyungHee University Hospital | Seoul, 130-872, Korea, Republic Of |
Withdrawn | The Catholic University of Korea Seoul St. Mary's Hospital | Seoul, 137-701, Korea, Republic Of |
Withdrawn | Bundang CHA General Hospital | Gyeonggi-do, 463-712, Korea, Republic Of |
Completed | State Budgetary Healthcare Institution City Hospital #26 | St. Petersburg, 196247, Russian Federation |
Completed | Nikiforov All-Russian Center of Emergency and Radiation Med | Saint-Petersburg, 197374, Russian Federation |
Completed | Botkin clinical infectious diseases hospital | St. Petersburg, 195067, Russian Federation |
Withdrawn | St.Vincent's Hospital | Suwon-si, 442-723, Korea, Republic Of |
Completed | Taipei Medical University Hospital | Taipei, 110, Taiwan |
Withdrawn | Far Eastern Memorial Hospital | New Taipei City, 220, Taiwan |
Completed | Chi Mei Medical Center | Tainan, 710, Taiwan |
Completed | Kyiv Regional Clinical Hospital | Kyiv, 04107, Ukraine |
Completed | Ternopil Regional Clinical Hospital | Ternopil, 46002, Ukraine |
Withdrawn | Chang Gung Memorial Hospital Keelung | Keelung, 20401, Taiwan |
Completed | DaVita Clinical Resarch Germany GmbH | Geilenkirchen, 52511, Germany |
Withdrawn | National Cheng Kung University Hospital | Tainan, 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 CIACMB 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 severityTEAEs 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 severityTEAEs 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 severityTEAEs 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 fesomersenTrough (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 periodThe 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 periodThe 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
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
4