check_circleStudy Completed
End-stage renal disease, Prevention of thromboembolic events, Hemodialysis, Hemodiafiltration
Bayer Identifier:
20115
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to investigate the safety of a drug called osocimab at low and high doses in adult patients with kidney failure requiring regular hemodialysis
Trial purpose
In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug.
Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
704Trial Dates
August 2020 - May 2022Phase
Phase 2Could I Receive a placebo
YesProducts
Osocimab (BAY1213790)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Completed | Epicura | Baudour, 7331, Belgium |
Completed | Hospital Clínico Universitario de Valencia | Valencia, 46010, Spain |
Completed | Hospital Clínico Universitario de Santiago de Compostela | Santiago de Compostela, 15706, Spain |
Completed | Hospital Universitario Dr. Peset | Valencia, 46017, Spain |
Completed | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Roma, 00168, Italy |
Completed | A.O.U. Careggi | Firenze, 50134, Italy |
Completed | IRCCS Istituti Clinici Scientifici Maugeri SpA SB | Pavia, 27100, Italy |
Completed | A.O.U. di Bologna Policlinico S.Orsola Malpighi | Bologna, 40138, Italy |
Completed | Health Corporation of Galilee Medical Center | Nahariya, 2210001, Israel |
Completed | Poriya Medical Center | Nephrology and Hypertension Dept. | Tiberius, 1528001, Israel |
Completed | Barzilai Medical Center | Nephrology & Hypertension Dept. | Ashkelon, 7830604, Israel |
Completed | Corporació Sanitària Parc Taulí | Sabadell, 08208, Spain |
Completed | Hospital Althaia, Xarxa Assistencial de Manresa | Manresa, 08243, Spain |
Completed | Hospital Clinico Universitario San Carlos | Nefrologia | Madrid, 28040, Spain |
Completed | General Hospital of Athens LAIKO | Athens, 11527, Greece |
Completed | General Hospital of Thessaloniki Papageorgiou | Thessaloniki, 56403, Greece |
Completed | Hippokration General Hospital of Thessaloniki | Thessaloniki, 54642, Greece |
Completed | University General Hospital of Larissa | Larissa, 41110, Greece |
Completed | HIPPOKRATION General Hospital of Athens | Athens, 115 27, Greece |
Completed | Ioannina University General Hospital | Ioannina, 45500, Greece |
Withdrawn | Hôpital Pasteur - Nice | NICE, 06200, France |
Withdrawn | Centre Hospitalier - Arras | Arras, 62000, France |
Completed | Krajska Nemocnice Liberec | Liberec, 460 63, Czechia |
Completed | Privamed s.r.o. | Plzen, 323 33, Czechia |
Completed | Fresenius Nephro Care s.r.o. - Sokolov | Sokolov, 356 01, Czechia |
Completed | Klinik Landstraße - Krankenhaus Rudolfstiftung | Wien, 1030, Austria |
Withdrawn | Medizinische Universität Graz | Graz, 8036, Austria |
Completed | Klinikum Klagenfurt am Wörthersee | Klagenfurt, 9020, Austria |
Completed | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Completed | Privatklinik Wehrle-Diakonissen | Salzburg, 5026, Austria |
Completed | Brovarskaya multidisciplinary clinical hospital | Brovary, 07400, Ukraine |
Completed | Kyiv City Center of Nephrology and Dialysis | Kyiv, 02660, Ukraine |
Completed | Medical center LLC " Fresenius medical care Ukraine» | Cherkasy, 18009, Ukraine |
Completed | Regional Clinical Hospital - Ivano-Frankivsk | Ivano-Frankivsk, 76000, Ukraine |
Withdrawn | Private enterprise private production company " Acinus" | Kropyvnytskyi, 25006, Ukraine |
Completed | State Institution “Institute of Nephrology” NAMS of Ukraine | Kyiv, 04050, Ukraine |
Completed | Mykolaiv Regional Clinical Hospital | Mykolaiv, 54058, Ukraine |
Completed | Vinnitsa Regional Clinical Hospital im. N.I. Pirogov | Vinnytsia, 21018, Ukraine |
Completed | Zaporizhzhia Regional Clinical Hospital | Zaporizhzhya, 69600, Ukraine |
Completed | Transcarpatian Regional Clinical Hospital | Uzhgorod, 88018, Ukraine |
Completed | Eurodial Obidos (DaVita) | Gaeiras - Obidos, 2510-702, Portugal |
Completed | CHLO - Hospital Santa Cruz | Carnaxide, 2795-53, Portugal |
Completed | Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department | Torres Novas, 2350-754, Portugal |
Completed | Diaverum Aveiro | Aveiro, 3800-266, Portugal |
Completed | Eurodial Leiria (DaVita) | Leiria, 2400-441, Portugal |
Completed | Van Buren Dialysis Center | Riverside, 92503, United States |
Completed | A.O.U. di Parma | Parma, 43126, Italy |
Completed | IRCCS Ospedale Policlinico San Martino | Genova, 16132, Italy |
Completed | AUSL-IRCCS di Reggio Emilia | Reggio Emilia, 42123, Italy |
Withdrawn | ASST Lodi | Lodi, 26900, Italy |
Completed | Caledial - Centro de Hemodialise de Gaia | Canelas, 4410-313, Portugal |
Completed | DaVita South Valley Dialysis | Encino, 91316, United States |
Completed | North America Research Institute - Azusa | Azusa, 91702, United States |
Withdrawn | Groupe Hospitalier Sud - Amiens | Amiens cedex 1, 80054, France |
Withdrawn | Centre Hospitalier Universitaire-Hotel Dieu | Nantes, 44093, France |
Withdrawn | Hôpital Tenon | PARIS, 75020, France |
Withdrawn | Hopital Lapeyronie | Montpellier Cedex 5, 34295, France |
Withdrawn | Hôpital de la Maison Blanche - Reims | REIMS, 51092, France |
Withdrawn | City Clinical Hospital of Emergency Care #1 | Omsk, 644112, Russian Federation |
Completed | Sverdlovsk Regional Clinical Hospital #1 | Yekaterinburg, 620102, Russian Federation |
Withdrawn | Regional Clinical Hospital Krasnoyarsk | Krasnoyarsk, 660022, Russian Federation |
Completed | City Hospital #31 | St. Petersburg, 197110, Russian Federation |
Completed | LLC Fresenius medical care Kuban | Krasnodar, 350029, Russian Federation |
Completed | LLC B. Brown Avitum Russland Clinics | St. Petersburg, 193318, Russian Federation |
Completed | LLC Dialysis center | Mytishchi, 141007, Russian Federation |
Completed | LLC Dialysis center | Kolomna, 140402, Russian Federation |
Completed | LLC Yaroslavl dialysis center | Yaroslavl, 150062, Russian Federation |
Withdrawn | LLC Dialysis center Saint-Petersburg | Saint-Petersburg, 194354, Russian Federation |
Withdrawn | Nikolaevskaya Hospital | St. Petersburg, 198510, Russian Federation |
Withdrawn | City Hospital #52 | Moscow, 123182, Russian Federation |
Completed | Republican Hospital n.a. V.A. Baranov | Petrozavodsk, 185019, Russian Federation |
Completed | Fresenius Kidney Care Evergreen Park | Evergreen Park, 60805, United States |
Completed | Hospital Universitari Germans Trias i Pujol | Badalona, 08916, Spain |
Completed | Clalit Health Services Rabin Medical Center-Beilinson Campus | Petah Tikva, 4941492, Israel |
Completed | Shamir Medical Center (Assaf Harofeh) | Zerifin, 7030000, Israel |
Completed | Lady Davis Carmel Medical Center | Haifa, 3436212, Israel |
Completed | Kharkiv regional Clinical Centre of urology and nephrology | Kharkiv, 61037, Ukraine |
Completed | Academisch Medisch Centrum (AMC) | AMSTERDAM, 1105 AZ, Netherlands |
Completed | Albert Schweitzer Ziekenhuis, Dordwijk | DORDRECHT, 3318 AT, Netherlands |
Withdrawn | Klaipeda Republican Hospital | Klaipeda, LT-92231, Lithuania |
Completed | DaVita Butler Farm Dialysis | Hampton, 23666, United States |
Completed | ARA Holyoke Dialysis Center | Holyoke, 01040, United States |
Completed | East L.A. Dialysis Center | Los Angeles, 90022, United States |
Completed | Deventer Ziekenhuis | DEVENTER, 7416 SE, Netherlands |
Withdrawn | Vilnius University Hospital Santaros Klinikos | Vilnius, LT-08661, Lithuania |
Completed | Imeldaziekenhuis - St-Elisabethkliniek | Bonheiden, 2820, Belgium |
Completed | AZ Nikolaas Campus Sint-Niklaas | SINT-NIKLAAS, 9100, Belgium |
Completed | CHU de Liege | CHR Citadel - Department of Nephrology | LIEGE, 4000, Belgium |
Completed | LUHS Kauno Hospital (Josvainiu str.) | Kaunas, LT-47116, Lithuania |
Completed | Liberty Dialysis- Caldwell | Caldwell, 83605, United States |
Withdrawn | DaVita College Park Dialysis | Woodlands, 77384, United States |
Withdrawn | Westover Dialysis | San Antonio, 78251, United States |
Completed | Queen’s Dialysis Unit | West Covina, 91790, United States |
Completed | NephroCare APDP | Lisboa, 1250-191, Portugal |
Completed | Pluribus Dialise - Cascais (DaVita) | Cascais, 2750-663, Portugal |
Withdrawn | Peking University First Hospital | Beijing, 100034, China |
Completed | Davita Hospital Hill Dialysis | Kansas City, 64108, United States |
Completed | Fresenius Kidney Care South Dialysis | Shreveport, 71106, United States |
Completed | Waterloo Dialysis | Austin, 78756, United States |
Completed | Durham Nephrology Associates, Pa | Durham, 27704, United States |
Completed | Stacja Dializ W-wa Mangalia | Warszawa, 02-758, Poland |
Completed | NZOZ Nowy Szpital w Swieciu Sp. z o.o. | Swiecie, 86-100, Poland |
Completed | Stacja Dializ Olkusz | Olkusz, 32-300, Poland |
Withdrawn | Stacja Dializ Brzeg | Brzeg, 49-301, Poland |
Completed | Stacja Dializ Zyrardow | Zyrardow, 96-300, Poland |
Completed | Maasstad Ziekenhuis | Neurology Department | Rotterdam, 3079DZ, Netherlands |
Withdrawn | MHAT Dr. Bratan Shukerov AD | Smolyan, 4700, Bulgaria |
Withdrawn | MHAT Dobrich | Dobrich, 9300, Bulgaria |
Withdrawn | Acibadem City Clinic Multiprofile Hospital for Active Treatm | Sofia, 1407, Bulgaria |
Completed | UMHAT Kanev AD | Ruse, 7002, Bulgaria |
Withdrawn | Multiprofile Hospital for Active Treatment Sv. Anna | Varna, 9000, Bulgaria |
Completed | MHAT Sveti Ivan Rilski 2003 | Dupnitsa, 2600, Bulgaria |
Completed | MHAT Haskovo | Haskovo, 6300, Bulgaria |
Completed | Multiprofile Hospital for Active Treatment Hristo Botev AD | Vratsa, 3000, Bulgaria |
Completed | Keszthelyi Korhaz | Keszthely, 8360, Hungary |
Completed | Bajai Szent Rokus Korhaz | Baja, 6500, Hungary |
Completed | Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely | Hodmezovasarhely, 6800, Hungary |
Completed | Fresenius Medical Care Egeszsegugyi Kft. | Pecs, 7624, Hungary |
Completed | Fresenius Medical Care Egeszsegugyi Kft. | Budapest, 1083, Hungary |
Withdrawn | Huashan Hospital, Fudan University | Shanghai, 200040, China |
Withdrawn | West China Hospital Sichuan University | Chengdu, 610041, China |
Completed | Saiyu Clinic | Koshigaya, 343-0823, Japan |
Completed | Kikuchi Medical Clinic | Tsukuba, 305-0861, Japan |
Completed | Akagaki Clinic | Osaka, 543-0052, Japan |
Completed | Saint Hill Hospital | Ube, 755-0155, Japan |
Completed | Katta General Hospital | Shiraishi, 989-0231, Japan |
Completed | Ohishi Naika Clinic | Tsuchiura, 300-0835, Japan |
Completed | Kyoto Station Takeda Dialysis Clinic | Kyoto, 600-8216, Japan |
Withdrawn | Chibana Clinic | Okinawa, 904-2143, Japan |
Completed | Nagaoka Red Cross Hospital | Nagaoka, 940-2085, Japan |
Completed | Ibaraki Seinan Medical Center Hospital | Sashima-gun, 306-0433, Japan |
Completed | FMC San Ysidro | San Diego, 92154, United States |
Completed | Liberty Dialysis St. George | St. George, 84790, United States |
Completed | Fresenius Kidney Care Baton Rouge Mancuso Lane | Baton Rouge, 70808, United States |
Completed | Fresenius Kidney Care - La Mesa | La Mesa, 91942, United States |
Completed | ARA Plantation Dialysis, LLC | Ellenton, 34222, United States |
Withdrawn | Midwest Nephrology Group, PLLC | Midwest City, 73130, United States |
Completed | Fresenius Kidney Care Sugar Land | Sugar Land, 77479, United States |
Completed | ARA Augusta | Augusta, 30901, United States |
Completed | Renal Medicine Associates | Albuquerque, 87109, United States |
Completed | DaVita Greater Waterbury Dialysis | Waterbury, 06708, United States |
Completed | Fresenius Kidney Care Kearny Mesa | San Diego, 92111, United States |
Withdrawn | FMC-Allentown | Allentown, 18103, United States |
Completed | Fresenius North Austin Dialysis Center | Austin, 78758, United States |
Withdrawn | Fresenius Medical Care - Central San Antonio | San Antonio, 78207, United States |
Completed | Fresenius Kidney Care – Mission Bend (FMCNA #3971) | Houston, 77083, United States |
Completed | Yabuki Hospital | Yamagata, 990-0885, Japan |
Completed | Akebono Clinic | Kumamoto, 861-4112, Japan |
Completed | Fresenius Medical Care Egeszsegugyi Kft. | Miskolc, 3526, Hungary |
Completed | AZ St-Lucas Campus St-Lucas | gent, 9000, Belgium |
Withdrawn | Centre Hospitalier de Wallonie picarde | Tournai, 7500, Belgium |
Completed | Catharina Ziekenhuis | EINDHOVEN, 5623 EJ, Netherlands |
Completed | Takemura Medical Nephro Clinic | Kanuma, 322-0029, Japan |
Completed | Futakotamagawaekimae clinic | Setagaya-ku, 158-0094, Japan |
Completed | Tsuchiura Beryl Clinic | Tsuchiura, 300-0062, Japan |
Withdrawn | Hopital de la Conception - Marseille | MARSEILLE, 13005, France |
Withdrawn | Hôpital Civil - Strasbourg | STRASBOURG, 67091, France |
Completed | Fakultni nemocnice Ostrava | Ostrava, 708 52, Czechia |
Completed | Lutsk city clinical hospital | Lutsk, 43024, Ukraine |
Withdrawn | Regional Clinical Hospital-Lviv | Lviv, 79000, Ukraine |
Withdrawn | Ukrainska Medychna Stomatologichna Akademiia | Poltava, 314039, Ukraine |
Completed | Kocaeli Universitesi Tip Fakultesi | Kocaeli, 41380, Turkey |
Completed | Hacettepe Universitesi Tip Fakultesi | Ankara, 06230, Turkey |
Completed | Turk Bobrek Vakfi Memorial Hizmet Hastanesi | Istanbul, 34180, Turkey |
Completed | Erciyes Universitesi Tip Fakultesi | Kayseri, 38039, Turkey |
Completed | Inonu Universitesi Tip Fakultesi | Malatya, 44280, Turkey |
Completed | Adnan Menderes Universitesi Tip fakultesi | Aydin, 09100, Turkey |
Completed | Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi | Istanbul, 34418, Turkey |
Withdrawn | Bukovinian State Medical Academy Regional | Chernivtsi, 58000, Ukraine |
Withdrawn | SP Szpital Klilniczny im. Mieleckiego | Katowice, 40-027, Poland |
Completed | Wojewodzki Szpital Zespolony | Kielce, 25-736, Poland |
Withdrawn | Centrum Dializ Fresenius Tarnowskie Gory | Tarnowskie Gory, 42-612, Poland |
Completed | Fresenius Kidney Care - Brawley | Brawley, 92227, United States |
Completed | Kupchinsky center for outpatient dialysis | St. Petersburg, 192102, Russian Federation |
Completed | Chelyabinsk Regional Clinical Hospital | Chelyabinsk, 454076, Russian Federation |
Completed | City Clinical Hospital #1 Orenburg | Orenburg, 460040, Russian Federation |
Completed | Dnepropetrovsk regional hospital n.a. I. I. Mechnikov | Dnipro, 49005, Ukraine |
Completed | Pluribus Dialise - Sacavem (DaVita) | Sacavem, 2685-005, Portugal |
Completed | John Hunter Hospital | New Lambton Heights, 2305, Australia |
Withdrawn | Monash Medical Centre | Clayton, 3168, Australia |
Withdrawn | Gold Coast University Hospital | Southport, 4215, Australia |
Completed | Eastern Health Integrated Renal Service | Box Hill, 3128, Australia |
Completed | Sydney Adventist Hospital | Wahroonga, 2076, Australia |
Withdrawn | Zhongda Hospital Southeast University | Nanjing, 210009, China |
Withdrawn | Peking University Shenzhen Hospital | Shenzhen, 518036, China |
Withdrawn | SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHos | Chengdu, 610072, China |
Completed | Eszak-Pesti Centrumkorhaz-Honvedkorhaz | Budapest, 1134, Hungary |
Completed | General Hospital of Arta | Arta, 47100, Greece |
Withdrawn | S.C. Avitum SRL - Centrul dializa Avitum Resita | Resita, 320167, Romania |
Withdrawn | Diaverum Romania SRL Bucuresti | Bucharest, 060044, Romania |
Withdrawn | Diaverum Romania SRL Craiova | Craiova, 200349, Romania |
Completed | SPD - Amadora (Diaverum Amadora) | Amadora, 2700-001, Portugal |
Completed | Westmead Hospital | Westmead, 2145, Australia |
Completed | MHAT Shumen AD | Shumen, 9700, Bulgaria |
Completed | Gelre Ziekenhuizen | APELDOORN, 7334 DZ, Netherlands |
Withdrawn | St. Martyr Elizaveta Hospital | St. Petersburg, 195257, Russian Federation |
Withdrawn | S.C. Avitum SRL | Târgu Jiu, 210146, Romania |
Withdrawn | Diaverum Romania SRL | Bucharest, 032895, Romania |
Withdrawn | Diaverum Romania SRL Oradea | Oradea, 410562, Romania |
Withdrawn | Institute of Diabetology N. Paulescu | Bucuresti, 020475, Romania |
Withdrawn | Fundeni Clinical Institute | Bucuresti, 022328, Romania |
Completed | Rabin Medical Center, HaSharon (Golda) Campus | Petach Tikva, 4937211, Israel |
Completed | Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi | Poltava, 36011, Ukraine |
Withdrawn | Stacja Dializ Legnica | Legnica, 59-220, Poland |
Withdrawn | Stacja Dializ Tomaszow Mazowiecki | Tomaszow Mazowiecki, 97-200, Poland |
Withdrawn | Stacja Dializ Naklo nad Notecia | Naklo nad Notecia, 89-100, Poland |
Primary Outcome
- Cumulative incidence risk of the first composite of major bleeding (MB) and clinically-relevant non-major bleeding (CRNMB) events as assessed by blinded Central Independent Adjudication Committee (CIAC)Cumulative incidence risk of the first Composite of MB and CRNMB (ISTH) at month 6 is reported in the table. Descriptive time to composite of MB and CRNMB Events is reported in statistical analysis. Descriptive time to composite of treatment emergent major and CRNMB events [in alignment with International Society on Thrombosis and Haemostatsis (ISTH) guidelines] analyses were performed. The cumulative incidence function for the event-of-interest together with the corresponding confidence interval were estimated for each treatment arm using Aalen-Johansen estimators. Cumulative incidence of events up to the day, inclusive.date_rangeTime Frame:From the first dose of study intervention up till 30 days after last study intervention in the main treatment period, up to 6 months
- Cumulative incidence risk of composite of moderate and severe adverse events (AEs) and serious adverse events (SAEs)Cumulative incidence risk of composite of moderate and severe AEs and SAEs at month 6 is reported in the table. Descriptive time to the composite of Moderate and Severe AEs and SAEs is reported in statistical analysis. An AE was any untoward medical occurrence in a patient or clinical study participant, whether or not considered related to the study intervention.date_rangeTime Frame:From the first dose of study intervention up until 30 days after last study intervention in the main treatment period, up to 6 months
Secondary Outcome
- Ratio of activated partial thromboplastin time (aPTT) at 6 months trough levels versus baseline.The aPTT at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). aPTT was measured via the kaolin-trigger method (clotting assay).date_rangeTime Frame:At 6 months (Visit 19 / Day 30 of the 6th month)
- Ratio of Factor XI (FXI) activity at 6 months trough levels versus baselineThe Factor XI (FXI) activity at trough levels after 6 months were analyzed as ratio to baseline by providing the Geometric Mean (Standard Deviation). Factor XI activity was assessed with an aPTT-based coagulation test using FXI deficient plasma.date_rangeTime Frame:At 6 months (Visit 19 / Day 30 of the 6th month)
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
4