check_circleStudy Completed

End-stage renal disease, Prevention of thromboembolic events, Hemodialysis, Hemodiafiltration

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Participants must be at least 18 years of age
    - Patients with end-stage renal disease on hemodialysis (including hemodiafiltration) for ≥3 months, receiving dialysis at least 9 hours a week and stable in the view of the investigator
    - Body weight of at least 50 kg
    - Male and/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.

  • - Recent (<6 months before screening) clinically significant bleeding
    - Hemoglobin (Hb) < 9.0 g/dL at screening
    - Platelet count < 100 x 10^9/L
    - aPTT or PT > ULN (upper limit of normal)
    - Hepatic disease associated with ALT > 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20% of the total
    - Sustained uncontrolled hypertension (diastolic blood pressure ≥100 mmHg and/or systolic blood pressure ≥ 180 mmHg)
    - Known intracranial neoplasm, arteriovenous malformation or aneurysm
    - Known bleeding disorders e.g. von-Willebrand disease or Hemophilia A, B or C
    - 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 study participation
    - Scheduled living donor renal transplant during study participation
    - Persistent heart failure as classified by the New York Heart Association (NYHA) classification of 3 or higher
    - Receiving antiplatelet therapy except daily ASA ≤ 150 mg/day
    - Receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure

Trial summary

Enrollment Goal
704
Trial Dates
August 2020 - May 2022
Phase
Phase 2
Could I Receive a placebo
Yes
Products
Osocimab (BAY1213790)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
EpicuraBaudour, 7331, Belgium
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Completed
Hospital Clínico Universitario de Santiago de CompostelaSantiago de Compostela, 15706, Spain
Completed
Hospital Universitario Dr. PesetValencia, 46017, Spain
Completed
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, 00168, Italy
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
IRCCS Istituti Clinici Scientifici Maugeri SpA SBPavia, 27100, Italy
Completed
A.O.U. di Bologna Policlinico S.Orsola MalpighiBologna, 40138, Italy
Completed
Health Corporation of Galilee Medical CenterNahariya, 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 TaulíSabadell, 08208, Spain
Completed
Hospital Althaia, Xarxa Assistencial de ManresaManresa, 08243, Spain
Completed
Hospital Clinico Universitario San Carlos | NefrologiaMadrid, 28040, Spain
Completed
General Hospital of Athens LAIKOAthens, 11527, Greece
Completed
General Hospital of Thessaloniki PapageorgiouThessaloniki, 56403, Greece
Completed
Hippokration General Hospital of ThessalonikiThessaloniki, 54642, Greece
Completed
University General Hospital of LarissaLarissa, 41110, Greece
Completed
HIPPOKRATION General Hospital of AthensAthens, 115 27, Greece
Completed
Ioannina University General HospitalIoannina, 45500, Greece
Withdrawn
Hôpital Pasteur - NiceNICE, 06200, France
Withdrawn
Centre Hospitalier - ArrasArras, 62000, France
Completed
Krajska Nemocnice LiberecLiberec, 460 63, Czechia
Completed
Privamed s.r.o.Plzen, 323 33, Czechia
Completed
Fresenius Nephro Care s.r.o. - SokolovSokolov, 356 01, Czechia
Completed
Klinik Landstraße - Krankenhaus RudolfstiftungWien, 1030, Austria
Withdrawn
Medizinische Universität GrazGraz, 8036, Austria
Completed
Klinikum Klagenfurt am WörtherseeKlagenfurt, 9020, Austria
Completed
Universitätsklinikum AKH WienWien, 1090, Austria
Completed
Privatklinik Wehrle-DiakonissenSalzburg, 5026, Austria
Completed
Brovarskaya multidisciplinary clinical hospitalBrovary, 07400, Ukraine
Completed
Kyiv City Center of Nephrology and DialysisKyiv, 02660, Ukraine
Completed
Medical center LLC " Fresenius medical care Ukraine»Cherkasy, 18009, Ukraine
Completed
Regional Clinical Hospital - Ivano-FrankivskIvano-Frankivsk, 76000, Ukraine
Withdrawn
Private enterprise private production company " Acinus"Kropyvnytskyi, 25006, Ukraine
Completed
State Institution “Institute of Nephrology” NAMS of UkraineKyiv, 04050, Ukraine
Completed
Mykolaiv Regional Clinical HospitalMykolaiv, 54058, Ukraine
Completed
Vinnitsa Regional Clinical Hospital im. N.I. PirogovVinnytsia, 21018, Ukraine
Completed
Zaporizhzhia Regional Clinical HospitalZaporizhzhya, 69600, Ukraine
Completed
Transcarpatian Regional Clinical HospitalUzhgorod, 88018, Ukraine
Completed
Eurodial Obidos (DaVita)Gaeiras - Obidos, 2510-702, Portugal
Completed
CHLO - Hospital Santa CruzCarnaxide, 2795-53, Portugal
Completed
Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology DepartmentTorres Novas, 2350-754, Portugal
Completed
Diaverum AveiroAveiro, 3800-266, Portugal
Completed
Eurodial Leiria (DaVita)Leiria, 2400-441, Portugal
Completed
Van Buren Dialysis CenterRiverside, 92503, United States
Completed
A.O.U. di ParmaParma, 43126, Italy
Completed
IRCCS Ospedale Policlinico San MartinoGenova, 16132, Italy
Completed
AUSL-IRCCS di Reggio EmiliaReggio Emilia, 42123, Italy
Withdrawn
ASST LodiLodi, 26900, Italy
Completed
Caledial - Centro de Hemodialise de GaiaCanelas, 4410-313, Portugal
Completed
DaVita South Valley DialysisEncino, 91316, United States
Completed
North America Research Institute - AzusaAzusa, 91702, United States
Withdrawn
Groupe Hospitalier Sud - AmiensAmiens cedex 1, 80054, France
Withdrawn
Centre Hospitalier Universitaire-Hotel DieuNantes, 44093, France
Withdrawn
Hôpital TenonPARIS, 75020, France
Withdrawn
Hopital LapeyronieMontpellier Cedex 5, 34295, France
Withdrawn
Hôpital de la Maison Blanche - ReimsREIMS, 51092, France
Withdrawn
City Clinical Hospital of Emergency Care #1Omsk, 644112, Russian Federation
Completed
Sverdlovsk Regional Clinical Hospital #1Yekaterinburg, 620102, Russian Federation
Withdrawn
Regional Clinical Hospital KrasnoyarskKrasnoyarsk, 660022, Russian Federation
Completed
City Hospital #31St. Petersburg, 197110, Russian Federation
Completed
LLC Fresenius medical care KubanKrasnodar, 350029, Russian Federation
Completed
LLC B. Brown Avitum Russland ClinicsSt. Petersburg, 193318, Russian Federation
Completed
LLC Dialysis centerMytishchi, 141007, Russian Federation
Completed
LLC Dialysis centerKolomna, 140402, Russian Federation
Completed
LLC Yaroslavl dialysis centerYaroslavl, 150062, Russian Federation
Withdrawn
LLC Dialysis center Saint-PetersburgSaint-Petersburg, 194354, Russian Federation
Withdrawn
Nikolaevskaya HospitalSt. Petersburg, 198510, Russian Federation
Withdrawn
City Hospital #52Moscow, 123182, Russian Federation
Completed
Republican Hospital n.a. V.A. BaranovPetrozavodsk, 185019, Russian Federation
Completed
Fresenius Kidney Care Evergreen ParkEvergreen Park, 60805, United States
Completed
Hospital Universitari Germans Trias i PujolBadalona, 08916, Spain
Completed
Clalit Health Services Rabin Medical Center-Beilinson CampusPetah Tikva, 4941492, Israel
Completed
Shamir Medical Center (Assaf Harofeh)Zerifin, 7030000, Israel
Completed
Lady Davis Carmel Medical CenterHaifa, 3436212, Israel
Completed
Kharkiv regional Clinical Centre of urology and nephrologyKharkiv, 61037, Ukraine
Completed
Academisch Medisch Centrum (AMC)AMSTERDAM, 1105 AZ, Netherlands
Completed
Albert Schweitzer Ziekenhuis, DordwijkDORDRECHT, 3318 AT, Netherlands
Withdrawn
Klaipeda Republican HospitalKlaipeda, LT-92231, Lithuania
Completed
DaVita Butler Farm DialysisHampton, 23666, United States
Completed
ARA Holyoke Dialysis CenterHolyoke, 01040, United States
Completed
East L.A. Dialysis CenterLos Angeles, 90022, United States
Completed
Deventer ZiekenhuisDEVENTER, 7416 SE, Netherlands
Withdrawn
Vilnius University Hospital Santaros KlinikosVilnius, LT-08661, Lithuania
Completed
Imeldaziekenhuis - St-ElisabethkliniekBonheiden, 2820, Belgium
Completed
AZ Nikolaas Campus Sint-NiklaasSINT-NIKLAAS, 9100, Belgium
Completed
CHU de Liege | CHR Citadel - Department of NephrologyLIEGE, 4000, Belgium
Completed
LUHS Kauno Hospital (Josvainiu str.)Kaunas, LT-47116, Lithuania
Completed
Liberty Dialysis- CaldwellCaldwell, 83605, United States
Withdrawn
DaVita College Park DialysisWoodlands, 77384, United States
Withdrawn
Westover DialysisSan Antonio, 78251, United States
Completed
Queen’s Dialysis UnitWest Covina, 91790, United States
Completed
NephroCare APDPLisboa, 1250-191, Portugal
Completed
Pluribus Dialise - Cascais (DaVita)Cascais, 2750-663, Portugal
Withdrawn
Peking University First HospitalBeijing, 100034, China
Completed
Davita Hospital Hill DialysisKansas City, 64108, United States
Completed
Fresenius Kidney Care South DialysisShreveport, 71106, United States
Completed
Waterloo DialysisAustin, 78756, United States
Completed
Durham Nephrology Associates, PaDurham, 27704, United States
Completed
Stacja Dializ W-wa MangaliaWarszawa, 02-758, Poland
Completed
NZOZ Nowy Szpital w Swieciu Sp. z o.o.Swiecie, 86-100, Poland
Completed
Stacja Dializ OlkuszOlkusz, 32-300, Poland
Withdrawn
Stacja Dializ BrzegBrzeg, 49-301, Poland
Completed
Stacja Dializ ZyrardowZyrardow, 96-300, Poland
Completed
Maasstad Ziekenhuis | Neurology DepartmentRotterdam, 3079DZ, Netherlands
Withdrawn
MHAT Dr. Bratan Shukerov ADSmolyan, 4700, Bulgaria
Withdrawn
MHAT DobrichDobrich, 9300, Bulgaria
Withdrawn
Acibadem City Clinic Multiprofile Hospital for Active TreatmSofia, 1407, Bulgaria
Completed
UMHAT Kanev ADRuse, 7002, Bulgaria
Withdrawn
Multiprofile Hospital for Active Treatment Sv. AnnaVarna, 9000, Bulgaria
Completed
MHAT Sveti Ivan Rilski 2003Dupnitsa, 2600, Bulgaria
Completed
MHAT HaskovoHaskovo, 6300, Bulgaria
Completed
Multiprofile Hospital for Active Treatment Hristo Botev ADVratsa, 3000, Bulgaria
Completed
Keszthelyi KorhazKeszthely, 8360, Hungary
Completed
Bajai Szent Rokus KorhazBaja, 6500, Hungary
Completed
Csongrad Megyei Egeszsegugyi Ellato Kozpont,HodmezovasarhelyHodmezovasarhely, 6800, Hungary
Completed
Fresenius Medical Care Egeszsegugyi Kft.Pecs, 7624, Hungary
Completed
Fresenius Medical Care Egeszsegugyi Kft.Budapest, 1083, Hungary
Withdrawn
Huashan Hospital, Fudan UniversityShanghai, 200040, China
Withdrawn
West China Hospital Sichuan UniversityChengdu, 610041, China
Completed
Saiyu ClinicKoshigaya, 343-0823, Japan
Completed
Kikuchi Medical ClinicTsukuba, 305-0861, Japan
Completed
Akagaki ClinicOsaka, 543-0052, Japan
Completed
Saint Hill HospitalUbe, 755-0155, Japan
Completed
Katta General HospitalShiraishi, 989-0231, Japan
Completed
Ohishi Naika ClinicTsuchiura, 300-0835, Japan
Completed
Kyoto Station Takeda Dialysis ClinicKyoto, 600-8216, Japan
Withdrawn
Chibana ClinicOkinawa, 904-2143, Japan
Completed
Nagaoka Red Cross HospitalNagaoka, 940-2085, Japan
Completed
Ibaraki Seinan Medical Center HospitalSashima-gun, 306-0433, Japan
Completed
FMC San YsidroSan Diego, 92154, United States
Completed
Liberty Dialysis St. GeorgeSt. George, 84790, United States
Completed
Fresenius Kidney Care Baton Rouge Mancuso LaneBaton Rouge, 70808, United States
Completed
Fresenius Kidney Care - La MesaLa Mesa, 91942, United States
Completed
ARA Plantation Dialysis, LLCEllenton, 34222, United States
Withdrawn
Midwest Nephrology Group, PLLCMidwest City, 73130, United States
Completed
Fresenius Kidney Care Sugar LandSugar Land, 77479, United States
Completed
ARA AugustaAugusta, 30901, United States
Completed
Renal Medicine AssociatesAlbuquerque, 87109, United States
Completed
DaVita Greater Waterbury DialysisWaterbury, 06708, United States
Completed
Fresenius Kidney Care Kearny MesaSan Diego, 92111, United States
Withdrawn
FMC-AllentownAllentown, 18103, United States
Completed
Fresenius North Austin Dialysis CenterAustin, 78758, United States
Withdrawn
Fresenius Medical Care - Central San AntonioSan Antonio, 78207, United States
Completed
Fresenius Kidney Care – Mission Bend (FMCNA #3971)Houston, 77083, United States
Completed
Yabuki HospitalYamagata, 990-0885, Japan
Completed
Akebono ClinicKumamoto, 861-4112, Japan
Completed
Fresenius Medical Care Egeszsegugyi Kft.Miskolc, 3526, Hungary
Completed
AZ St-Lucas Campus St-Lucasgent, 9000, Belgium
Withdrawn
Centre Hospitalier de Wallonie picardeTournai, 7500, Belgium
Completed
Catharina ZiekenhuisEINDHOVEN, 5623 EJ, Netherlands
Completed
Takemura Medical Nephro ClinicKanuma, 322-0029, Japan
Completed
Futakotamagawaekimae clinicSetagaya-ku, 158-0094, Japan
Completed
Tsuchiura Beryl ClinicTsuchiura, 300-0062, Japan
Withdrawn
Hopital de la Conception - MarseilleMARSEILLE, 13005, France
Withdrawn
Hôpital Civil - StrasbourgSTRASBOURG, 67091, France
Completed
Fakultni nemocnice OstravaOstrava, 708 52, Czechia
Completed
Lutsk city clinical hospitalLutsk, 43024, Ukraine
Withdrawn
Regional Clinical Hospital-LvivLviv, 79000, Ukraine
Withdrawn
Ukrainska Medychna Stomatologichna AkademiiaPoltava, 314039, Ukraine
Completed
Kocaeli Universitesi Tip FakultesiKocaeli, 41380, Turkey
Completed
Hacettepe Universitesi Tip FakultesiAnkara, 06230, Turkey
Completed
Turk Bobrek Vakfi Memorial Hizmet HastanesiIstanbul, 34180, Turkey
Completed
Erciyes Universitesi Tip FakultesiKayseri, 38039, Turkey
Completed
Inonu Universitesi Tip FakultesiMalatya, 44280, Turkey
Completed
Adnan Menderes Universitesi Tip fakultesiAydin, 09100, Turkey
Completed
Sisli Hamidiye Etfal Egitim ve Arastirma HastanesiIstanbul, 34418, Turkey
Withdrawn
Bukovinian State Medical Academy RegionalChernivtsi, 58000, Ukraine
Withdrawn
SP Szpital Klilniczny im. MieleckiegoKatowice, 40-027, Poland
Completed
Wojewodzki Szpital ZespolonyKielce, 25-736, Poland
Withdrawn
Centrum Dializ Fresenius Tarnowskie GoryTarnowskie Gory, 42-612, Poland
Completed
Fresenius Kidney Care - BrawleyBrawley, 92227, United States
Completed
Kupchinsky center for outpatient dialysisSt. Petersburg, 192102, Russian Federation
Completed
Chelyabinsk Regional Clinical HospitalChelyabinsk, 454076, Russian Federation
Completed
City Clinical Hospital #1 OrenburgOrenburg, 460040, Russian Federation
Completed
Dnepropetrovsk regional hospital n.a. I. I. MechnikovDnipro, 49005, Ukraine
Completed
Pluribus Dialise - Sacavem (DaVita)Sacavem, 2685-005, Portugal
Completed
John Hunter HospitalNew Lambton Heights, 2305, Australia
Withdrawn
Monash Medical CentreClayton, 3168, Australia
Withdrawn
Gold Coast University HospitalSouthport, 4215, Australia
Completed
Eastern Health Integrated Renal ServiceBox Hill, 3128, Australia
Completed
Sydney Adventist HospitalWahroonga, 2076, Australia
Withdrawn
Zhongda Hospital Southeast UniversityNanjing, 210009, China
Withdrawn
Peking University Shenzhen HospitalShenzhen, 518036, China
Withdrawn
SichuanAcademyofMedicalSciences&SichuanProvincialPeople'sHosChengdu, 610072, China
Completed
Eszak-Pesti Centrumkorhaz-HonvedkorhazBudapest, 1134, Hungary
Completed
General Hospital of ArtaArta, 47100, Greece
Withdrawn
S.C. Avitum SRL - Centrul dializa Avitum ResitaResita, 320167, Romania
Withdrawn
Diaverum Romania SRL BucurestiBucharest, 060044, Romania
Withdrawn
Diaverum Romania SRL CraiovaCraiova, 200349, Romania
Completed
SPD - Amadora (Diaverum Amadora)Amadora, 2700-001, Portugal
Completed
Westmead HospitalWestmead, 2145, Australia
Completed
MHAT Shumen ADShumen, 9700, Bulgaria
Completed
Gelre ZiekenhuizenAPELDOORN, 7334 DZ, Netherlands
Withdrawn
St. Martyr Elizaveta HospitalSt. Petersburg, 195257, Russian Federation
Withdrawn
S.C. Avitum SRLTârgu Jiu, 210146, Romania
Withdrawn
Diaverum Romania SRLBucharest, 032895, Romania
Withdrawn
Diaverum Romania SRL OradeaOradea, 410562, Romania
Withdrawn
Institute of Diabetology N. PaulescuBucuresti, 020475, Romania
Withdrawn
Fundeni Clinical InstituteBucuresti, 022328, Romania
Completed
Rabin Medical Center, HaSharon (Golda) CampusPetach Tikva, 4937211, Israel
Completed
Poltava Regional Clinical Hospital n.a. M.V. SkliphosovskyiPoltava, 36011, Ukraine
Withdrawn
Stacja Dializ LegnicaLegnica, 59-220, Poland
Withdrawn
Stacja Dializ Tomaszow MazowieckiTomaszow Mazowiecki, 97-200, Poland
Withdrawn
Stacja Dializ Naklo nad NoteciaNaklo 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 baseline
    The 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

A randomized, double-blind, parallel group, placebo-controlled, multi-center study to assess the safety and tolerability of monthly subcutaneous administrations of a low and high dose cohort of osocimab to ESRD patients on regular hemodialysis
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
4