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Clinical Trial Details

Trial ID: L1503
Source ID: NCT04523220
Associated Drug: Bay1213790 (Osocimab)
Title: Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis
Acronym: CONVERT
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT04523220/results
Conditions: End-stage Renal Disease|Prevention of Thromboembolic Events|Hemodialysis|Hemodiafiltration
Interventions: DRUG: BAY1213790 (Osocimab)|DRUG: Placebo
Outcome Measures: Primary: 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., 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., 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: 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)., 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., At 6 months (Visit 19 / Day 30 of the 6th month)
Sponsor/Collaborators: Sponsor: Bayer
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 704
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2020-08-28
Completion Date: 2022-05-30
Results First Posted: 2023-07-21
Last Update Posted: 2023-07-21
Locations: North America Research Institute - Azusa, Azusa, California, 91702, United States|Fresenius Kidney Care - Brawley, Brawley, California, 92227, United States|DaVita South Valley Dialysis, Encino, California, 91316, United States|Fresenius Kidney Care - La Mesa, La Mesa, California, 91942, United States|East L.A. Dialysis Center, Los Angeles, California, 90022, United States|Van Buren Dialysis Center, Riverside, California, 92503, United States|Fresenius Kidney Care Kearny Mesa, San Diego, California, 92111, United States|FMC San Ysidro, San Diego, California, 92154, United States|Queen's Dialysis Unit, West Covina, California, 91790, United States|DaVita Greater Waterbury Dialysis, Waterbury, Connecticut, 06708, United States|ARA Plantation Dialysis, LLC, Ellenton, Florida, 34222, United States|ARA Augusta, Augusta, Georgia, 30901, United States|Liberty Dialysis- Caldwell, Caldwell, Idaho, 83605, United States|Fresenius Kidney Care Evergreen Park, Evergreen Park, Illinois, 60805, United States|Fresenius Kidney Care Baton Rouge Mancuso Lane, Baton Rouge, Louisiana, 70808, United States|Fresenius Kidney Care South Dialysis, Shreveport, Louisiana, 71106, United States|ARA Holyoke Dialysis Center, Holyoke, Massachusetts, 01040, United States|Davita Hospital Hill Dialysis, Kansas City, Missouri, 64108, United States|Renal Medicine Associates, Albuquerque, New Mexico, 87109, United States|Durham Nephrology Associates, Pa, Durham, North Carolina, 27704, United States|Waterloo Dialysis, Austin, Texas, 78756, United States|Fresenius North Austin Dialysis Center, Austin, Texas, 78758, United States|Fresenius Kidney Care - Mission Bend (FMCNA #3971), Houston, Texas, 77083, United States|Fresenius Kidney Care Sugar Land, Sugar Land, Texas, 77479, United States|Liberty Dialysis St. George, Saint George, Utah, 84790, United States|DaVita Butler Farm Dialysis, Hampton, Virginia, 23666, United States|Sydney Adventist Hospital, Wahroonga, New South Wales, 2076, Australia|Westmead Hospital, Westmead, New South Wales, 2145, Australia|Eastern Health Integrated Renal Service, Box Hill, 3128, Australia|John Hunter Hospital, New Lambton Heights, 2305, Australia|Klinikum Klagenfurt am Wörthersee, Klagenfurt, Kärnten, 9020, Austria|Privatklinik Wehrle-Diakonissen, Salzburg, 5026, Austria|Klinik Landstraße - Krankenhaus Rudolfstiftung, Wien, 1030, Austria|Universitätsklinikum AKH Wien, Wien, 1090, Austria|Epicura, Baudour, 7331, Belgium|Imeldaziekenhuis - St-Elisabethkliniek, Bonheiden, 2820, Belgium|AZ St-Lucas Campus St-Lucas, Gent, 9000, Belgium|UZ Leuven Gasthuisberg, Leuven, 3000, Belgium|CHU de Liege | CHR Citadel - Department of Nephrology, Liege, 4000, Belgium|AZ Nikolaas Campus Sint-Niklaas, Sint-niklaas, 9100, Belgium|MHAT Sveti Ivan Rilski 2003, Dupnitsa, 2600, Bulgaria|MHAT Haskovo, Haskovo, 6300, Bulgaria|UMHAT Kanev AD, Ruse, 7002, Bulgaria|MHAT Shumen AD, Shumen, 9700, Bulgaria|Multiprofile Hospital for Active Treatment Hristo Botev AD, Vratsa, 3000, Bulgaria|Krajska Nemocnice Liberec, Liberec, 460 63, Czechia|Fakultni nemocnice Ostrava, Ostrava, 708 52, Czechia|Privamed s.r.o., Plzen, 323 33, Czechia|Fresenius Nephro Care s.r.o. - Sokolov, Sokolov, 356 01, Czechia|General Hospital of Arta, Arta, 47100, Greece|HIPPOKRATION General Hospital of Athens, Athens, 115 27, Greece|General Hospital of Athens LAIKO, Athens, 11527, Greece|Ioannina University General Hospital, Ioannina, 45500, Greece|University General Hospital of Larissa, Larissa, 41110, Greece|Hippokration General Hospital of Thessaloniki, Thessaloniki, 54642, Greece|General Hospital of Thessaloniki Papageorgiou, Thessaloniki, 56403, Greece|Bajai Szent Rokus Korhaz, Baja, 6500, Hungary|Fresenius Medical Care Egeszsegugyi Kft., Budapest, 1083, Hungary|Eszak-Pesti Centrumkorhaz-Honvedkorhaz, Budapest, 1134, Hungary|Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely, Hodmezovasarhely, 6800, Hungary|Keszthelyi Korhaz, Keszthely, 8360, Hungary|Fresenius Medical Care Egeszsegugyi Kft., Miskolc, 3526, Hungary|Fresenius Medical Care Egeszsegugyi Kft., Pecs, 7624, Hungary|Barzilai Medical Center | Nephrology & Hypertension Dept., Ashkelon, 7830604, Israel|Lady Davis Carmel Medical Center, Haifa, 3436212, Israel|Health Corporation of Galilee Medical Center, Nahariya, 2210001, Israel|Rabin Medical Center, HaSharon (Golda) Campus, Petach Tikva, 4937211, Israel|Clalit Health Services Rabin Medical Center-Beilinson Campus, Petah Tikva, 4941492, Israel|Poriya Medical Center | Nephrology and Hypertension Dept., Tiberius, 1528001, Israel|Shamir Medical Center (Assaf Harofeh), Zerifin, 7030000, Israel|A.O.U. di Bologna Policlinico S.Orsola Malpighi, Bologna, Emilia-Romagna, 40138, Italy|A.O.U. di Parma, Parma, Emilia-Romagna, 43126, Italy|AUSL-IRCCS di Reggio Emilia, Reggio Emilia, Emilia-Romagna, 42123, Italy|Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Lazio, 00168, Italy|IRCCS Ospedale Policlinico San Martino, Genova, Liguria, 16132, Italy|IRCCS Istituti Clinici Scientifici Maugeri SpA SB, Pavia, Lombardia, 27100, Italy|A.O.U. Careggi, Firenze, Toscana, 50134, Italy|Ibaraki Seinan Medical Center Hospital, Sashima-gun, Ibaraki, 306-0433, Japan|Tsuchiura Beryl Clinic, Tsuchiura, Ibaraki, 300-0062, Japan|Ohishi Naika Clinic, Tsuchiura, Ibaraki, 300-0835, Japan|Kikuchi Medical Clinic, Tsukuba, Ibaraki, 305-0861, Japan|Katta General Hospital, Shiraishi, Miyagi, 989-0231, Japan|Nagaoka Red Cross Hospital, Nagaoka, Niigata, 940-2085, Japan|Saiyu Clinic, Koshigaya, Saitama, 343-0823, Japan|Takemura Medical Nephro Clinic, Kanuma, Tochigi, 322-0029, Japan|Futakotamagawaekimae clinic, Setagaya-ku, Tokyo, 158-0094, Japan|Saint Hill Hospital, Ube, Yamaguchi, 755-0155, Japan|Akebono Clinic, Kumamoto, 861-4112, Japan|Kyoto Station Takeda Dialysis Clinic, Kyoto, 600-8216, Japan|Akagaki Clinic, Osaka, 543-0052, Japan|Yabuki Hospital, Yamagata, 990-0885, Japan|LUHS Kauno Hospital (Josvainiu str.), Kaunas, LT-47116, Lithuania|Academisch Medisch Centrum (AMC), Amsterdam, 1105 AZ, Netherlands|Gelre Ziekenhuizen, Apeldoorn, 7334 DZ, Netherlands|Deventer Ziekenhuis, Deventer, 7416 SE, Netherlands|Albert Schweitzer Ziekenhuis, Dordwijk, Dordrecht, 3318 AT, Netherlands|Catharina Ziekenhuis, Eindhoven, 5623 EJ, Netherlands|Maasstad Ziekenhuis | Neurology Department, Rotterdam, 3079DZ, Netherlands|Wojewodzki Szpital Zespolony, Kielce, 25-736, Poland|Stacja Dializ Olkusz, Olkusz, 32-300, Poland|NZOZ Nowy Szpital w Swieciu Sp. z o.o., Swiecie, 86-100, Poland|Stacja Dializ W-wa Mangalia, Warszawa, 02-758, Poland|Stacja Dializ Zyrardow, Zyrardow, 96-300, Poland|Eurodial Obidos (DaVita), Gaeiras - Obidos, Leiria, 2510-702, Portugal|SPD - Amadora (Diaverum Amadora), Amadora, Lisboa, 2700-001, Portugal|CHLO - Hospital Santa Cruz, Carnaxide, Lisboa, 2795-53, Portugal|Pluribus Dialise - Cascais (DaVita), Cascais, Lisboa, 2750-663, Portugal|Pluribus Dialise - Sacavem (DaVita), Sacavem, Lisboa, 2685-005, Portugal|Caledial - Centro de Hemodialise de Gaia, Canelas, Porto, 4410-313, Portugal|Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department, Torres Novas, Santarém, 2350-754, Portugal|Diaverum Aveiro, Aveiro, 3800-266, Portugal|Eurodial Leiria (DaVita), Leiria, 2400-441, Portugal|NephroCare APDP, Lisboa, 1250-191, Portugal|Chelyabinsk Regional Clinical Hospital, Chelyabinsk, 454076, Russian Federation|LLC Dialysis center, Kolomna, 140402, Russian Federation|LLC Fresenius medical care Kuban, Krasnodar, 350029, Russian Federation|LLC Dialysis center, Mytishchi, 141007, Russian Federation|City Clinical Hospital #1 Orenburg, Orenburg, 460040, Russian Federation|Republican Hospital n.a. V.A. Baranov, Petrozavodsk, 185019, Russian Federation|Kupchinsky center for outpatient dialysis, St. Petersburg, 192102, Russian Federation|LLC B. Brown Avitum Russland Clinics, St. Petersburg, 193318, Russian Federation|City Hospital #31, St. Petersburg, 197110, Russian Federation|LLC Yaroslavl dialysis center, Yaroslavl, 150062, Russian Federation|Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg, 620102, Russian Federation|Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, A Coruña, 15706, Spain|Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, 08916, Spain|Hospital Althaia, Xarxa Assistencial de Manresa, Manresa, Barcelona, 08243, Spain|Corporació Sanitària Parc Taulí, Sabadell, Barcelona, 08208, Spain|Hospital Clinico Universitario San Carlos | Nefrologia, Madrid, 28040, Spain|Hospital Clínico Universitario de Valencia, Valencia, 46010, Spain|Hospital Universitario Dr. Peset, Valencia, 46017, Spain|Hacettepe Universitesi Tip Fakultesi, Ankara, 06230, Turkey|Adnan Menderes Universitesi Tip fakultesi, Aydin, 09100, Turkey|Turk Bobrek Vakfi Memorial Hizmet Hastanesi, Istanbul, 34180, Turkey|Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi, Istanbul, 34418, Turkey|Erciyes Universitesi Tip Fakultesi, Kayseri, 38039, Turkey|Kocaeli Universitesi Tip Fakultesi, Kocaeli, 41380, Turkey|Inonu Universitesi Tip Fakultesi, Malatya, 44280, Turkey|Brovarskaya multidisciplinary clinical hospital, Brovary, 07400, Ukraine|Medical center LLC " Fresenius medical care Ukraine", Cherkasy, 18009, Ukraine|Dnepropetrovsk regional hospital n.a. I. I. Mechnikov, Dnipro, 49005, Ukraine|Regional Clinical Hospital - Ivano-Frankivsk, Ivano-Frankivsk, 76000, Ukraine|Kharkiv regional Clinical Centre of urology and nephrology, Kharkiv, 61037, Ukraine|Kyiv City Center of Nephrology and Dialysis, Kyiv, 02660, Ukraine|State Institution "Institute of Nephrology" NAMS of Ukraine, Kyiv, 04050, Ukraine|Lutsk city clinical hospital, Lutsk, 43024, Ukraine|Mykolaiv Regional Clinical Hospital, Mykolaiv, 54058, Ukraine|Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi, Poltava, 36011, Ukraine|Transcarpatian Regional Clinical Hospital, Uzhgorod, 88018, Ukraine|Vinnitsa Regional Clinical Hospital im. N.I. Pirogov, Vinnytsia, 21018, Ukraine|Zaporizhzhia Regional Clinical Hospital, Zaporizhzhya, 69600, Ukraine
URL: https://clinicaltrials.gov/show/NCT04523220

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress