Trial Condition(s):
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 (CONVERT)
Bayer Identifier:
20115
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
In this study researchers want to learn about the safety of drug Osocimab at low and high 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 low or high 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.
Inclusion Criteria
- 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.
Exclusion Criteria
- Recent (<6 months before screening) clinically significant bleeding - Hemoglobin (Hb) < 9.0 g/dL at screening - Platelet count < 100 x 109/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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Epicura Baudour, Belgium, 7331 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Dr. Peset Valencia, Spain, 46017 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Istituti Clinici Scientifici Maugeri SpA SB Pavia, Italy, 27100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Health Corporation of Galilee Medical Center Nahariya, Israel, 2210001 | Status Completed | Contact Us: E-mail: clinical-tria[email protected] Phone: (+)1-888-84 22937 |
Locations Poriya Medical Center | Nephrology and Hypertension Dept. Tiberius, Israel, 1528001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Barzilai Medical Center | Nephrology & Hypertension Dept. Ashkelon, Israel, 7830604 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Corporació Sanitària Parc Taulí Sabadell, Spain, 08208 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Althaia, Xarxa Assistencial de Manresa Manresa, Spain, 08243 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico Universitario San Carlos | Nefrologia Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital of Athens LAIKO Athens, Greece, 11527 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital of Thessaloniki Papageorgiou Thessaloniki, Greece, 56403 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hippokration General Hospital of Thessaloniki Thessaloniki, Greece, 54642 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Larissa Larissa, Greece, 41110 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HIPPOKRATION General Hospital of Athens Athens, Greece, 115 27 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ioannina University General Hospital Ioannina, Greece, 45500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krajska Nemocnice Liberec a.s. Liberec, Czech Republic, 460 63 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Privamed s.r.o. Plzen, Czech Republic, 323 33 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Nephro Care s.r.o. - Sokolov Sokolov, Czech Republic, 356 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Landstraße - Krankenhaus Rudolfstiftung Wien, Austria, 1030 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Klagenfurt am Wörthersee Klagenfurt, Austria, 9020 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Privatklinik Wehrle-Diakonissen Salzburg, Austria, 5026 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Brovarskaya multidisciplinary clinical hospital Brovary, Ukraine, 07400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyiv City Center of Nephrology and Dialysis Kyiv, Ukraine, 02660 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical center LLC " Fresenius medical care Ukraine» Cherkasy, Ukraine, 18009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regional Clinical Hospital - Ivano-Frankivsk Ivano-Frankivsk, Ukraine, 76000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations State Institution “Institute of Nephrology” NAMS of Ukraine Kyiv, Ukraine, 04050 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mykolaiv Regional Clinical Hospital Mykolaiv, Ukraine, 54058 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vinnitsa Regional Clinical Hospital im. N.I. Pirogov Vinnytsia, Ukraine, 21018 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zaporizhzhia Regional Clinical Hospital Zaporizhzhya, Ukraine, 69600 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Transcarpatian Regional Clinical Hospital Uzhgorod, Ukraine, 88018 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eurodial Obidos (DaVita) Gaeiras - Obidos, Portugal, 2510-702 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHLO - Hospital Santa Cruz Carnaxide, Portugal, 2795-53 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHMT - Hospital Rainha Santa Isabel - Servico de Nefrologia Torres Novas, Portugal, 2350-754 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diaverum Aveiro Aveiro, Portugal, 3800-266 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eurodial Leiria (DaVita) Leiria, Portugal, 2400-441 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Van Buren Dialysis Center Riverside, United States, 92503 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Parma Parma, Italy, 43126 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Policlinico San Martino Genova, Italy, 16132 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL-IRCCS di Reggio Emilia Reggio Emilia, Italy, 42123 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Caledial - Centro de Hemodialise de Gaia Canelas, Portugal, 4410-313 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita South Valley Dialysis Encino, United States, 91316 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations North America Research Institute - Azusa Azusa, United States, 91702 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sverdlovsk Regional Clinical Hospital #1 Yekaterinburg, Russia, 620102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Hospital #31 St. Petersburg, Russia, 197110 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Fresenius medical care Kuban Krasnodar, Russia, 350029 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC B. Brown Avitum Russland Clinics St. Petersburg, Russia, 193318 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Dialysis center Mytishchi, Russia, 141007 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Dialysis center Kolomna, Russia, 140402 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Yaroslavl dialysis center Yaroslavl, Russia, 150062 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Republican Hospital n.a. V.A. Baranov Petrozavodsk, Russia, 185019 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care Evergreen Park Evergreen Park, United States, 60805 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva, Israel, 4941492 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shamir Medical Center (Assaf Harofeh) Zerifin, Israel, 7030000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lady Davis Carmel Medical Center Haifa, Israel, 3436212 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kharkiv regional Clinical Centre of urology and nephrology Kharkiv, Ukraine, 61037 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academisch Medisch Centrum (AMC) AMSTERDAM, Netherlands, 1105 AZ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Ziekenhuis, Locatie Dordwijk DORDRECHT, Netherlands, 3318 AT | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Butler Farm Dialysis Hampton, United States, 23666 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ARA Holyoke Dialysis Center Holyoke, United States, 01040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations East L.A. Dialysis Center Los Angeles, United States, 90022 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Deventer Ziekenhuis DEVENTER, Netherlands, 7416 SE | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Imeldaziekenhuis - St-Elisabethkliniek BONHEIDEN, Belgium, 2820 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Nikolaas Campus Sint-Niklaas SINT-NIKLAAS, Belgium, 9100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Liege | CHR Citadel - Department of Nephrology LIEGE, Belgium, 4000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LUHS Kauno Hospital (Josvainiu str.) Kaunas, Lithuania, LT-47116 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liberty Dialysis- Caldwell Caldwell, United States, 83605 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen’s Dialysis Unit West Covina, United States, 91790 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NephroCare APDP Lisboa, Portugal, 1250-191 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pluribus Dialise - Cascais (DaVita) Cascais, Portugal, 2750-663 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Davita Hospital Hill Dialysis Kansas City, United States, 64108 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care South Dialysis Shreveport, United States, 71106 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Waterloo Dialysis Austin, United States, 78756 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Durham Nephrology Associates, Pa Durham, United States, 27704 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stacja Dializ W-wa Mangalia Warszawa, Poland, 02-758 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NZOZ Nowy Szpital w Swieciu Sp. z o.o. Swiecie, Poland, 86-100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stacja Dializ Olkusz Olkusz, Poland, 32-300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stacja Dializ Zyrardow Zyrardow, Poland, 96-300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maasstad Ziekenhuis ROTTERDAM, Netherlands, 3079 DZ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Kanev AD Ruse, Bulgaria, 7002 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Sveti Ivan Rilski 2003 Dupnitsa, Bulgaria, 2600 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Haskovo Haskovo, Bulgaria, 6300 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Active Treatment Hristo Botev AD Vratsa, Bulgaria, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Keszthelyi Korhaz Keszthely, Hungary, 8360 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bajai Szent Rokus Korhaz Baja, Hungary, 6500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely Hodmezovasarhely, Hungary, 6800 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care Egeszsegugyi Kft. Pecs, Hungary, 7624 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care Egeszsegugyi Kft. Budapest, Hungary, 1083 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiyu Clinic Koshigaya, Japan, 343-0823 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kikuchi Medical Clinic Tsukuba, Japan, 305-0861 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akagaki Clinic Osaka, Japan, 543-0052 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saint Hill Hospital Ube, Japan, 755-0155 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Katta General Hospital Shiraishi, Japan, 989-0231 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ohishi Naika Clinic Tsuchiura, Japan, 300-0835 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyoto Station Takeda Dialysis Clinic Kyoto, Japan, 600-8216 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagaoka Red Cross Hospital Nagaoka, Japan, 940-2085 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ibaraki Seinan Medical Center Hospital Sashima-gun, Japan, 306-0433 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FMC San Ysidro San Diego, United States, 92154 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liberty Dialysis St. George St. George, United States, 84790 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care Baton Rouge Mancuso Lane Baton Rouge, United States, 70808 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care - La Mesa La Mesa, United States, 91942 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ARA Plantation Dialysis, LLC Ellenton, United States, 34222 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care Sugar Land Sugar Land, United States, 77479 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ARA Augusta Augusta, United States, 30901 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Renal Medicine Associates Albuquerque, United States, 87109 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Greater Waterbury Dialysis Waterbury, United States, 06708 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care Kearny Mesa San Diego, United States, 92111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius North Austin Dialysis Center Austin, United States, 78758 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care – Mission Bend (FMCNA #3971) Houston, United States, 77083 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yabuki Hospital Yamagata, Japan, 990-0885 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akebono Clinic Kumamoto, Japan, 861-4112 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care Egeszsegugyi Kft. Miskolc, Hungary, 3526 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ St-Lucas Campus St-Lucas GENT, Belgium, 9000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Catharina Ziekenhuis EINDHOVEN, Netherlands, 5623 EJ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Takemura Medical Nephro Clinic Kanuma, Japan, 322-0029 | Status Completed | Contact Us: E-mail: clinical-[email protected] Phone: (+)1-888-84 22937 |
Locations Futakotamagawaekimae clinic Setagaya-ku, Japan, 158-0094 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tsuchiura Beryl Clinic Tsuchiura, Japan, 300-0062 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Ostrava Ostrava, Czech Republic, 708 52 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lutsk city clinical hospital Lutsk, Ukraine, 43024 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kocaeli Universitesi Tip Fakultesi Kocaeli, Turkey, 41380 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hacettepe Universitesi Tip Fakultesi Ankara, Turkey, 06230 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Turk Bobrek Vakfi Memorial Hizmet Hastanesi Istanbul, Turkey, 34180 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Erciyes Universitesi Tip Fakultesi Kayseri, Turkey, 38039 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inonu Universitesi Tip Fakultesi Malatya, Turkey, 44280 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Adnan Menderes Universitesi Tip fakultesi Aydin, Turkey, 09100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi Istanbul, Turkey, 34418 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wojewodzki Szpital Zespolony Kielce, Poland, 25-736 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care - Brawley Brawley, United States, 92227 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kupchinsky center for outpatient dialysis St. Petersburg, Russia, 192102 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chelyabinsk Regional Clinical Hospital Chelyabinsk, Russia, 454076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Clinical Hospital #1 Orenburg Orenburg, Russia, 460040 | Status Completed | Contact Us: E-mail: clinical-trials-c[email protected] Phone: (+)1-888-84 22937 |
Locations Dnepropetrovsk regional hospital n.a. I. I. Mechnikov Dnipro, Ukraine, 49005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pluribus Dialise - Sacavem (DaVita) Sacavem, Portugal, 2685-005 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations John Hunter Hospital New Lambton Heights, Australia, 2305 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Health Integrated Renal Service Box Hill, Australia, 3128 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sydney Adventist Hospital Wahroonga, Australia, 2076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Magyar Honvedseg Egeszsegugyi Kozpont Budapest, Hungary, 1134 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital of Arta Arta, Greece, 47100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SPD - Amadora (Diaverum Amadora) Amadora, Portugal, 2700-001 | Status Completed | Contact Us: E-mail: clinical-trials-con[email protected] Phone: (+)1-888-84 22937 |
Locations Westmead Hospital Westmead, Australia, 2145 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Shumen AD Shumen, Bulgaria, 9700 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gelre Ziekenhuizen APELDOORN, Netherlands, 7334 DZ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rabin Medical Center, HaSharon (Golda) Campus Petach Tikva, Israel, 4937211 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi Poltava, Ukraine, 36011 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
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
Primary Outcome
- Composite of major and clinically-relevant non-major bleeding events as assessed by blinded Central Independent Adjudication Committee (CIAC)Timeframe: From the first dose at month 1 and up to 6 months
- Composite of moderate and severe adverse ( AEs) and serious adverse events (SAEs)Timeframe: From the first dose at month 1 and up to 6 months
Secondary Outcome
- Activated partial thromboplastin time (aPTT) at trough levelsaPTT will be measuredTimeframe: At baseline and after 6 months
- Factor XIa (FXIa) activity at trough levelsFactor XI activity will be assessedTimeframe: At baseline and after 6 months
Additional Information
Not Available
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