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 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.
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 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Epicura Baudour, Belgium, 7331 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Valencia Valencia, Spain, 46010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Dr. Peset Valencia, Spain, 46017 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fondazione Policlinico Universitario Agostino Gemelli IRCCS Roma, Italy, 00168 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Istituti Clinici Scientifici Maugeri SpA SB Pavia, Italy, 27100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Bologna Policlinico S.Orsola Malpighi Bologna, Italy, 40138 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Health Corporation of Galilee Medical Center Nahariya, Israel, 2210001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Poriya Medical Center | Nephrology and Hypertension Dept. Tiberius, Israel, 1528001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Barzilai Medical Center | Nephrology & Hypertension Dept. Ashkelon, Israel, 7830604 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Corporació Sanitària Parc Taulí Sabadell, Spain, 08208 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Althaia, Xarxa Assistencial de Manresa Manresa, Spain, 08243 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clinico Universitario San Carlos | Nefrologia Madrid, Spain, 28040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital of Athens LAIKO Athens, Greece, 11527 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital of Thessaloniki Papageorgiou Thessaloniki, Greece, 56403 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hippokration General Hospital of Thessaloniki Thessaloniki, Greece, 54642 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Larissa Larissa, Greece, 41110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations HIPPOKRATION General Hospital of Athens Athens, Greece, 115 27 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ioannina University General Hospital Ioannina, Greece, 45500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Krajska Nemocnice Liberec Liberec, Czech Republic, 460 63 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Privamed s.r.o. Plzen, Czech Republic, 323 33 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Nephro Care s.r.o. - Sokolov Sokolov, Czech Republic, 356 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinik Landstraße - Krankenhaus Rudolfstiftung Wien, Austria, 1030 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klinikum Klagenfurt am Wörthersee Klagenfurt, Austria, 9020 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum AKH Wien Wien, Austria, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Privatklinik Wehrle-Diakonissen Salzburg, Austria, 5026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Brovarskaya multidisciplinary clinical hospital Brovary, Ukraine, 07400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyiv City Center of Nephrology and Dialysis Kyiv, Ukraine, 02660 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical center LLC " Fresenius medical care Ukraine» Cherkasy, Ukraine, 18009 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regional Clinical Hospital - Ivano-Frankivsk Ivano-Frankivsk, Ukraine, 76000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations State Institution “Institute of Nephrology” NAMS of Ukraine Kyiv, Ukraine, 04050 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Mykolaiv Regional Clinical Hospital Mykolaiv, Ukraine, 54058 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vinnitsa Regional Clinical Hospital im. N.I. Pirogov Vinnytsia, Ukraine, 21018 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zaporizhzhia Regional Clinical Hospital Zaporizhzhya, Ukraine, 69600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Transcarpatian Regional Clinical Hospital Uzhgorod, Ukraine, 88018 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eurodial Obidos (DaVita) Gaeiras - Obidos, Portugal, 2510-702 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHLO - Hospital Santa Cruz Carnaxide, Portugal, 2795-53 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centro Hospitalar do Medio Tejo | Unidade de Torres Novas - Nephrology Department Torres Novas, Portugal, 2350-754 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Diaverum Aveiro Aveiro, Portugal, 3800-266 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eurodial Leiria (DaVita) Leiria, Portugal, 2400-441 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Van Buren Dialysis Center Riverside, United States, 92503 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations A.O.U. di Parma Parma, Italy, 43126 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations IRCCS Ospedale Policlinico San Martino Genova, Italy, 16132 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AUSL-IRCCS di Reggio Emilia Reggio Emilia, Italy, 42123 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Caledial - Centro de Hemodialise de Gaia Canelas, Portugal, 4410-313 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita South Valley Dialysis Encino, United States, 91316 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations North America Research Institute - Azusa Azusa, United States, 91702 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sverdlovsk Regional Clinical Hospital #1 Yekaterinburg, Russia, 620102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Hospital #31 St. Petersburg, Russia, 197110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Fresenius medical care Kuban Krasnodar, Russia, 350029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC B. Brown Avitum Russland Clinics St. Petersburg, Russia, 193318 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Dialysis center Mytishchi, Russia, 141007 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Dialysis center Kolomna, Russia, 140402 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Yaroslavl dialysis center Yaroslavl, Russia, 150062 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Republican Hospital n.a. V.A. Baranov Petrozavodsk, Russia, 185019 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care Evergreen Park Evergreen Park, United States, 60805 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari Germans Trias i Pujol Badalona, Spain, 08916 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Clalit Health Services Rabin Medical Center-Beilinson Campus Petah Tikva, Israel, 4941492 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shamir Medical Center (Assaf Harofeh) Zerifin, Israel, 7030000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lady Davis Carmel Medical Center Haifa, Israel, 3436212 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kharkiv regional Clinical Centre of urology and nephrology Kharkiv, Ukraine, 61037 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Academisch Medisch Centrum (AMC) AMSTERDAM, Netherlands, 1105 AZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Albert Schweitzer Ziekenhuis, Dordwijk DORDRECHT, Netherlands, 3318 AT | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Butler Farm Dialysis Hampton, United States, 23666 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ARA Holyoke Dialysis Center Holyoke, United States, 01040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations East L.A. Dialysis Center Los Angeles, United States, 90022 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Deventer Ziekenhuis DEVENTER, Netherlands, 7416 SE | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Imeldaziekenhuis - St-Elisabethkliniek Bonheiden, Belgium, 2820 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ Nikolaas Campus Sint-Niklaas SINT-NIKLAAS, Belgium, 9100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Liege | CHR Citadel - Department of Nephrology LIEGE, Belgium, 4000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LUHS Kauno Hospital (Josvainiu str.) Kaunas, Lithuania, LT-47116 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liberty Dialysis- Caldwell Caldwell, United States, 83605 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Queen’s Dialysis Unit West Covina, United States, 91790 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations NephroCare APDP Lisboa, Portugal, 1250-191 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pluribus Dialise - Cascais (DaVita) Cascais, Portugal, 2750-663 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Davita Hospital Hill Dialysis Kansas City, United States, 64108 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care South Dialysis Shreveport, United States, 71106 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Waterloo Dialysis Austin, United States, 78756 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Durham Nephrology Associates, Pa Durham, United States, 27704 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stacja Dializ W-wa Mangalia Warszawa, Poland, 02-758 | 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 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stacja Dializ Olkusz Olkusz, Poland, 32-300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Stacja Dializ Zyrardow Zyrardow, Poland, 96-300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Maasstad Ziekenhuis | Neurology Department Rotterdam, Netherlands, 3079DZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHAT Kanev AD Ruse, Bulgaria, 7002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Sveti Ivan Rilski 2003 Dupnitsa, Bulgaria, 2600 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Haskovo Haskovo, Bulgaria, 6300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Multiprofile Hospital for Active Treatment Hristo Botev AD Vratsa, Bulgaria, 3000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Keszthelyi Korhaz Keszthely, Hungary, 8360 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bajai Szent Rokus Korhaz Baja, Hungary, 6500 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely Hodmezovasarhely, Hungary, 6800 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care Egeszsegugyi Kft. Pecs, Hungary, 7624 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care Egeszsegugyi Kft. Budapest, Hungary, 1083 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saiyu Clinic Koshigaya, Japan, 343-0823 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kikuchi Medical Clinic Tsukuba, Japan, 305-0861 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akagaki Clinic Osaka, Japan, 543-0052 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Saint Hill Hospital Ube, Japan, 755-0155 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Katta General Hospital Shiraishi, Japan, 989-0231 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ohishi Naika Clinic Tsuchiura, Japan, 300-0835 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyoto Station Takeda Dialysis Clinic Kyoto, Japan, 600-8216 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nagaoka Red Cross Hospital Nagaoka, Japan, 940-2085 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ibaraki Seinan Medical Center Hospital Sashima-gun, Japan, 306-0433 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FMC San Ysidro San Diego, United States, 92154 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liberty Dialysis St. George St. George, United States, 84790 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care Baton Rouge Mancuso Lane Baton Rouge, United States, 70808 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care - La Mesa La Mesa, United States, 91942 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ARA Plantation Dialysis, LLC Ellenton, United States, 34222 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care Sugar Land Sugar Land, United States, 77479 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations ARA Augusta Augusta, United States, 30901 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Renal Medicine Associates Albuquerque, United States, 87109 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Greater Waterbury Dialysis Waterbury, United States, 06708 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care Kearny Mesa San Diego, United States, 92111 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius North Austin Dialysis Center Austin, United States, 78758 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care – Mission Bend (FMCNA #3971) Houston, United States, 77083 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yabuki Hospital Yamagata, Japan, 990-0885 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Akebono Clinic Kumamoto, Japan, 861-4112 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care Egeszsegugyi Kft. Miskolc, Hungary, 3526 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations AZ St-Lucas Campus St-Lucas gent, Belgium, 9000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Catharina Ziekenhuis EINDHOVEN, Netherlands, 5623 EJ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Takemura Medical Nephro Clinic Kanuma, Japan, 322-0029 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Futakotamagawaekimae clinic Setagaya-ku, Japan, 158-0094 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tsuchiura Beryl Clinic Tsuchiura, Japan, 300-0062 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Ostrava Ostrava, Czech Republic, 708 52 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lutsk city clinical hospital Lutsk, Ukraine, 43024 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kocaeli Universitesi Tip Fakultesi Kocaeli, Turkey, 41380 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hacettepe Universitesi Tip Fakultesi Ankara, Turkey, 06230 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Turk Bobrek Vakfi Memorial Hizmet Hastanesi Istanbul, Turkey, 34180 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Erciyes Universitesi Tip Fakultesi Kayseri, Turkey, 38039 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Inonu Universitesi Tip Fakultesi Malatya, Turkey, 44280 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Adnan Menderes Universitesi Tip fakultesi Aydin, Turkey, 09100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi Istanbul, Turkey, 34418 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Wojewodzki Szpital Zespolony Kielce, Poland, 25-736 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care - Brawley Brawley, United States, 92227 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kupchinsky center for outpatient dialysis St. Petersburg, Russia, 192102 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chelyabinsk Regional Clinical Hospital Chelyabinsk, Russia, 454076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations City Clinical Hospital #1 Orenburg Orenburg, Russia, 460040 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Dnepropetrovsk regional hospital n.a. I. I. Mechnikov Dnipro, Ukraine, 49005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Pluribus Dialise - Sacavem (DaVita) Sacavem, Portugal, 2685-005 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations John Hunter Hospital New Lambton Heights, Australia, 2305 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eastern Health Integrated Renal Service Box Hill, Australia, 3128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sydney Adventist Hospital Wahroonga, Australia, 2076 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Eszak-Pesti Centrumkorhaz-Honvedkorhaz Budapest, Hungary, 1134 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations General Hospital of Arta Arta, Greece, 47100 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SPD - Amadora (Diaverum Amadora) Amadora, Portugal, 2700-001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Westmead Hospital Westmead, Australia, 2145 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Shumen AD Shumen, Bulgaria, 9700 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Gelre Ziekenhuizen APELDOORN, Netherlands, 7334 DZ | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Rabin Medical Center, HaSharon (Golda) Campus Petach Tikva, Israel, 4937211 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi Poltava, Ukraine, 36011 | 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
- 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.Timeframe: 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.Timeframe: 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).Timeframe: 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.Timeframe: At 6 months (Visit 19 / Day 30 of the 6th month)
Additional Information
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