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:

NCT04523220

EudraCT Number:

2019-003957-27

Study Completed

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
686
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
Yes
Products
Osocimab (BAY1213790)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Epicura

Baudour, Belgium, 7331

Status
Completed
 
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
 
Locations

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
Completed
 
Locations

Hospital Universitario Dr. Peset

Valencia, Spain, 46017

Status
Completed
 
Locations

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Status
Completed
 
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Completed
 
Locations

IRCCS Istituti Clinici Scientifici Maugeri SpA SB

Pavia, Italy, 27100

Status
Completed
 
Locations

A.O.U. di Bologna Policlinico S.Orsola Malpighi

Bologna, Italy, 40138

Status
Completed
 
Locations

Health Corporation of Galilee Medical Center

Nahariya, Israel, 2210001

Status
Completed
 
Locations

Poriya Medical Center | Nephrology and Hypertension Dept.

Tiberius, Israel, 1528001

Status
Completed
 
Locations

Barzilai Medical Center | Nephrology & Hypertension Dept.

Ashkelon, Israel, 7830604

Status
Completed
 
Locations

Corporació Sanitària Parc Taulí

Sabadell, Spain, 08208

Status
Completed
 
Locations

Hospital Althaia, Xarxa Assistencial de Manresa

Manresa, Spain, 08243

Status
Completed
 
Locations

Hospital Clinico Universitario San Carlos | Nefrologia

Madrid, Spain, 28040

Status
Completed
 
Locations

General Hospital of Athens LAIKO

Athens, Greece, 11527

Status
Completed
 
Locations

General Hospital of Thessaloniki Papageorgiou

Thessaloniki, Greece, 56403

Status
Completed
 
Locations

Hippokration General Hospital of Thessaloniki

Thessaloniki, Greece, 54642

Status
Completed
 
Locations

University General Hospital of Larissa

Larissa, Greece, 41110

Status
Completed
 
Locations

HIPPOKRATION General Hospital of Athens

Athens, Greece, 115 27

Status
Completed
 
Locations

Ioannina University General Hospital

Ioannina, Greece, 45500

Status
Completed
 
Locations

Krajska Nemocnice Liberec a.s.

Liberec, Czech Republic, 460 63

Status
Completed
 
Locations

Privamed s.r.o.

Plzen, Czech Republic, 323 33

Status
Completed
 
Locations

Fresenius Nephro Care s.r.o. - Sokolov

Sokolov, Czech Republic, 356 01

Status
Completed
 
Locations

Klinik Landstraße - Krankenhaus Rudolfstiftung

Wien, Austria, 1030

Status
Completed
 
Locations

Klinikum Klagenfurt am Wörthersee

Klagenfurt, Austria, 9020

Status
Completed
 
Locations

Universitätsklinikum AKH Wien

Wien, Austria, 1090

Status
Completed
 
Locations

Privatklinik Wehrle-Diakonissen

Salzburg, Austria, 5026

Status
Completed
 
Locations

Brovarskaya multidisciplinary clinical hospital

Brovary, Ukraine, 07400

Status
Completed
 
Locations

Kyiv City Center of Nephrology and Dialysis

Kyiv, Ukraine, 02660

Status
Completed
 
Locations

Medical center LLC " Fresenius medical care Ukraine»

Cherkasy, Ukraine, 18009

Status
Completed
 
Locations

Regional Clinical Hospital - Ivano-Frankivsk

Ivano-Frankivsk, Ukraine, 76000

Status
Completed
 
Locations

State Institution “Institute of Nephrology” NAMS of Ukraine

Kyiv, Ukraine, 04050

Status
Completed
 
Locations

Mykolaiv Regional Clinical Hospital

Mykolaiv, Ukraine, 54058

Status
Completed
 
Locations

Vinnitsa Regional Clinical Hospital im. N.I. Pirogov

Vinnytsia, Ukraine, 21018

Status
Completed
 
Locations

Zaporizhzhia Regional Clinical Hospital

Zaporizhzhya, Ukraine, 69600

Status
Completed
 
Locations

Transcarpatian Regional Clinical Hospital

Uzhgorod, Ukraine, 88018

Status
Completed
 
Locations

Eurodial Obidos (DaVita)

Gaeiras - Obidos, Portugal, 2510-702

Status
Completed
 
Locations

CHLO - Hospital Santa Cruz

Carnaxide, Portugal, 2795-53

Status
Completed
 
Locations

CHMT - Hospital Rainha Santa Isabel - Servico de Nefrologia

Torres Novas, Portugal, 2350-754

Status
Completed
 
Locations

Diaverum Aveiro

Aveiro, Portugal, 3800-266

Status
Completed
 
Locations

Eurodial Leiria (DaVita)

Leiria, Portugal, 2400-441

Status
Completed
 
Locations

Van Buren Dialysis Center

Riverside, United States, 92503

Status
Completed
 
Locations

A.O.U. di Parma

Parma, Italy, 43126

Status
Completed
 
Locations

IRCCS Ospedale Policlinico San Martino

Genova, Italy, 16132

Status
Completed
 
Locations

AUSL-IRCCS di Reggio Emilia

Reggio Emilia, Italy, 42123

Status
Completed
 
Locations

Caledial - Centro de Hemodialise de Gaia

Canelas, Portugal, 4410-313

Status
Completed
 
Locations

DaVita South Valley Dialysis

Encino, United States, 91316

Status
Completed
 
Locations

North America Research Institute - Azusa

Azusa, United States, 91702

Status
Completed
 
Locations

Sverdlovsk Regional Clinical Hospital #1

Yekaterinburg, Russia, 620102

Status
Completed
 
Locations

City Hospital #31

St. Petersburg, Russia, 197110

Status
Completed
 
Locations

LLC Fresenius medical care Kuban

Krasnodar, Russia, 350029

Status
Completed
 
Locations

LLC B. Brown Avitum Russland Clinics

St. Petersburg, Russia, 193318

Status
Completed
 
Locations

LLC Dialysis center

Mytishchi, Russia, 141007

Status
Completed
 
Locations

LLC Dialysis center

Kolomna, Russia, 140402

Status
Completed
 
Locations

LLC Yaroslavl dialysis center

Yaroslavl, Russia, 150062

Status
Completed
 
Locations

Republican Hospital n.a. V.A. Baranov

Petrozavodsk, Russia, 185019

Status
Completed
 
Locations

Fresenius Kidney Care Evergreen Park

Evergreen Park, United States, 60805

Status
Completed
 
Locations

Hospital Universitari Germans Trias i Pujol

Badalona, Spain, 08916

Status
Completed
 
Locations

Clalit Health Services Rabin Medical Center-Beilinson Campus

Petah Tikva, Israel, 4941492

Status
Completed
 
Locations

Shamir Medical Center (Assaf Harofeh)

Zerifin, Israel, 7030000

Status
Completed
 
Locations

Lady Davis Carmel Medical Center

Haifa, Israel, 3436212

Status
Completed
 
Locations

Kharkiv regional Clinical Centre of urology and nephrology

Kharkiv, Ukraine, 61037

Status
Completed
 
Locations

Academisch Medisch Centrum (AMC)

AMSTERDAM, Netherlands, 1105 AZ

Status
Completed
 
Locations

Albert Schweitzer Ziekenhuis, Locatie Dordwijk

DORDRECHT, Netherlands, 3318 AT

Status
Completed
 
Locations

DaVita Butler Farm Dialysis

Hampton, United States, 23666

Status
Completed
 
Locations

ARA Holyoke Dialysis Center

Holyoke, United States, 01040

Status
Completed
 
Locations

East L.A. Dialysis Center

Los Angeles, United States, 90022

Status
Completed
 
Locations

Deventer Ziekenhuis

DEVENTER, Netherlands, 7416 SE

Status
Completed
 
Locations

Imeldaziekenhuis - St-Elisabethkliniek

BONHEIDEN, Belgium, 2820

Status
Completed
 
Locations

AZ Nikolaas Campus Sint-Niklaas

SINT-NIKLAAS, Belgium, 9100

Status
Completed
 
Locations

CHU de Liege | CHR Citadel - Department of Nephrology

LIEGE, Belgium, 4000

Status
Completed
 
Locations

LUHS Kauno Hospital (Josvainiu str.)

Kaunas, Lithuania, LT-47116

Status
Completed
 
Locations

Liberty Dialysis- Caldwell

Caldwell, United States, 83605

Status
Completed
 
Locations

Queen’s Dialysis Unit

West Covina, United States, 91790

Status
Completed
 
Locations

NephroCare APDP

Lisboa, Portugal, 1250-191

Status
Completed
 
Locations

Pluribus Dialise - Cascais (DaVita)

Cascais, Portugal, 2750-663

Status
Completed
 
Locations

Davita Hospital Hill Dialysis

Kansas City, United States, 64108

Status
Completed
 
Locations

Fresenius Kidney Care South Dialysis

Shreveport, United States, 71106

Status
Completed
 
Locations

Waterloo Dialysis

Austin, United States, 78756

Status
Completed
 
Locations

Durham Nephrology Associates, Pa

Durham, United States, 27704

Status
Completed
 
Locations

Stacja Dializ W-wa Mangalia

Warszawa, Poland, 02-758

Status
Completed
 
Locations

NZOZ Nowy Szpital w Swieciu Sp. z o.o.

Swiecie, Poland, 86-100

Status
Completed
 
Locations

Stacja Dializ Olkusz

Olkusz, Poland, 32-300

Status
Completed
 
Locations

Stacja Dializ Zyrardow

Zyrardow, Poland, 96-300

Status
Completed
 
Locations

Maasstad Ziekenhuis

ROTTERDAM, Netherlands, 3079 DZ

Status
Completed
 
Locations

UMHAT Kanev AD

Ruse, Bulgaria, 7002

Status
Completed
 
Locations

MHAT Sveti Ivan Rilski 2003

Dupnitsa, Bulgaria, 2600

Status
Completed
 
Locations

MHAT Haskovo

Haskovo, Bulgaria, 6300

Status
Completed
 
Locations

Multiprofile Hospital for Active Treatment Hristo Botev AD

Vratsa, Bulgaria, 3000

Status
Completed
 
Locations

Keszthelyi Korhaz

Keszthely, Hungary, 8360

Status
Completed
 
Locations

Bajai Szent Rokus Korhaz

Baja, Hungary, 6500

Status
Completed
 
Locations

Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely

Hodmezovasarhely, Hungary, 6800

Status
Completed
 
Locations

Fresenius Medical Care Egeszsegugyi Kft.

Pecs, Hungary, 7624

Status
Completed
 
Locations

Fresenius Medical Care Egeszsegugyi Kft.

Budapest, Hungary, 1083

Status
Completed
 
Locations

Saiyu Clinic

Koshigaya, Japan, 343-0823

Status
Completed
 
Locations

Kikuchi Medical Clinic

Tsukuba, Japan, 305-0861

Status
Completed
 
Locations

Akagaki Clinic

Osaka, Japan, 543-0052

Status
Completed
 
Locations

Saint Hill Hospital

Ube, Japan, 755-0155

Status
Completed
 
Locations

Katta General Hospital

Shiraishi, Japan, 989-0231

Status
Completed
 
Locations

Ohishi Naika Clinic

Tsuchiura, Japan, 300-0835

Status
Completed
 
Locations

Kyoto Station Takeda Dialysis Clinic

Kyoto, Japan, 600-8216

Status
Completed
 
Locations

Nagaoka Red Cross Hospital

Nagaoka, Japan, 940-2085

Status
Completed
 
Locations

Ibaraki Seinan Medical Center Hospital

Sashima-gun, Japan, 306-0433

Status
Completed
 
Locations

FMC San Ysidro

San Diego, United States, 92154

Status
Completed
 
Locations

Liberty Dialysis St. George

St. George, United States, 84790

Status
Completed
 
Locations

Fresenius Kidney Care Baton Rouge Mancuso Lane

Baton Rouge, United States, 70808

Status
Completed
 
Locations

Fresenius Kidney Care - La Mesa

La Mesa, United States, 91942

Status
Completed
 
Locations

ARA Plantation Dialysis, LLC

Ellenton, United States, 34222

Status
Completed
 
Locations

Fresenius Kidney Care Sugar Land

Sugar Land, United States, 77479

Status
Completed
 
Locations

ARA Augusta

Augusta, United States, 30901

Status
Completed
 
Locations

Renal Medicine Associates

Albuquerque, United States, 87109

Status
Completed
 
Locations

DaVita Greater Waterbury Dialysis

Waterbury, United States, 06708

Status
Completed
 
Locations

Fresenius Kidney Care Kearny Mesa

San Diego, United States, 92111

Status
Completed
 
Locations

Fresenius North Austin Dialysis Center

Austin, United States, 78758

Status
Completed
 
Locations

Fresenius Kidney Care – Mission Bend (FMCNA #3971)

Houston, United States, 77083

Status
Completed
 
Locations

Yabuki Hospital

Yamagata, Japan, 990-0885

Status
Completed
 
Locations

Akebono Clinic

Kumamoto, Japan, 861-4112

Status
Completed
 
Locations

Fresenius Medical Care Egeszsegugyi Kft.

Miskolc, Hungary, 3526

Status
Completed
 
Locations

AZ St-Lucas Campus St-Lucas

GENT, Belgium, 9000

Status
Completed
 
Locations

Catharina Ziekenhuis

EINDHOVEN, Netherlands, 5623 EJ

Status
Completed
 
Locations

Takemura Medical Nephro Clinic

Kanuma, Japan, 322-0029

Status
Completed
 
Locations

Futakotamagawaekimae clinic

Setagaya-ku, Japan, 158-0094

Status
Completed
 
Locations

Tsuchiura Beryl Clinic

Tsuchiura, Japan, 300-0062

Status
Completed
 
Locations

Fakultni nemocnice Ostrava

Ostrava, Czech Republic, 708 52

Status
Completed
 
Locations

Lutsk city clinical hospital

Lutsk, Ukraine, 43024

Status
Completed
 
Locations

Kocaeli Universitesi Tip Fakultesi

Kocaeli, Turkey, 41380

Status
Completed
 
Locations

Hacettepe Universitesi Tip Fakultesi

Ankara, Turkey, 06230

Status
Completed
 
Locations

Turk Bobrek Vakfi Memorial Hizmet Hastanesi

Istanbul, Turkey, 34180

Status
Completed
 
Locations

Erciyes Universitesi Tip Fakultesi

Kayseri, Turkey, 38039

Status
Completed
 
Locations

Inonu Universitesi Tip Fakultesi

Malatya, Turkey, 44280

Status
Completed
 
Locations

Adnan Menderes Universitesi Tip fakultesi

Aydin, Turkey, 09100

Status
Completed
 
Locations

Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi

Istanbul, Turkey, 34418

Status
Completed
 
Locations

Wojewodzki Szpital Zespolony

Kielce, Poland, 25-736

Status
Completed
 
Locations

Fresenius Kidney Care - Brawley

Brawley, United States, 92227

Status
Completed
 
Locations

Kupchinsky center for outpatient dialysis

St. Petersburg, Russia, 192102

Status
Completed
 
Locations

Chelyabinsk Regional Clinical Hospital

Chelyabinsk, Russia, 454076

Status
Completed
 
Locations

City Clinical Hospital #1 Orenburg

Orenburg, Russia, 460040

Status
Completed
 
Locations

Dnepropetrovsk regional hospital n.a. I. I. Mechnikov

Dnipro, Ukraine, 49005

Status
Completed
 
Locations

Pluribus Dialise - Sacavem (DaVita)

Sacavem, Portugal, 2685-005

Status
Completed
 
Locations

John Hunter Hospital

New Lambton Heights, Australia, 2305

Status
Completed
 
Locations

Eastern Health Integrated Renal Service

Box Hill, Australia, 3128

Status
Completed
 
Locations

Sydney Adventist Hospital

Wahroonga, Australia, 2076

Status
Completed
 
Locations

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary, 1134

Status
Completed
 
Locations

General Hospital of Arta

Arta, Greece, 47100

Status
Completed
 
Locations

SPD - Amadora (Diaverum Amadora)

Amadora, Portugal, 2700-001

Status
Completed
 
Locations

Westmead Hospital

Westmead, Australia, 2145

Status
Completed
 
Locations

MHAT Shumen AD

Shumen, Bulgaria, 9700

Status
Completed
 
Locations

Gelre Ziekenhuizen

APELDOORN, Netherlands, 7334 DZ

Status
Completed
 
Locations

Rabin Medical Center, HaSharon (Golda) Campus

Petach Tikva, Israel, 4937211

Status
Completed
 
Locations

Poltava Regional Clinical Hospital n.a. M.V. Skliphosovskyi

Poltava, Ukraine, 36011

Status
Completed
 

Trial Design