Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis

PHASE2CompletedINTERVENTIONAL
Enrollment

704

Participants

Timeline

Start Date

August 28, 2020

Primary Completion Date

December 28, 2021

Study Completion Date

May 30, 2022

Conditions
End-stage Renal DiseasePrevention of Thromboembolic EventsHemodialysisHemodiafiltration
Interventions
DRUG

BAY1213790 (Osocimab)

Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.

DRUG

Placebo

Subcutaneous administration in the same manner as Osocimab.

Trial Locations (151)

1030

Klinik Landstraße - Krankenhaus Rudolfstiftung, Vienna

1083

Fresenius Medical Care Egeszsegugyi Kft., Budapest

1090

Universitätsklinikum AKH Wien, Vienna

1134

Eszak-Pesti Centrumkorhaz-Honvedkorhaz, Budapest

2076

Sydney Adventist Hospital, Wahroonga

2145

Westmead Hospital, Westmead

2305

John Hunter Hospital, New Lambton Heights

2600

MHAT Sveti Ivan Rilski 2003, Dupnitsa

2820

Imeldaziekenhuis - St-Elisabethkliniek, Bonheiden

3000

UZ Leuven Gasthuisberg, Leuven

Multiprofile Hospital for Active Treatment Hristo Botev AD, Vratsa

3128

Eastern Health Integrated Renal Service, Box Hill

3526

Fresenius Medical Care Egeszsegugyi Kft., Miskolc

5026

Privatklinik Wehrle-Diakonissen, Salzburg

6300

MHAT Haskovo, Haskovo

6500

Bajai Szent Rokus Korhaz, Baja

6800

Csongrad Megyei Egeszsegugyi Ellato Kozpont,Hodmezovasarhely, Hódmezővásárhely

7002

UMHAT Kanev AD, Rousse

7331

Epicura, Baudour

7624

Fresenius Medical Care Egeszsegugyi Kft., Pécs

8360

Keszthelyi Korhaz, Keszthely

9000

AZ St-Lucas Campus St-Lucas, Ghent

9020

Klinikum Klagenfurt am Wörthersee, Klagenfurt

9100

AZ Nikolaas Campus Sint-Niklaas, Sint-Niklaas

9700

MHAT Shumen AD, Shumen

11527

General Hospital of Athens LAIKO, Athens

15706

Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela

16132

IRCCS Ospedale Policlinico San Martino, Genoa

18009

"Medical center LLC Fresenius medical care Ukraine", Cherkasy

21018

Vinnitsa Regional Clinical Hospital im. N.I. Pirogov, Vinnytsia

23666

DaVita Butler Farm Dialysis, Hampton

27100

IRCCS Istituti Clinici Scientifici Maugeri SpA SB, Pavia

27704

Durham Nephrology Associates, Pa, Durham

30901

ARA Augusta, Augusta

34180

Turk Bobrek Vakfi Memorial Hizmet Hastanesi, Istanbul

34222

ARA Plantation Dialysis, LLC, Ellenton

34418

Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi, Istanbul

36011

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

38039

Erciyes Universitesi Tip Fakultesi, Kayseri

40138

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

41110

University General Hospital of Larissa, Larissa

41380

Kocaeli Universitesi Tip Fakultesi, Kocaeli

42123

AUSL-IRCCS di Reggio Emilia, Reggio Emilia

43024

Lutsk city clinical hospital, Lutsk

43126

A.O.U. di Parma, Parma

44280

Inonu Universitesi Tip Fakultesi, Malatya

45500

Ioannina University General Hospital, Ioannina

46010

Hospital Clínico Universitario de Valencia, Valencia

46017

Hospital Universitario Dr. Peset, Valencia

47100

General Hospital of Arta, Arta

49005

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

50134

A.O.U. Careggi, Florence

54058

Mykolaiv Regional Clinical Hospital, Mykolaiv

54642

Hippokration General Hospital of Thessaloniki, Thessaloniki

56403

General Hospital of Thessaloniki Papageorgiou, Thessaloniki

60805

Fresenius Kidney Care Evergreen Park, Evergreen Park

61037

Kharkiv regional Clinical Centre of urology and nephrology, Kharkiv

64108

Davita Hospital Hill Dialysis, Kansas City

69600

Zaporizhzhia Regional Clinical Hospital, Zaporizhzhya

70808

Fresenius Kidney Care Baton Rouge Mancuso Lane, Baton Rouge

71106

Fresenius Kidney Care South Dialysis, Shreveport

76000

Regional Clinical Hospital - Ivano-Frankivsk, Ivano-Frankivsk

77083

Fresenius Kidney Care - Mission Bend (FMCNA #3971), Houston

77479

Fresenius Kidney Care Sugar Land, Sugar Land

78756

Waterloo Dialysis, Austin

78758

Fresenius North Austin Dialysis Center, Austin

83605

Liberty Dialysis- Caldwell, Caldwell

84790

Liberty Dialysis St. George, St. George

87109

Renal Medicine Associates, Albuquerque

88018

Transcarpatian Regional Clinical Hospital, Uzhhorod

90022

East L.A. Dialysis Center, Los Angeles

91316

DaVita South Valley Dialysis, Encino

91702

North America Research Institute - Azusa, Azusa

91790

Queen's Dialysis Unit, West Covina

91942

Fresenius Kidney Care - La Mesa, La Mesa

92111

Fresenius Kidney Care Kearny Mesa, San Diego

92154

FMC San Ysidro, San Diego

92227

Fresenius Kidney Care - Brawley, Brawley

92503

Van Buren Dialysis Center, Riverside

140402

LLC Dialysis center, Kolomna

141007

LLC Dialysis center, Mytishchi

150062

LLC Yaroslavl dialysis center, Yaroslavl

185019

Republican Hospital n.a. V.A. Baranov, Petrozavodsk

192102

Kupchinsky center for outpatient dialysis, Saint Petersburg

193318

LLC B. Brown Avitum Russland Clinics, Saint Petersburg

197110

City Hospital #31, Saint Petersburg

350029

LLC Fresenius medical care Kuban, Krasnodar

454076

Chelyabinsk Regional Clinical Hospital, Chelyabinsk

460040

City Clinical Hospital #1 Orenburg, Orenburg

620102

Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

2210001

Health Corporation of Galilee Medical Center, Nahariya

3436212

Lady Davis Carmel Medical Center, Haifa

4937211

Rabin Medical Center, HaSharon (Golda) Campus, Petah Tikva

4941492

Clalit Health Services Rabin Medical Center-Beilinson Campus, Petah Tikva

7030000

Shamir Medical Center (Assaf Harofeh), Ẕerifin

06708

DaVita Greater Waterbury Dialysis, Waterbury

01040

ARA Holyoke Dialysis Center, Holyoke

Unknown

"CHU de Liege , CHR Citadel - Department of Nephrology"

"Barzilai Medical Center , Nephrology & Hypertension Dept."

"Poriya Medical Center , Nephrology and Hypertension Dept."

"Maasstad Ziekenhuis , Neurology Department"

"Hospital Clinico Universitario San Carlos , Nefrologia"

460 63

Krajska Nemocnice Liberec, Liberec

708 52

Fakultni nemocnice Ostrava, Ostrava

323 33

Privamed s.r.o., Pilsen

356 01

Fresenius Nephro Care s.r.o. - Sokolov, Sokolov

115 27

HIPPOKRATION General Hospital of Athens, Athens

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome

306-0433

Ibaraki Seinan Medical Center Hospital, Sashima-gun

300-0062

Tsuchiura Beryl Clinic, Tsuchiura

300-0835

Ohishi Naika Clinic, Tsuchiura

305-0861

Kikuchi Medical Clinic, Tsukuba

989-0231

Katta General Hospital, Shiraishi

940-2085

Nagaoka Red Cross Hospital, Nagaoka

343-0823

Saiyu Clinic, Koshigaya

322-0029

Takemura Medical Nephro Clinic, Kanuma

158-0094

Futakotamagawaekimae clinic, Setagaya-ku

755-0155

Saint Hill Hospital, Ube

861-4112

Akebono Clinic, Kumamoto

600-8216

Kyoto Station Takeda Dialysis Clinic, Kyoto

543-0052

Akagaki Clinic, Osaka

990-0885

Yabuki Hospital, Yamagata

LT-47116

LUHS Kauno Hospital (Josvainiu str.), Kaunas

1105 AZ

Academisch Medisch Centrum (AMC), Amsterdam

7334 DZ

Gelre Ziekenhuizen, Apeldoorn

7416 SE

Deventer Ziekenhuis, Deventer

3318 AT

Albert Schweitzer Ziekenhuis, Dordwijk, Dordrecht

5623 EJ

Catharina Ziekenhuis, Eindhoven

86-100

NZOZ Nowy Szpital w Swieciu Sp. z o.o., Gmina Świecie

25-736

Wojewodzki Szpital Zespolony, Kielce

32-300

Stacja Dializ Olkusz, Olkusz

02-758

Stacja Dializ W-wa Mangalia, Warsaw

96-300

Stacja Dializ Zyrardow, Żyrardów

2510-702

Eurodial Obidos (DaVita), Gaeiras - Obidos

2700-001

SPD - Amadora (Diaverum Amadora), Amadora

2795-53

CHLO - Hospital Santa Cruz, Carnaxide

2750-663

Pluribus Dialise - Cascais (DaVita), Cascais

2685-005

Pluribus Dialise - Sacavem (DaVita), Sacavém

4410-313

Caledial - Centro de Hemodialise de Gaia, Canelas

Santarém District

"Centro Hospitalar do Medio Tejo , Unidade de Torres Novas - Nephrology Department"

3800-266

Diaverum Aveiro, Aveiro

2400-441

Eurodial Leiria (DaVita), Leiria

1250-191

NephroCare APDP, Lisbon

08916

Hospital Universitari Germans Trias i Pujol, Badalona

08243

Hospital Althaia, Xarxa Assistencial de Manresa, Manresa

08208

Corporació Sanitària Parc Taulí, Sabadell

06230

Hacettepe Universitesi Tip Fakultesi, Ankara

09100

Adnan Menderes Universitesi Tip fakultesi, Aydin

07400

Brovarskaya multidisciplinary clinical hospital, Brovary

02660

Kyiv City Center of Nephrology and Dialysis, Kyiv

04050

"State Institution Institute of Nephrology NAMS of Ukraine", Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY