Factor XI LICA to Reduce Events Such as Heart Attack and Stroke in Patients Whose Kidneys Are no Longer Able to Work as They Should and Require Treatment to Filter Wastes From the Blood: Focus is on the Safety of BAY2976217 and the Way the Body Absorbs, Distributes and Removes the Study Drug

PHASE2CompletedINTERVENTIONAL
Enrollment

307

Participants

Timeline

Start Date

September 4, 2020

Primary Completion Date

January 24, 2022

Study Completion Date

May 12, 2022

Conditions
End Stage Renal Disease Requiring Hemodialysis
Interventions
DRUG

Fesomersen sodium (BAY2976217)

Study intervention will be injected subcutaneously.

DRUG

Placebo

Matching placebo to BAY2976217 will be injected subcutaneously.

Trial Locations (69)

110

Taipei Medical University Hospital, Taipei

710

Chi Mei Medical Center, Tainan City

1090

UZ Brussel, Bruxelles - Brussel

1233

"MHAT Knyaginya Klementina - SofiaEAD", Sofia

1309

MHAT National Cardiology Hospital EAD, Sofia

2000

MHAT Samokov, Samokov

2650

UZ Antwerpen, Edegem

3400

First Dialysis Services Bulgaria Ead, Montana

6300

Bacs-Kiskun Megyei Korhaz, Kalocsa

6720

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont, Szeged

8036

Hospital Clínic i Provincial de Barcelona, Barcelona

8900

Regionaal ZH Jan Yperman Campus Mariaziekenhuis, Ieper

9300

OL Vrouwziekenhuis - Campus Aalst, Aalst

14034

Medical Center Fresenius Medical Care Ukraine, LLC, Chernihiv

21431

The Catholic University of Korea, Incheon St.Mary's Hospital, Incheon

24105

Universitätsklinikum Schleswig-Holstein (UKSH), Kiel

24153

Salem VA Medical Center, Salem

26504

University General Hospital of Patra, Pátrai

28805

Hospital Principe de Asturias, Alcalá de Henares

33316

Davita East Ft. Lauderdale Dialysis Center, Fort Lauderdale

40210

DaVita Clinical Research Deutschland GmbH, Düsseldorf

46002

Ternopil Regional Clinical Hospital, Ternopil

52511

DaVita Clinical Resarch Germany GmbH, Geilenkirchen

57010

PAPANIKOLAOU General Hospital Thessaloniki, Pilea Chortiatis

63074

Fresenius Kidney Care St. Louis Regional Dialysis, Saint Ann

63110

Chromalloy Dialysis Center, St Louis

65025

Regional Clinical Hospital - Odessa, Odesa

69001

Zaporizhia Municipal Clinical Hospital No.10, Zaporizhzhya

78229

DaVita Northwest Medical Center Dialysis, San Antonio

78258

San Antonio Kidney Disease Center Physicians Group, PLLC, San Antonio

89128

Fresenius Medical Care - Fire Mesa Dialysis Unit, Las Vegas

92392

Desert Cities Dialysis-Amethyst & Desert Cities Dialysis, Victorville

93611

Fresenius Kidney Care Clovis, Clovis

125466

High Technology Center Clinic 1, Moscow

142110

LLC Dialysis center, Podolsk

195067

Botkin clinical infectious diseases hospital, Saint Petersburg

196247

LLC B. Brown Avitum Russland Clinics, Saint Petersburg

State Budgetary Healthcare Institution City Hospital #26, Saint Petersburg

197374

Nikiforov All-Russian Center of Emergency and Radiation Med, Saint Petersburg

440034

LLC Frezenius Nefrocare, Penza

630064

"Limited Liability Company Nefroline-Novosibirsk", Novosibirsk

M9V 1R8

Etobicoke General Hospital, Etobicoke

L8N 4A6

St. Joseph's Healthcare - Hamilton, Hamilton

L1G 2B9

Lakeridge Health-Oshawa, Oshawa

M5B 1W8

Unity Health Toronto: St. Michael's Hospital, Toronto

H2T 3B3

Centre de services ambulatoires de dialyse de Gaspé, Montreal

G1J 1Z4

CHU de Québec-Université Laval, Québec

738 01

Nemocnice Frydek-Mistek, Frýdek-Místek

339 01

Klatovska nemocnice, Klatovy

276 01

Fresenius Medical Care - DS, s.r.o., Mělník

293 50

Oblastni nemocnice Mlada Boleslav, Mladá Boleslav

711 10

University General Hospital of Heraklion, Heraklion

501-6062

Matsunami General Hospital, Hashima-gun

004-0041

Sapporo Tokushukai Hospital, Sapporo

309-1793

Ibaraki Prefectural Central Hospital, Kasama

924-8588

Public Central Hospital of Matto Ishikawa, Hakusan

251-0041

Shonan Fujisawa Tokushukai Hospital, Fujisawa

348-0045

Hanyu General Hospital, Hanyū

263-0043

Medical corporation association Shunshin-kai Inage hospital, Chiba

LV-5417

Daugavpils Regional Hospital, Daugavpils

LV-3414

Liepaja Regional Hospital, Liepāja

LV-1002

P. Stradins Clinical University Hospital, Riga

LV-4201

Vidzemes Hospital, Valmiera

150-713

Yeouido St. Mary's Hospital, Seoul

Unknown

"Hospital Universitari de Bellvitge , Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention"

"Hospital Universitario Virgen de las Nieves, Nefrologia"

"Hospital Universitari i Politècnic La Fe , Nefrología"

01023

Kyiv City Center of Nephrology and Dialysis, Kyiv

04107

Kyiv Regional Clinical Hospital, Kyiv

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY