Trial Condition(s):

End stage renal disease requiring hemodialysis

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 (RE-THINc ESRD)

Bayer Identifier:

21170

ClinicalTrials.gov Identifier:

NCT04534114

EudraCT Number:

2019-003927-39

Study Completed

Trial Purpose

Patients whose kidneys are no longer able to work as they should and require treatment to filter wastes from the blood (hemodialysis) are at high risk for blood clots that form in blood vessels (thrombosis) blocking blood flow that causes heart attacks, strokes, and other life-threatening conditions. BAY2976217 is under clinical development for prevention of thrombosis. The goal of the study is to learn more about the safety of BAY2976217, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as multiple doses in participants with renal impairment who require hemodialysis.

Inclusion Criteria
- Participant must be at least 18 years of age at the time of signing the informed consent form (ICF)
- Participants with ESRD on hemodialysis (HD) for ≥3 months at the time of signing of the ICF, receiving dialysis at least 9 hours a week and stable in the view of the investigator
- Male 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)
- Capable of giving signed ICF as described in the Protocol, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol
Exclusion Criteria
- Participants receiving antiplatelet therapy except daily acetylsalicylic acid (ASA) ≤ 150 mg/day
- Participants receiving anticoagulation in therapeutic doses, other than standard anticoagulation during the hemodialysis procedure
- Known inherited bleeding disorder e.g. von-Willebrand disease or Hemophilia A, B or C
- Recent (<6 months before screening) clinically significant bleeding, or at high risk of bleeding (in the judgement of the investigator)
- Recent (<3 months before screening) thromboembolic event, e.g. acute coronary syndrome, stroke, or Venous thromboembolism (except dialysis access thrombosis)
- Recent (<3 months before screening) major surgery or scheduled major surgery during participation in the study
- Scheduled living donor renal transplant during study participation
- Known Hepatitis B or C
- Known HIV with recent documented detectable viral load (<3 months
before screening)
- Persistent heart failure as classified by the New York Heart Association classification of 3 or higher
- Life expectancy less than 6 months
- Sustained uncontrolled hypertension (persistent measurements of diastolic blood pressure ≥ 100 mmHg, and/or systolic blood pressure ≥ 180 mmHg)
- Hepatic disease associated with either: coagulopathy leading to a clinically relevant bleeding risk, or ALT > 3x ULN, or total bilirubin >2x ULN with direct bilirubin > 20% of the total
- Hb < 9.0 g/dL at screening
- Platelet count < 120,000 mm3 at screening
- Known hypersensitivity to the investigational drug or to inactive constituents of the study intervention
- Active malignancy requiring treatment during study participation (except non-melanoma skin cancer, or cervical carcinoma in situ)
- Participation in a study with an investigational medicinal product within 30 days or within 5 half-lives of the previous administered drug, whichever is longer, prior to the screening/observational period (Note: Participants from previous BAY 2306001/ISIS 416858 and BAY 2976217/ ION 957943 studies are eligible)
- Any other conditions, which, in the opinion of the investigator or Sponsor would make the subject unsuitable for inclusion
- Confirmed pregnancy

Trial Summary

Enrollment Goal
307
Trial Dates
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Phase
2
Could I receive a placebo?
Yes
Products
Fesomersen (BAY2976217)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Robert-Bosch-Krankenhaus

Stuttgart, Germany, 70376

Status
Terminated
 
Locations

Nephrologisches Zentrum Hoyerswerda

Hoyerswerda, Germany, 02977

Status
Terminated
 
Locations

DaVita Clinical Research Deutschland GmbH

Düsseldorf, Germany, 40210

Status
Completed
 
Locations

Universitätsklinikum Schleswig-Holstein (UKSH)

Kiel, Germany, 24105

Status
Completed
 
Locations

DaVita Northwest Medical Center Dialysis

San Antonio, United States, 78229

Status
Completed
 
Locations

Fresenius Medical Care - Fire Mesa Dialysis Unit

Las Vegas, United States, 89128

Status
Completed
 
Locations

San Antonio Kidney Disease Center Physicians Group, PLLC

San Antonio, United States, 78258

Status
Completed
 
Locations

Chromalloy Dialysis Center

St. Louis, United States, 63110

Status
Completed
 
Locations

Desert Cities Dialysis-Amethyst & Desert Cities Dialysis

Victorville, United States, 92392

Status
Completed
 
Locations

Fresenius Kidney Care Clovis

Clovis, United States, 93611

Status
Completed
 
Locations

Fresenius Kidney Care St. Louis Regional Dialysis

St. Ann, United States, 63074

Status
Completed
 
Locations

Davita East Ft. Lauderdale Dialysis Center

Ft. Lauderdale, United States, 33316

Status
Completed
 
Locations

Hospital Universitario Virgen de las Nieves|Nefrologia

Granada, Spain, 18014

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

Ciutat Sanitària i Universitària de Bellvitge

L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Hospital Principe de Asturias

Alcalá de Henares, Spain, 28805

Status
Completed
 
Locations

Lakeridge Health-Oshawa

Oshawa, Canada, L1G 2B9

Status
Completed
 
Locations

Etobicoke General Hospital

Etobicoke, Canada, M9V 1R8

Status
Completed
 
Locations

St. Joseph's Healthcare - Hamilton

Hamilton, Canada, L8N 4A6

Status
Completed
 
Locations

St. Michael's Hospital

Toronto, Canada, M5B 1W8

Status
Completed
 
Locations

CHU de Québec-Université Laval

Quebec, Canada, G1R 2J6

Status
Completed
 
Locations

Centre de services ambulatoires de dialyse de Gaspé

Montreal, Canada, H2T 3B3

Status
Completed
 
Locations

Regionaal ZH Jan Yperman Campus Mariaziekenhuis

IEPER, Belgium, 8900

Status
Completed
 
Locations

UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

UZ Brussel

BRUXELLES - BRUSSEL, Belgium, 1090

Status
Completed
 
Locations

OL Vrouwziekenhuis - Campus Aalst

AALST, Belgium, 9300

Status
Completed
 
Locations

Oblastni nemocnice Mlada Boleslav

Mlada Boleslav, Czech Republic, 293 50

Status
Completed
 
Locations

Nemocnice Frydek-Mistek

Frydek-Mistek, Czech Republic, 738 01

Status
Completed
 
Locations

Klatovska nemocnice

Klatovy, Czech Republic, 339 01

Status
Completed
 
Locations

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

Melnik, Czech Republic, 276 01

Status
Completed
 
Locations

MHAT "Knyaginya Klementina - Sofia"EAD

Sofia, Bulgaria, 1233

Status
Completed
 
Locations

MHAT National Cardiology Hospital EAD

Sofia, Bulgaria, 1309

Status
Completed
 
Locations

FIRST DIALYSIS SERVICES BULGARIA EAD

Montana, Bulgaria, 3400

Status
Completed
 
Locations

MHAT Samokov

Samokov, Bulgaria, 2000

Status
Completed
 
Locations

University General Hospital of Patra

Patra, Greece, 26504

Status
Completed
 
Locations

PAPANIKOLAOU General Hospital Thessaloniki

Pilea Chortiatis, Greece, 57010

Status
Completed
 
Locations

University General Hospital of Heraklion

Heraklion, Greece, 711 10

Status
Completed
 
Locations

Limited Liability Company "Nefroline-Novosibirsk"

Novosibirsk, Russia, 630064

Status
Completed
 
Locations

LLC Dialysis center

Podolsk, Russia, 142110

Status
Completed
 
Locations

High Technology Center Clinic 1

Moscow, Russia, 125466

Status
Completed
 
Locations

LLC Frezenius Nefrocare

Penza, Russia, 440034

Status
Completed
 
Locations

Kyiv City Center of Nephrology and Dialysis

Kyiv, Ukraine, 01023

Status
Completed
 
Locations

Zaporizhia Municipal Clinical Hospital No.10

Zaporizhzhya, Ukraine, 69001

Status
Completed
 
Locations

Regional Clinical Hospital - Odessa

Odesa, Ukraine, 65025

Status
Completed
 
Locations

Medical Center Fresenius Medical Care Ukraine, LLC

Chernigiv, Ukraine, 14034

Status
Completed
 
Locations

P. Stradins Clinical University Hospital

Riga, Latvia, LV-1002

Status
Completed
 
Locations

Vidzemes Hospital

Valmiera, Latvia, LV-4201

Status
Completed
 
Locations

Liepaja Regional Hospital

Liepaja, Latvia, LV-3414

Status
Completed
 
Locations

Daugavpils Regional Hospital

Daugavpils, Latvia, LV-5417

Status
Completed
 
Locations

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, Hungary, 6720

Status
Completed
 
Locations

Bacs-Kiskun Megyei Korhaz

Kalocsa, Hungary, 6300

Status
Completed
 
Locations

LLC B. Brown Avitum Russland Clinics

St. Petersburg, Russia, 196247

Status
Completed
 
Locations

Public Central Hospital of Matto Ishikawa

Hakusan, Japan, 924-8588

Status
Completed
 
Locations

Medical corporation association Shunshin-kai Inage hospital

Chiba, Japan, 263-0043

Status
Completed
 
Locations

Ibaraki Prefectural Central Hospital

Kasama, Japan, 309-1793

Status
Completed
 
Locations

Hanyu General Hospital

Hanyu, Japan, 348-0045

Status
Completed
 
Locations

Sapporo Tokushukai Hospital

Sapporo, Japan, 004-0041

Status
Completed
 
Locations

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Japan, 251-0041

Status
Completed
 
Locations

Matsunami General Hospital

Hashima-gun, Japan, 501-6062

Status
Completed
 
Locations

Salem VA Medical Center

Salem, United States, 24153

Status
Completed
 
Locations

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

Incheon, South Korea, 21431

Status
Completed
 
Locations

Yeouido St. Mary's Hospital

Seoul, South Korea, 150-713

Status
Completed
 
Locations

State Budgetary Healthcare Institution City Hospital #26

St. Petersburg, Russia, 196247

Status
Completed
 
Locations

Nikiforov All-Russian Center of Emergency and Radiation Med

Saint-Petersburg, Russia, 197374

Status
Completed
 
Locations

Botkin clinical infectious diseases hospital

St. Petersburg, Russia, 195067

Status
Completed
 
Locations

Taipei Medical University Hospital

Taipei, Taiwan, China, 110

Status
Completed
 
Locations

Chi Mei Medical Center

Tainan, Taiwan, China, 710

Status
Completed
 
Locations

Kyiv Regional Clinical Hospital

Kyiv, Ukraine, 04107

Status
Completed
 
Locations

Ternopil University Hospital

Ternopil, Ukraine, 46002

Status
Completed
 
Locations

DaVita Clinical Resarch Germany GmbH

Geilenkirchen, Germany, 52511

Status
Completed
 

Trial Design