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

NCT ID: NCT04534114

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 307 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-04
• Study Completion Date: 2022-05-12

Brief Summary

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.

Conditions

End Stage Renal Disease Requiring Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Pooled Placebo

Participants received subcutaneous treatment with matching placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo to BAY2976217 will be injected subcutaneously.

40 mg BAY2976217

Participants received subcutaneous treatment with 40 mg BAY2976217.

Group Type: EXPERIMENTAL

Fesomersen sodium (BAY2976217)

Intervention Type: DRUG

Study intervention will be injected subcutaneously.

80 mg BAY2976217

Participants received subcutaneous treatment with 80 mg BAY2976217.

Group Type: EXPERIMENTAL

Fesomersen sodium (BAY2976217)

Intervention Type: DRUG

Study intervention will be injected subcutaneously.

120 mg BAY2976217

Participants received subcutaneous treatment with 120 mg BAY2976217.

Group Type: EXPERIMENTAL

Fesomersen sodium (BAY2976217)

Intervention Type: DRUG

Study intervention will be injected subcutaneously.

Interventions

Fesomersen sodium (BAY2976217)

Study intervention will be injected subcutaneously.

Intervention Type: DRUG

Placebo

Matching placebo to BAY2976217 will be injected subcutaneously.

Intervention Type: DRUG

Other Intervention Names

Factor XI LICA

Eligibility Criteria

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 mm^3 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 BAY2306001/ISIS 416858 and BAY2976217/ 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fresenius Kidney Care Clovis

Clovis, California, United States

Desert Cities Dialysis-Amethyst & Desert Cities Dialysis

Victorville, California, United States

Davita East Ft. Lauderdale Dialysis Center

Fort Lauderdale, Florida, United States

Fresenius Kidney Care St. Louis Regional Dialysis

Saint Ann, Missouri, United States

Chromalloy Dialysis Center

St Louis, Missouri, United States

Fresenius Medical Care - Fire Mesa Dialysis Unit

Las Vegas, Nevada, United States

DaVita Northwest Medical Center Dialysis

San Antonio, Texas, United States

San Antonio Kidney Disease Center Physicians Group, PLLC

San Antonio, Texas, United States

Salem VA Medical Center

Salem, Virginia, United States

OL Vrouwziekenhuis - Campus Aalst

Aalst, , Belgium

UZ Brussel

Bruxelles - Brussel, , Belgium

UZ Antwerpen

Edegem, , Belgium

Regionaal ZH Jan Yperman Campus Mariaziekenhuis

Ieper, , Belgium

First Dialysis Services Bulgaria Ead

Montana, , Bulgaria

MHAT Samokov

Samokov, , Bulgaria

MHAT "Knyaginya Klementina - Sofia"EAD

Sofia, , Bulgaria

MHAT National Cardiology Hospital EAD

Sofia, , Bulgaria

Etobicoke General Hospital

Etobicoke, Ontario, Canada

St. Joseph's Healthcare - Hamilton

Hamilton, Ontario, Canada

Lakeridge Health-Oshawa

Oshawa, Ontario, Canada

Unity Health Toronto: St. Michael's Hospital

Toronto, Ontario, Canada

Centre de services ambulatoires de dialyse de Gaspé

Montreal, Quebec, Canada

CHU de Québec-Université Laval

Québec, , Canada

Nemocnice Frydek-Mistek

Frýdek-Místek, , Czechia

Klatovska nemocnice

Klatovy, , Czechia

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

Mělník, , Czechia

Oblastni nemocnice Mlada Boleslav

Mladá Boleslav, , Czechia

DaVita Clinical Research Deutschland GmbH

Düsseldorf, North Rhine-Westphalia, Germany

DaVita Clinical Resarch Germany GmbH

Geilenkirchen, North Rhine-Westphalia, Germany

Universitätsklinikum Schleswig-Holstein (UKSH)

Kiel, Schleswig-Holstein, Germany

University General Hospital of Heraklion

Heraklion, , Greece

University General Hospital of Patra

Pátrai, , Greece

PAPANIKOLAOU General Hospital Thessaloniki

Pilea Chortiatis, , Greece

Bacs-Kiskun Megyei Korhaz

Kalocsa, , Hungary

SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont

Szeged, , Hungary

Matsunami General Hospital

Hashima-gun, Gifu, Japan

Sapporo Tokushukai Hospital

Sapporo, Hokkaido, Japan

Ibaraki Prefectural Central Hospital

Kasama, Ibaraki, Japan

Public Central Hospital of Matto Ishikawa

Hakusan, Ishikawa-ken, Japan

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, Japan

Hanyu General Hospital

Hanyū, Saitama, Japan

Medical corporation association Shunshin-kai Inage hospital

Chiba, , Japan

Daugavpils Regional Hospital

Daugavpils, , Latvia

Liepaja Regional Hospital

Liepāja, , Latvia

P. Stradins Clinical University Hospital

Riga, , Latvia

Vidzemes Hospital

Valmiera, , Latvia

High Technology Center Clinic 1

Moscow, , Russia

Limited Liability Company "Nefroline-Novosibirsk"

Novosibirsk, , Russia

LLC Frezenius Nefrocare

Penza, , Russia

LLC Dialysis center

Podolsk, , Russia

Botkin clinical infectious diseases hospital

Saint Petersburg, , Russia

LLC B. Brown Avitum Russland Clinics

Saint Petersburg, , Russia

State Budgetary Healthcare Institution City Hospital #26

Saint Petersburg, , Russia

Nikiforov All-Russian Center of Emergency and Radiation Med

Saint Petersburg, , Russia

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

Incheon, Incheon Gwang''yeogsi, South Korea

Yeouido St. Mary's Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Hospital Principe de Asturias

Alcalá de Henares, Madrid, Spain

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

Barcelona, , Spain

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Hospital Universitario Virgen de las Nieves|Nefrologia

Granada, , Spain

Hospital Universitari i Politècnic La Fe | Nefrología

Valencia, , Spain

Chi Mei Medical Center

Tainan City, , Taiwan

Taipei Medical University Hospital

Taipei, , Taiwan

Medical Center Fresenius Medical Care Ukraine, LLC

Chernihiv, , Ukraine

Kyiv City Center of Nephrology and Dialysis

Kyiv, , Ukraine

Kyiv Regional Clinical Hospital

Kyiv, , Ukraine

Regional Clinical Hospital - Odessa

Odesa, , Ukraine

Ternopil Regional Clinical Hospital

Ternopil, , Ukraine

Zaporizhia Municipal Clinical Hospital No.10

Zaporizhzhya, , Ukraine

Countries

United States; Belgium; Bulgaria; Canada; Czechia; Germany; Greece; Hungary; Japan; Latvia; Russia; South Korea; Spain; Taiwan; Ukraine

References

Stamellou E, Noels H, Floege J. Factor XI inhibition in hemodialysis patients: the safer anticoagulation? Kidney Int. 2024 Jul;106(1):21-23. doi: 10.1016/j.kint.2024.03.029.

Reference Type: DERIVED

PMID: 38906653 (View on PubMed)

Winkelmayer WC, Lensing AWA, Thadhani RI, Mahaffey KW, Walsh M, Pap AF, Willmann S, Thelen K, Hodge S, Solms A, Ingham SJM, Eikelboom J; RE-THINC investigators. A Phase II randomized controlled trial evaluated antithrombotic treatment with fesomersen in patients with kidney failure on hemodialysis. Kidney Int. 2024 Jul;106(1):145-153. doi: 10.1016/j.kint.2024.02.024. Epub 2024 Mar 26.

Reference Type: DERIVED

PMID: 38537676 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://clinicaltrials.bayer.com/

Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

http://www.clinicaltrialsregister.eu/

Click here to find information about studies related to Bayer AG products conducted in Europe.

Other Identifiers

2019-003927-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

21170

Identifier Type: -

Identifier Source: org_study_id