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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)

Primary Purpose

End Stage Renal Disease Requiring Hemodialysis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fesomersen sodium (BAY2976217)
Placebo
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease Requiring Hemodialysis focused on measuring End stage renal disease (ESRD), Hemodialysis (HD), Thrombotic Events

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fresenius Kidney Care Clovis
  • Desert Cities Dialysis-Amethyst & Desert Cities Dialysis
  • Davita East Ft. Lauderdale Dialysis Center
  • Fresenius Kidney Care St. Louis Regional Dialysis
  • Chromalloy Dialysis Center
  • Fresenius Medical Care - Fire Mesa Dialysis Unit
  • DaVita Northwest Medical Center Dialysis
  • San Antonio Kidney Disease Center Physicians Group, PLLC
  • Salem VA Medical Center
  • OL Vrouwziekenhuis - Campus Aalst
  • UZ Brussel
  • UZ Antwerpen
  • Regionaal ZH Jan Yperman Campus Mariaziekenhuis
  • First Dialysis Services Bulgaria Ead
  • MHAT Samokov
  • MHAT "Knyaginya Klementina - Sofia"EAD
  • MHAT National Cardiology Hospital EAD
  • Etobicoke General Hospital
  • St. Joseph's Healthcare - Hamilton
  • Lakeridge Health-Oshawa
  • Unity Health Toronto: St. Michael's Hospital
  • Centre de services ambulatoires de dialyse de Gaspé
  • CHU de Québec-Université Laval
  • Nemocnice Frydek-Mistek
  • Klatovska nemocnice
  • Fresenius Medical Care - DS, s.r.o.
  • Oblastni nemocnice Mlada Boleslav
  • DaVita Clinical Research Deutschland GmbH
  • DaVita Clinical Resarch Germany GmbH
  • Universitätsklinikum Schleswig-Holstein (UKSH)
  • University General Hospital of Heraklion
  • University General Hospital of Patra
  • PAPANIKOLAOU General Hospital Thessaloniki
  • Bacs-Kiskun Megyei Korhaz
  • SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
  • Matsunami General Hospital
  • Sapporo Tokushukai Hospital
  • Ibaraki Prefectural Central Hospital
  • Public Central Hospital of Matto Ishikawa
  • Shonan Fujisawa Tokushukai Hospital
  • Hanyu General Hospital
  • Medical corporation association Shunshin-kai Inage hospital
  • The Catholic University of Korea, Incheon St.Mary's Hospital
  • Yeouido St. Mary's Hospital
  • Daugavpils Regional Hospital
  • Liepaja Regional Hospital
  • P. Stradins Clinical University Hospital
  • Vidzemes Hospital
  • High Technology Center Clinic 1
  • Limited Liability Company "Nefroline-Novosibirsk"
  • LLC Frezenius Nefrocare
  • LLC Dialysis center
  • Nikiforov All-Russian Center of Emergency and Radiation Med
  • Botkin clinical infectious diseases hospital
  • LLC B. Brown Avitum Russland Clinics
  • State Budgetary Healthcare Institution City Hospital #26
  • Hospital Principe de Asturias
  • Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention
  • Hospital Clínic i Provincial de Barcelona
  • Hospital Universitario Virgen de las Nieves|Nefrologia
  • Hospital Universitari i Politècnic La Fe | Nefrología
  • Chi Mei Medical Center
  • Taipei Medical University Hospital
  • Medical Center Fresenius Medical Care Ukraine, LLC
  • Kyiv City Center of Nephrology and Dialysis
  • Kyiv Regional Clinical Hospital
  • Regional Clinical Hospital - Odessa
  • Ternopil Regional Clinical Hospital
  • Zaporizhia Municipal Clinical Hospital No.10

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Pooled Placebo

40 mg BAY2976217

80 mg BAY2976217

120 mg BAY2976217

Arm Description

Participants received subcutaneous treatment with matching placebo.

Participants received subcutaneous treatment with 40 mg BAY2976217.

Participants received subcutaneous treatment with 80 mg BAY2976217.

Participants received subcutaneous treatment with 120 mg BAY2976217.

Outcomes

Primary Outcome Measures

Incidence of Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) During the Main Treatment Period and Within the On-treatment Time Window, as Assessed by Blinded Central Independent Adjudication Committee (CIAC)
MB is defined as symptomatic bleeding and: 1) Fatal bleeding, and/or; 2) Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3) Bleeding causing a fall in hemoglobin level of 20 g/L (2.0 g/dL) (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. CRNMB is defined as any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: 1) Requiring medical intervention by a healthcare professional; 2) Leading to hospitalization or increased level of care; 3) Prompting a face-to-face evaluation. n/100 person-years: number of subjects with incident events divided by the cumulative at-risk time in the reference population, where a subject is no longer at risk once an incident event occurred.

Secondary Outcome Measures

Incidence of Composite of MB and CRNMB During the Main and Extended Treatment Periods and Within the On-treatment Time Window, as Assessed by Blinded CIAC
MB is defined as symptomatic bleeding and: 1) Fatal bleeding, and/or; 2) Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3) Bleeding causing a fall in hemoglobin level of 20 g/L (2.0 g/dL) (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. CRNMB is defined as any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: 1) Requiring medical intervention by a healthcare professional; 2) Leading to hospitalization or increased level of care; 3) Prompting a face-to-face evaluation. n/100 person-years: number of subjects with incident events divided by the cumulative at-risk time in the reference population, where a subject is no longer at risk once an incident event occurred.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Main Treatment Period and Within the On-treatment Time Window and Their Severity
TEAEs were analyzed during the on-treatment time window within the main treatment period in the safety analysis set (SAF). Data observed from the randomization date until the end of the main treatment period. TEAEs were defined as events occurring after first study intervention administration and up to 20 weeks after last study intervention administration.
Number of Participants With TEAEs During the Main and Extended Treatment Periods and Within the On-treatment Time Window and Their Severity
TEAEs were analyzed during during main and extended treatment periods in the safety analysis set (SAF). Data observed from the randomization date until the end of the extension treatment period. TEAEs were defined as events occurring after first study intervention administration and up to 20 weeks after last study intervention administration.
Number of Participants With TEAEs During the Main and Extended Treatment Periods and Until 20 Weeks After the Last Study Intervention Dose and Their Severity
TEAEs occurring from first study intervention intake until 20 weeks after last study intervention intake.
Trough Concentrations (Ctrough) of Three Dose Levels of Fesomersen
Trough (pre-dose) fesomersen-equivalent plasma concentrations (Ctrough) for 3 dose levels of fesomersen were summarized descriptively by dose level and visit: Visit 12, Visit 14, Visit 16, Visit 18 (main treatment period). Ctrough was not measured for the placebo group.
Maximum Change in FXI (Coagulation Factor XI) Antigen Levels During the Main Treatment Period
The secondary endpoint of change in FXI antigen levels during the main treatment period was an optional secondary endpoint only as mentioned in the integrated clinical protocol amendment version 3.0 and was not analyzed in this study as the FXI activity assay is sufficient to describe the effect on FXI level in plasma.
Maximum Change in FXI Activity Levels During the Main Treatment Period
The FXIa activity was measured by a fluorogenic activated FXIa activity (AXIA) assay. Absolute change from baseline at each visit until Visit 22 (Day 169) are reported.

Full Information

First Posted
August 20, 2020
Last Updated
June 14, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT04534114
Brief Title
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
Acronym
RE-THINc ESRD
Official Title
Factor XI LICA to Reduce Thrombotic Events in End-Stage Renal Disease Patients on Hemodialysis: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of BAY 2976217
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
January 24, 2022 (Actual)
Study Completion Date
May 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease Requiring Hemodialysis
Keywords
End stage renal disease (ESRD), Hemodialysis (HD), Thrombotic Events

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
307 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pooled Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received subcutaneous treatment with matching placebo.
Arm Title
40 mg BAY2976217
Arm Type
Experimental
Arm Description
Participants received subcutaneous treatment with 40 mg BAY2976217.
Arm Title
80 mg BAY2976217
Arm Type
Experimental
Arm Description
Participants received subcutaneous treatment with 80 mg BAY2976217.
Arm Title
120 mg BAY2976217
Arm Type
Experimental
Arm Description
Participants received subcutaneous treatment with 120 mg BAY2976217.
Intervention Type
Drug
Intervention Name(s)
Fesomersen sodium (BAY2976217)
Other Intervention Name(s)
Factor XI LICA
Intervention Description
Study intervention will be injected subcutaneously.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo to BAY2976217 will be injected subcutaneously.
Primary Outcome Measure Information:
Title
Incidence of Composite of Major Bleeding (MB) and Clinically-relevant Non-major Bleeding (CRNMB) During the Main Treatment Period and Within the On-treatment Time Window, as Assessed by Blinded Central Independent Adjudication Committee (CIAC)
Description
MB is defined as symptomatic bleeding and: 1) Fatal bleeding, and/or; 2) Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3) Bleeding causing a fall in hemoglobin level of 20 g/L (2.0 g/dL) (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. CRNMB is defined as any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: 1) Requiring medical intervention by a healthcare professional; 2) Leading to hospitalization or increased level of care; 3) Prompting a face-to-face evaluation. n/100 person-years: number of subjects with incident events divided by the cumulative at-risk time in the reference population, where a subject is no longer at risk once an incident event occurred.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Incidence of Composite of MB and CRNMB During the Main and Extended Treatment Periods and Within the On-treatment Time Window, as Assessed by Blinded CIAC
Description
MB is defined as symptomatic bleeding and: 1) Fatal bleeding, and/or; 2) Bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or; 3) Bleeding causing a fall in hemoglobin level of 20 g/L (2.0 g/dL) (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells. CRNMB is defined as any sign or symptom of hemorrhage that does not fit the criteria for the ISTH definition of major bleeding but does meet at least one of the following criteria: 1) Requiring medical intervention by a healthcare professional; 2) Leading to hospitalization or increased level of care; 3) Prompting a face-to-face evaluation. n/100 person-years: number of subjects with incident events divided by the cumulative at-risk time in the reference population, where a subject is no longer at risk once an incident event occurred.
Time Frame
Up to 48 weeks
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Main Treatment Period and Within the On-treatment Time Window and Their Severity
Description
TEAEs were analyzed during the on-treatment time window within the main treatment period in the safety analysis set (SAF). Data observed from the randomization date until the end of the main treatment period. TEAEs were defined as events occurring after first study intervention administration and up to 20 weeks after last study intervention administration.
Time Frame
Up to 24 weeks
Title
Number of Participants With TEAEs During the Main and Extended Treatment Periods and Within the On-treatment Time Window and Their Severity
Description
TEAEs were analyzed during during main and extended treatment periods in the safety analysis set (SAF). Data observed from the randomization date until the end of the extension treatment period. TEAEs were defined as events occurring after first study intervention administration and up to 20 weeks after last study intervention administration.
Time Frame
Up to 48 weeks
Title
Number of Participants With TEAEs During the Main and Extended Treatment Periods and Until 20 Weeks After the Last Study Intervention Dose and Their Severity
Description
TEAEs occurring from first study intervention intake until 20 weeks after last study intervention intake.
Time Frame
Up to 48 weeks
Title
Trough Concentrations (Ctrough) of Three Dose Levels of Fesomersen
Description
Trough (pre-dose) fesomersen-equivalent plasma concentrations (Ctrough) for 3 dose levels of fesomersen were summarized descriptively by dose level and visit: Visit 12, Visit 14, Visit 16, Visit 18 (main treatment period). Ctrough was not measured for the placebo group.
Time Frame
At visits V12 (Day 57), V14 (Day 85), V16 (Day 113), V18 (Day 141)
Title
Maximum Change in FXI (Coagulation Factor XI) Antigen Levels During the Main Treatment Period
Description
The secondary endpoint of change in FXI antigen levels during the main treatment period was an optional secondary endpoint only as mentioned in the integrated clinical protocol amendment version 3.0 and was not analyzed in this study as the FXI activity assay is sufficient to describe the effect on FXI level in plasma.
Time Frame
Up to 24 weeks
Title
Maximum Change in FXI Activity Levels During the Main Treatment Period
Description
The FXIa activity was measured by a fluorogenic activated FXIa activity (AXIA) assay. Absolute change from baseline at each visit until Visit 22 (Day 169) are reported.
Time Frame
Baseline, Days 1 (Pre-Dose and 5 hours post-dose), 2, 8, 15, 22, 29 (Pre-dose and 5 hours post-dose), 43, 57 (Pre-dose), 71, 85 (Pre-dose), 113 (Pre-dose), 141 (Pre-dose),148, 155, 162, and 169 (Pre-dose)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Fresenius Kidney Care Clovis
City
Clovis
State/Province
California
ZIP/Postal Code
93611
Country
United States
Facility Name
Desert Cities Dialysis-Amethyst & Desert Cities Dialysis
City
Victorville
State/Province
California
ZIP/Postal Code
92392
Country
United States
Facility Name
Davita East Ft. Lauderdale Dialysis Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Fresenius Kidney Care St. Louis Regional Dialysis
City
Saint Ann
State/Province
Missouri
ZIP/Postal Code
63074
Country
United States
Facility Name
Chromalloy Dialysis Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Fresenius Medical Care - Fire Mesa Dialysis Unit
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
DaVita Northwest Medical Center Dialysis
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
San Antonio Kidney Disease Center Physicians Group, PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Salem VA Medical Center
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
OL Vrouwziekenhuis - Campus Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
UZ Brussel
City
Bruxelles - Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Regionaal ZH Jan Yperman Campus Mariaziekenhuis
City
Ieper
ZIP/Postal Code
8900
Country
Belgium
Facility Name
First Dialysis Services Bulgaria Ead
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
MHAT Samokov
City
Samokov
ZIP/Postal Code
2000
Country
Bulgaria
Facility Name
MHAT "Knyaginya Klementina - Sofia"EAD
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
MHAT National Cardiology Hospital EAD
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
Etobicoke General Hospital
City
Etobicoke
State/Province
Ontario
ZIP/Postal Code
M9V 1R8
Country
Canada
Facility Name
St. Joseph's Healthcare - Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Lakeridge Health-Oshawa
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Unity Health Toronto: St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Centre de services ambulatoires de dialyse de Gaspé
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2T 3B3
Country
Canada
Facility Name
CHU de Québec-Université Laval
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Nemocnice Frydek-Mistek
City
Frydek-Mistek
ZIP/Postal Code
738 01
Country
Czechia
Facility Name
Klatovska nemocnice
City
Klatovy
ZIP/Postal Code
339 01
Country
Czechia
Facility Name
Fresenius Medical Care - DS, s.r.o.
City
Melnik
ZIP/Postal Code
276 01
Country
Czechia
Facility Name
Oblastni nemocnice Mlada Boleslav
City
Mlada Boleslav
ZIP/Postal Code
293 50
Country
Czechia
Facility Name
DaVita Clinical Research Deutschland GmbH
City
Duesseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40210
Country
Germany
Facility Name
DaVita Clinical Resarch Germany GmbH
City
Geilenkirchen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52511
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein (UKSH)
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
University General Hospital of Heraklion
City
Heraklion
ZIP/Postal Code
711 10
Country
Greece
Facility Name
University General Hospital of Patra
City
Patra
ZIP/Postal Code
26504
Country
Greece
Facility Name
PAPANIKOLAOU General Hospital Thessaloniki
City
Pilea Chortiatis
ZIP/Postal Code
57010
Country
Greece
Facility Name
Bacs-Kiskun Megyei Korhaz
City
Kalocsa
ZIP/Postal Code
6300
Country
Hungary
Facility Name
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Matsunami General Hospital
City
Hashima-gun
State/Province
Gifu
ZIP/Postal Code
501-6062
Country
Japan
Facility Name
Sapporo Tokushukai Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
004-0041
Country
Japan
Facility Name
Ibaraki Prefectural Central Hospital
City
Kasama
State/Province
Ibaraki
ZIP/Postal Code
309-1793
Country
Japan
Facility Name
Public Central Hospital of Matto Ishikawa
City
Hakusan
State/Province
Ishikawa
ZIP/Postal Code
924-8588
Country
Japan
Facility Name
Shonan Fujisawa Tokushukai Hospital
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-0041
Country
Japan
Facility Name
Hanyu General Hospital
City
Hanyu
State/Province
Saitama
ZIP/Postal Code
348-0045
Country
Japan
Facility Name
Medical corporation association Shunshin-kai Inage hospital
City
Chiba
ZIP/Postal Code
263-0043
Country
Japan
Facility Name
The Catholic University of Korea, Incheon St.Mary's Hospital
City
Incheon
State/Province
Incheon Gwang''yeogsi
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Yeouido St. Mary's Hospital
City
Seoul
State/Province
Seoul Teugbyeolsi
ZIP/Postal Code
150-713
Country
Korea, Republic of
Facility Name
Daugavpils Regional Hospital
City
Daugavpils
ZIP/Postal Code
LV-5417
Country
Latvia
Facility Name
Liepaja Regional Hospital
City
Liepaja
ZIP/Postal Code
LV-3414
Country
Latvia
Facility Name
P. Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Vidzemes Hospital
City
Valmiera
ZIP/Postal Code
LV-4201
Country
Latvia
Facility Name
High Technology Center Clinic 1
City
Moscow
ZIP/Postal Code
125466
Country
Russian Federation
Facility Name
Limited Liability Company "Nefroline-Novosibirsk"
City
Novosibirsk
ZIP/Postal Code
630064
Country
Russian Federation
Facility Name
LLC Frezenius Nefrocare
City
Penza
ZIP/Postal Code
440034
Country
Russian Federation
Facility Name
LLC Dialysis center
City
Podolsk
ZIP/Postal Code
142110
Country
Russian Federation
Facility Name
Nikiforov All-Russian Center of Emergency and Radiation Med
City
Saint-Petersburg
ZIP/Postal Code
197374
Country
Russian Federation
Facility Name
Botkin clinical infectious diseases hospital
City
St. Petersburg
ZIP/Postal Code
195067
Country
Russian Federation
Facility Name
LLC B. Brown Avitum Russland Clinics
City
St. Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution City Hospital #26
City
St. Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Hospital Principe de Asturias
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Clínic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves|Nefrologia
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe | Nefrología
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Chi Mei Medical Center
City
Tainan
ZIP/Postal Code
710
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei
ZIP/Postal Code
110
Country
Taiwan
Facility Name
Medical Center Fresenius Medical Care Ukraine, LLC
City
Chernigiv
ZIP/Postal Code
14034
Country
Ukraine
Facility Name
Kyiv City Center of Nephrology and Dialysis
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Facility Name
Kyiv Regional Clinical Hospital
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
Regional Clinical Hospital - Odessa
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Ternopil Regional Clinical Hospital
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Zaporizhia Municipal Clinical Hospital No.10
City
Zaporizhzhya
ZIP/Postal Code
69001
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no current plans to share data. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Links:
URL
https://clinicaltrials.bayer.com/
Description
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.
URL
http://www.clinicaltrialsregister.eu/
Description
Click here to find information about studies related to Bayer AG products conducted in Europe.

Learn more about this trial

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

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