End Stage Renal Disease Requiring HemodialysisPhase 2RE-THINc ESRDNCT04534114
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
A Phase 2 study testing Fesomersen sodium (BAY2976217) in people with End Stage Renal Disease Requiring Hemodialysis, run by Bayer at 69 sites in 15 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease Requiring Hemodialysis
- What is being tested?
- Fesomersen sodium (BAY2976217)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 307 participants
- Where
- 69 sitesin 15 countries
- Study dates
- 4 Sep 2020to 12 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
69 sites in 15 countries.
69 sites in 15 countries
United States9 sites
Fresenius Kidney Care Clovis
Clovis, California, 93611
Davita East Ft. Lauderdale Dialysis Center
Fort Lauderdale, Florida, 33316
Fresenius Medical Care - Fire Mesa Dialysis Unit
Las Vegas, Nevada, 89128
Fresenius Kidney Care St. Louis Regional Dialysis
Saint Ann, Missouri, 63074
Salem VA Medical Center
Salem, Virginia, 24153
DaVita Northwest Medical Center Dialysis
San Antonio, Texas, 78229
San Antonio Kidney Disease Center Physicians Group, PLLC
San Antonio, Texas, 78258
Chromalloy Dialysis Center
St Louis, Missouri, 63110
Desert Cities Dialysis-Amethyst & Desert Cities Dialysis
Victorville, California, 92392
Russia8 sites
High Technology Center Clinic 1
Moscow, 125466
Limited Liability Company "Nefroline-Novosibirsk"
Novosibirsk, 630064
LLC Frezenius Nefrocare
Penza, 440034
LLC Dialysis center
Podolsk, 142110
Botkin clinical infectious diseases hospital
Saint Petersburg, 195067
LLC B. Brown Avitum Russland Clinics
Saint Petersburg, 196247
State Budgetary Healthcare Institution City Hospital #26
Saint Petersburg, 196247
Nikiforov All-Russian Center of Emergency and Radiation Med
Saint Petersburg, 197374
Japan7 sites
Medical corporation association Shunshin-kai Inage hospital
Chiba, 263-0043
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, 251-0041
Public Central Hospital of Matto Ishikawa
Hakusan, Ishikawa-ken, 924-8588
Hanyu General Hospital
Hanyū, Saitama, 348-0045
Matsunami General Hospital
Hashima-gun, Gifu, 501-6062
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, 309-1793
Sapporo Tokushukai Hospital
Sapporo, Hokkaido, 004-0041
Canada6 sites
Etobicoke General Hospital
Etobicoke, Ontario, M9V 1R8
St. Joseph's Healthcare - Hamilton
Hamilton, Ontario, L8N 4A6
Centre de services ambulatoires de dialyse de Gaspé
Montreal, Quebec, H2T 3B3
Lakeridge Health-Oshawa
Oshawa, Ontario, L1G 2B9
CHU de Québec-Université Laval
Québec, G1J 1Z4
Unity Health Toronto: St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Ukraine6 sites
Medical Center Fresenius Medical Care Ukraine, LLC
Chernihiv, 14034
Kyiv City Center of Nephrology and Dialysis
Kyiv, 01023
Kyiv Regional Clinical Hospital
Kyiv, 04107
Regional Clinical Hospital - Odessa
Odesa, 65025
Ternopil Regional Clinical Hospital
Ternopil, 46002
Zaporizhia Municipal Clinical Hospital No.10
Zaporizhzhya, 69001
Spain5 sites
Hospital Principe de Asturias
Alcalá de Henares, Madrid, 28805
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention
Barcelona, 08907
Hospital Clínic i Provincial de Barcelona
Barcelona, 8036
Hospital Universitario Virgen de las Nieves|Nefrologia
Granada, 18014
Hospital Universitari i Politècnic La Fe | Nefrología
Valencia, 46026
Belgium4 sites
OL Vrouwziekenhuis - Campus Aalst
Aalst, 9300
UZ Brussel
Bruxelles - Brussel, 1090
UZ Antwerpen
Edegem, 2650
Regionaal ZH Jan Yperman Campus Mariaziekenhuis
Ieper, 8900
Bulgaria4 sites
First Dialysis Services Bulgaria Ead
Montana, 3400
MHAT Samokov
Samokov, 2000
MHAT "Knyaginya Klementina - Sofia"EAD
Sofia, 1233
MHAT National Cardiology Hospital EAD
Sofia, 1309
Czechia4 sites
Nemocnice Frydek-Mistek
Frýdek-Místek, 738 01
Klatovska nemocnice
Klatovy, 339 01
Fresenius Medical Care - DS, s.r.o.
Mělník, 276 01
Oblastni nemocnice Mlada Boleslav
Mladá Boleslav, 293 50
Latvia4 sites
Daugavpils Regional Hospital
Daugavpils, LV-5417
Liepaja Regional Hospital
Liepāja, LV-3414
P. Stradins Clinical University Hospital
Riga, LV-1002
Vidzemes Hospital
Valmiera, LV-4201
Germany3 sites
DaVita Clinical Research Deutschland GmbH
Düsseldorf, North Rhine-Westphalia, 40210
DaVita Clinical Resarch Germany GmbH
Geilenkirchen, North Rhine-Westphalia, 52511
Universitätsklinikum Schleswig-Holstein (UKSH)
Kiel, Schleswig-Holstein, 24105
Greece3 sites
University General Hospital of Heraklion
Heraklion, 711 10
University General Hospital of Patra
Pátrai, 26504
PAPANIKOLAOU General Hospital Thessaloniki
Pilea Chortiatis, 57010
Hungary2 sites
Bacs-Kiskun Megyei Korhaz
Kalocsa, 6300
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont
Szeged, 6720
South Korea2 sites
The Catholic University of Korea, Incheon St.Mary's Hospital
Incheon, Incheon Gwang''yeogsi, 21431
Yeouido St. Mary's Hospital
Seoul, Seoul Teugbyeolsi, 150-713
Taiwan2 sites
Chi Mei Medical Center
Tainan, 710
Taipei Medical University Hospital
Taipei, 110
About this study
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
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.
- Being tested
- Fesomersen sodium (BAY2976217), Placebo
- Keywords
- End stage renal disease (ESRD), Hemodialysis (HD), Thrombotic Events
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fesomersen sodium (BAY2976217)Drug
Also called Factor XI LICA
Study intervention will be injected subcutaneously.
PlaceboDrug
Matching placebo to BAY2976217 will be injected subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Pooled Placebo | Placebo comparator | Participants received subcutaneous treatment with matching placebo. Receives: Drug: Placebo |
| 40 mg BAY2976217 | Experimental | Participants received subcutaneous treatment with 40 mg BAY2976217. Receives: Drug: Fesomersen sodium (BAY2976217) |
| 80 mg BAY2976217 | Experimental | Participants received subcutaneous treatment with 80 mg BAY2976217. Receives: Drug: Fesomersen sodium (BAY2976217) |
| 120 mg BAY2976217 | Experimental | Participants received subcutaneous treatment with 120 mg BAY2976217. Receives: Drug: Fesomersen sodium (BAY2976217) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 24 weeks
Secondary outcomes (7)
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.
Measured: Up to 48 weeks
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.
Measured: Up to 24 weeks
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.
Measured: Up to 48 weeks
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.
Measured: Up to 48 weeks
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.
Measured: At visits V12 (Day 57), V14 (Day 85), V16 (Day 113), V18 (Day 141)
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.
Measured: Up to 24 weeks
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start4 Sep 2020
- Primary completion24 Jan 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease Requiring HemodialysisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534114
- Sponsor's protocol ID
- 21170
- Other IDs
- 2019-003927-39, 2019
- Acronym
- RE-THINc ESRD
- Status last verified
- Jun 2023
- First submitted
- 20 Aug 2020
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38906653Winkelmayer 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.
PubMed 38537676
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04534114
- Acronym / sponsor ID
- RE-THINc ESRD / 21170
- Keywords
- End stage renal disease (ESRD), Hemodialysis (HD), Thrombotic Events
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Posted 3 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pooled Placebo | Placebo comparator | Drug: PlaceboParticipants received subcutaneous treatment with matching placebo. |
| 40 mg BAY2976217 | Experimental | Drug: Fesomersen sodium (BAY2976217)Participants received subcutaneous treatment with 40 mg BAY2976217. |
| 80 mg BAY2976217 | Experimental | Drug: Fesomersen sodium (BAY2976217)Participants received subcutaneous treatment with 80 mg BAY2976217. |
| 120 mg BAY2976217 | Experimental | Drug: Fesomersen sodium (BAY2976217)Participants received subcutaneous treatment with 120 mg BAY2976217. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fesomersen sodium (BAY2976217)Also: Factor XI LICAStudy intervention will be injected subcutaneously. | Drug | 120 mg BAY2976217, 40 mg BAY2976217, 80 mg BAY2976217 |
| PlaceboMatching placebo to BAY2976217 will be injected subcutaneously. | Drug | Pooled Placebo |
Primary outcome
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)
Time frame: Up to 24 weeks
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.
7 secondary outcomes
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
Time frame: Up to 48 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Main Treatment Period and Within the On-treatment Time Window and Their Severity
Time frame: Up to 24 weeks
Number of Participants With TEAEs During the Main and Extended Treatment Periods and Within the On-treatment Time Window and Their Severity
Time frame: Up to 48 weeks
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
Time frame: Up to 48 weeks
Trough Concentrations (Ctrough) of Three Dose Levels of Fesomersen
Time frame: At visits V12 (Day 57), V14 (Day 85), V16 (Day 113), V18 (Day 141)
Maximum Change in FXI (Coagulation Factor XI) Antigen Levels During the Main Treatment Period
Time frame: Up to 24 weeks
Maximum Change in FXI Activity Levels During the Main Treatment Period
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38906653Stamellou 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.
- Derived from this study: PubMed 38537676Winkelmayer 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.
- Click here to find information about studies related to Bayer AG products conducted in Europe.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
69 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fesomersen sodium (BAY2976217) in people with End Stage Renal Disease Requiring Hemodialysis, run by Bayer at 69 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States, Russia, Japan, Canada, Ukraine and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534114, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.