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:
EudraCT Number:
EU CT Number:
Not Available
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 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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
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Locations DaVita Clinical Research Deutschland GmbH Duesseldorf, Germany, 40210 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Schleswig-Holstein (UKSH) Kiel, Germany, 24105 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Northwest Medical Center Dialysis San Antonio, United States, 78229 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care - Fire Mesa Dialysis Unit Las Vegas, United States, 89128 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations San Antonio Kidney Disease Center Physicians Group, PLLC San Antonio, United States, 78258 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chromalloy Dialysis Center St. Louis, United States, 63110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Desert Cities Dialysis-Amethyst & Desert Cities Dialysis Victorville, United States, 92392 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care Clovis Clovis, United States, 93611 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care St. Louis Regional Dialysis St. Ann, United States, 63074 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Davita East Ft. Lauderdale Dialysis Center Ft. Lauderdale, United States, 33316 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de las Nieves|Nefrologia Granada, Spain, 18014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 8036 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari i Politècnic La Fe | Nefrología Valencia, Spain, 46026 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology - AF, Stroke Prevention Barcelona, Spain, 08907 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Principe de Asturias Alcalá de Henares, Spain, 28805 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lakeridge Health-Oshawa Oshawa, Canada, L1G 2B9 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Etobicoke General Hospital Etobicoke, Canada, M9V 1R8 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Joseph's Healthcare - Hamilton Hamilton, Canada, L8N 4A6 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Unity Health Toronto: St. Michael's Hospital Toronto, Canada, M5B 1W8 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Québec-Université Laval Quebec, Canada, G1J 1Z4 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre de services ambulatoires de dialyse de Gaspé Montreal, Canada, H2T 3B3 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regionaal ZH Jan Yperman Campus Mariaziekenhuis IEPER, Belgium, 8900 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Antwerpen EDEGEM, Belgium, 2650 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Brussel BRUXELLES - BRUSSEL, Belgium, 1090 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OL Vrouwziekenhuis - Campus Aalst Aalst, Belgium, 9300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oblastni nemocnice Mlada Boleslav Mlada Boleslav, Czech Republic, 293 50 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Frydek-Mistek Frydek-Mistek, Czech Republic, 738 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klatovska nemocnice Klatovy, Czech Republic, 339 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care - DS, s.r.o. Melnik, Czech Republic, 276 01 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT "Knyaginya Klementina - Sofia"EAD Sofia, Bulgaria, 1233 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT National Cardiology Hospital EAD Sofia, Bulgaria, 1309 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FIRST DIALYSIS SERVICES BULGARIA EAD Montana, Bulgaria, 3400 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Samokov Samokov, Bulgaria, 2000 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Patra Patra, Greece, 26504 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PAPANIKOLAOU General Hospital Thessaloniki Pilea Chortiatis, Greece, 57010 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Heraklion Heraklion, Greece, 711 10 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Limited Liability Company "Nefroline-Novosibirsk" Novosibirsk, Russia, 630064 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Dialysis center Podolsk, Russia, 142110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations High Technology Center Clinic 1 Moscow, Russia, 125466 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Frezenius Nefrocare Penza, Russia, 440034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyiv City Center of Nephrology and Dialysis Kyiv, Ukraine, 01023 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zaporizhia Municipal Clinical Hospital No.10 Zaporizhzhya, Ukraine, 69001 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regional Clinical Hospital - Odessa Odesa, Ukraine, 65025 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Center Fresenius Medical Care Ukraine, LLC Chernigiv, Ukraine, 14034 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations P. Stradins Clinical University Hospital Riga, Latvia, LV-1002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vidzemes Hospital Valmiera, Latvia, LV-4201 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liepaja Regional Hospital Liepaja, Latvia, LV-3414 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Daugavpils Regional Hospital Daugavpils, Latvia, LV-5417 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged, Hungary, 6720 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bacs-Kiskun Megyei Korhaz Kalocsa, Hungary, 6300 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC B. Brown Avitum Russland Clinics St. Petersburg, Russia, 196247 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Public Central Hospital of Matto Ishikawa Hakusan, Japan, 924-8588 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical corporation association Shunshin-kai Inage hospital Chiba, Japan, 263-0043 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ibaraki Prefectural Central Hospital Kasama, Japan, 309-1793 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hanyu General Hospital Hanyu, Japan, 348-0045 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Sapporo Tokushukai Hospital Sapporo, Japan, 004-0041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Shonan Fujisawa Tokushukai Hospital Fujisawa, Japan, 251-0041 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Matsunami General Hospital Hashima-gun, Japan, 501-6062 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Salem VA Medical Center Salem, United States, 24153 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations The Catholic University of Korea, Incheon St.Mary's Hospital Incheon, South Korea, 21431 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Yeouido St. Mary's Hospital Seoul, South Korea, 150-713 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations State Budgetary Healthcare Institution City Hospital #26 St. Petersburg, Russia, 196247 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nikiforov All-Russian Center of Emergency and Radiation Med Saint-Petersburg, Russia, 197374 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Botkin clinical infectious diseases hospital St. Petersburg, Russia, 195067 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Taipei Medical University Hospital Taipei, Taiwan, China, 110 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chi Mei Medical Center Tainan, Taiwan, China, 710 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyiv Regional Clinical Hospital Kyiv, Ukraine, 04107 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ternopil Regional Clinical Hospital Ternopil, Ukraine, 46002 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Clinical Resarch Germany GmbH Geilenkirchen, Germany, 52511 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
4
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)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.Timeframe: Up to 24 weeks
Secondary Outcome
- 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 CIACMB 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.Timeframe: 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 severityTEAEs 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.Timeframe: 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 severityTEAEs 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.Timeframe: 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 severityTEAEs occurring from first study intervention intake until 20 weeks after last study intervention intake.Timeframe: Up to 48 weeks
- Trough concentrations (Ctrough) of three dose levels of fesomersenTrough (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.Timeframe: 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 periodThe 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.Timeframe: Up to 24 weeks
- Maximum change in FXI activity levels during the main treatment periodThe 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.Timeframe: 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)
Additional Information
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