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 mm3 at screening - Known hypersensitivity to the investigational drug or to inactive constituents of the study intervention - Active malignancy requiring treatment during study participation (except non-melanoma skin cancer, or cervical carcinoma in situ) - Participation in a study with an investigational medicinal product within 30 days or within 5 half-lives of the previous administered drug, whichever is longer, prior to the screening/observational period (Note: Participants from previous BAY 2306001/ISIS 416858 and BAY 2976217/ ION 957943 studies are eligible) - Any other conditions, which, in the opinion of the investigator or Sponsor would make the subject unsuitable for inclusion - Confirmed pregnancy
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Robert-Bosch-Krankenhaus Stuttgart, Germany, 70376 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nephrologisches Zentrum Hoyerswerda Hoyerswerda, Germany, 02977 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Clinical Research Deutschland GmbH Düsseldorf, Germany, 40210 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Universitätsklinikum Schleswig-Holstein (UKSH) Kiel, Germany, 24105 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Northwest Medical Center Dialysis San Antonio, United States, 78229 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Med Center Dialysis Houston, United States, 77004 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Minneapolis Diaysis Unit Minneapolis, United States, 55404 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care - Fire Mesa Dialysis Unit Las Vegas, United States, 89128 | Status Not yet recruiting | 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 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Chromalloy Dialysis Center St. Louis, United States, 63110 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations DaVita Orlando North Dialysis Orlando, United States, 32804 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Desert Cities Dialysis-Amethyst & Desert Cities Dialysis Victorville, United States, 92392 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care Clovis Clovis, United States, 93611 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Kidney Care St. Louis Regional Dialysis St. Ann, United States, 63074 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Davita East Ft. Lauderdale Dialysis Center Ft. Lauderdale, United States, 33316 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Elixia At Clinical Renal Associates Upland, United States, 19013 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care Tampa North Temple Terrace, United States, 33637 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitario Virgen de las Nieves Granada, Spain, 18014 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Sant Joan Despi Moises Broggi Sant Joan Despi, Spain, 08970 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital General Universitario Gregorio Marañón Madrid, Spain, 28007 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Ciutat Sanitària i Universitària de Bellvitge L'Hospitalet de Llobregat, Spain, 08907 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hospital Principe de Asturias Alcalá de Henares, Spain, 28805 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Complejo Hospitalario de Navarra Pamplona, Spain, 31008 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Lakeridge Health-Oshawa Oshawa, Canada, L1G 2B9 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Humber River Hospital Toronto, Canada, M3M 0B2 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Etobicoke General Hospital Etobicoke, Canada, M9V 1R8 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Joseph's Healthcare - Hamilton Hamilton, Canada, L8N 4A6 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Hopital Charles LeMoyne Greenfield Park, Canada, J4V 2H1 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations St. Michael's Healthcare Toronto, Canada, M5B 1W8 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations CHU de Québec-Université Laval Quebec, Canada, G1R 2J6 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Centre de services ambulatoires de dialyse de Gaspé Montreal, Canada, H2T 3B3 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regionaal ZH Jan Yperman Campus Mariaziekenhuis IEPER, Belgium, 8900 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Antwerpen EDEGEM, Belgium, 2650 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UZ Brussel BRUXELLES - BRUSSEL, Belgium, 1090 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations OL Vrouwziekenhuis - Campus Aalst AALST, Belgium, 9300 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Oblastni nemocnice Mlada Boleslav Mlada Boleslav, Czech Republic, 293 50 | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Nemocnice Frydek-Mistek Frydek-Mistek, Czech Republic, 738 01 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fakultni nemocnice Brno Brno, Czech Republic, 62500 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Nephro Care s.r.o. Praha 9 - Vysocany, Czech Republic, 190 61 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Klatovska nemocnice Klatovy, Czech Republic, 339 38 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Fresenius Medical Care - DS, s.r.o. Melnik, Czech Republic, 276 01 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations “Dialysis center Hemomed” EOOD Sofia, Bulgaria, 1606 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations V MHAT Sofia, Bulgaria, 1233 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Sveta Anna Sofia, Bulgaria, 1872 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT National Cardiology Hospital EAD Sofia, Bulgaria, 1309 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations FIRST DIALYSIS SERVICES BULGARIA EAD Montana, Bulgaria, 3400 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations UMHATEM N. I. Pirogov EAD Sofia, Bulgaria, 1606 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations MHAT Samokov Samokov, Bulgaria, 2000 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bioclinic Thessaloniki Thessaloniki, Greece, 54622 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Patra Patra Rio, Greece, 26504 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations PAPANIKOLAOU General Hospital Thessaloniki Pilea Chortiatis, Greece, 57010 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations University General Hospital of Heraklion Heraklion, Greece, 711 10 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Omsk Regional Clinical Hospital Omsk, Russia, 644111 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Limited Liability Company "Nefroline-Novosibirsk" Novosibirsk, Russia, 630064 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Dialysis center Podolsk, Russia, 142110 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations High Technology Center Clinic 1 Moscow, Russia, 125466 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations LLC Frezenius Nefrocare Penza, Russia, 440034 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Kyiv City Center of Nephrology and Dialysis Kyiv, Ukraine, 01023 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Zaporizhia Municipal Clinical Hospital No.10 Zaporizhzhya, Ukraine, 69001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Regional Clinical Hospital Odessa, Ukraine, 65025 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Medical Center Fresenius Medical Care Ukraine, LLC Chernigiv, Ukraine, 14034 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations P. Stradins Clinical University Hospital Riga, Latvia, LV-1002 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Vidzemes Hospital Valmiera, Latvia, LV-4201 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Liepaja Regional Hospital Liepaja, Latvia, LV-3414 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Daugavpils Regional Hospital Daugavpils, Latvia, LV-5417 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Med Alfa Riga, Latvia, LV-1001 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont Szeged, Hungary, 6720 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Katai Gabor Korhaz Karcag, Hungary, 5300 | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Bacs-Kiskun Megyei Korhaz Kalocsa, Hungary, 6300 | Status Not yet recruiting | 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 major bleeding and clinically relevant non-major bleeding during the main treatment periodTimeframe: Up to 24 weeks
Secondary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs)Timeframe: Up to 24 weeks
- Number of participants with severity of treatment-emergent adverse events (TEAEs)Timeframe: Up to 24 weeks
- Trough concentrations (Ctrough) of three dose levels of BAY2976217Timeframe: At study days 1, 2, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 148, 155, 162 and 169
- Maximum change in FXI antigen levels during the main treatment periodTimeframe: Up to 24 weeks
- Maximum change in FXI activity levels during the main treatment periodTimeframe: Up to 24 weeks
Additional Information
Not Available
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