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

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

Sponsors

Lead Sponsor: Bayer

Source Bayer
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.

Overall Status Recruiting
Start Date September 4, 2020
Completion Date September 29, 2022
Primary Completion Date May 23, 2022
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of major bleeding and clinically relevant non-major bleeding during the main treatment period Up to 24 weeks
Secondary Outcome
Measure Time Frame
Number of participants with treatment-emergent adverse events (TEAEs) Up to 24 weeks
Number of participants with severity of treatment-emergent adverse events (TEAEs) Up to 24 weeks
Trough concentrations (Ctrough) of three dose levels of BAY2976217 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 period Up to 24 weeks
Maximum change in FXI activity levels during the main treatment period Up to 24 weeks
Enrollment 288
Condition
Intervention

Intervention Type: Drug

Intervention Name: BAY2976217

Description: Study intervention will be injected subcutaneously.

Other Name: Factor XI LICA

Intervention Type: Drug

Intervention Name: Placebo

Description: Matching placebo to BAY2976217 will be injected subcutaneously.

Arm Group Label: Pooled Placebo

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 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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Bayer Clinical Trials Contact

Phone: (+)1-888-84 22937

Email: [email protected]

Location
Facility: Status:
Fresenius Kidney Care Clovis | Clovis, California, 93611, United States Not yet recruiting
Desert Cities Dialysis-Amethyst & Desert Cities Dialysis | Victorville, California, 92392, United States Not yet recruiting
Davita East Ft. Lauderdale Dialysis Center | Fort Lauderdale, Florida, 33316, United States Not yet recruiting
DaVita Orlando North Dialysis | Orlando, Florida, 32804, United States Not yet recruiting
Fresenius Medical Care Tampa North | Temple Terrace, Florida, 33637, United States Not yet recruiting
DaVita Minneapolis Diaysis Unit | Minneapolis, Minnesota, 55404, United States Not yet recruiting
Fresenius Kidney Care St. Louis Regional Dialysis | Saint Ann, Missouri, 63074, United States Not yet recruiting
Chromalloy Dialysis Center | Saint Louis, Missouri, 63110, United States Not yet recruiting
Fresenius Medical Care - Fire Mesa Dialysis Unit | Las Vegas, Nevada, 89128, United States Not yet recruiting
Elixia At Clinical Renal Associates | Upland, Pennsylvania, 19013, United States Not yet recruiting
DaVita Med Center Dialysis | Houston, Texas, 77004, United States Not yet recruiting
DaVita Northwest Medical Center Dialysis | San Antonio, Texas, 78229, United States Not yet recruiting
San Antonio Kidney Disease Center Physicians Group, PLLC | San Antonio, Texas, 78258, United States Not yet recruiting
OL Vrouwziekenhuis - Campus Aalst | Aalst, 9300, Belgium Not yet recruiting
UZ Brussel | Bruxelles - Brussel, 1090, Belgium Not yet recruiting
UZ Antwerpen | Edegem, 2650, Belgium Recruiting
Regionaal ZH Jan Yperman Campus Mariaziekenhuis | Ieper, 8900, Belgium Not yet recruiting
First Dialysis Services Bulgaria Ead | Montana, 3400, Bulgaria Not yet recruiting
MHAT Samokov | Samokov, 2000, Bulgaria Not yet recruiting
V MHAT | Sofia, 1233, Bulgaria Not yet recruiting
MHAT National Cardiology Hospital EAD | Sofia, 1309, Bulgaria Not yet recruiting
"Dialysis center Hemomed" EOOD | Sofia, 1606, Bulgaria Not yet recruiting
UMHATEM N. I. Pirogov EAD | Sofia, 1606, Bulgaria Not yet recruiting
MHAT Sveta Anna | Sofia, 1872, Bulgaria Not yet recruiting
Etobicoke General Hospital | Etobicoke, Ontario, M9V 1R8, Canada Not yet recruiting
St. Joseph's Healthcare - Hamilton | Hamilton, Ontario, L8N 4A6, Canada Not yet recruiting
Lakeridge Health-Oshawa | Oshawa, Ontario, L1G 2B9, Canada Not yet recruiting
Humber River Hospital | Toronto, Ontario, M3M 0B2, Canada Not yet recruiting
St. Michael's Healthcare | Toronto, Ontario, M5B 1W8, Canada Not yet recruiting
Hopital Charles LeMoyne | Greenfield Park, Quebec, J4V 2H1, Canada Not yet recruiting
Centre de services ambulatoires de dialyse de Gaspé | Montreal, Quebec, H2T 3B3, Canada Not yet recruiting
CHU de Québec-Université Laval | Quebec, G1R 2J6, Canada Not yet recruiting
Fakultni nemocnice Brno | Brno, 62500, Czechia Not yet recruiting
Nemocnice Frydek-Mistek | Frydek-Mistek, 738 01, Czechia Not yet recruiting
Klatovska nemocnice | Klatovy, 339 38, Czechia Not yet recruiting
Fresenius Medical Care - DS, s.r.o. | Melnik, 276 01, Czechia Not yet recruiting
Oblastni nemocnice Mlada Boleslav | Mlada Boleslav, 293 50, Czechia Recruiting
Fresenius Nephro Care s.r.o. | Praha 9 - Vysocany, 190 61, Czechia Not yet recruiting
Robert-Bosch-Krankenhaus | Stuttgart, Baden-Württemberg, 70376, Germany Not yet recruiting
DaVita Clinical Research Deutschland GmbH | Düsseldorf, Nordrhein-Westfalen, 40210, Germany Recruiting
Nephrologisches Zentrum Hoyerswerda | Hoyerswerda, Sachsen, 02977, Germany Not yet recruiting
Universitätsklinikum Schleswig-Holstein (UKSH) | Kiel, Schleswig-Holstein, 24105, Germany Not yet recruiting
University General Hospital of Heraklion | Heraklion, 711 10, Greece Not yet recruiting
University General Hospital of Patra | Patra Rio, 26504, Greece Not yet recruiting
PAPANIKOLAOU General Hospital Thessaloniki | Pilea Chortiatis, 57010, Greece Not yet recruiting
Bioclinic Thessaloniki | Thessaloniki, 54622, Greece Not yet recruiting
Bacs-Kiskun Megyei Korhaz | Kalocsa, 6300, Hungary Not yet recruiting
Katai Gabor Korhaz | Karcag, 5300, Hungary Not yet recruiting
SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont | Szeged, 6720, Hungary Not yet recruiting
Daugavpils Regional Hospital | Daugavpils, LV-5417, Latvia Not yet recruiting
Liepaja Regional Hospital | Liepaja, LV-3414, Latvia Not yet recruiting
Med Alfa | Riga, LV-1001, Latvia Not yet recruiting
P. Stradins Clinical University Hospital | Riga, LV-1002, Latvia Not yet recruiting
Vidzemes Hospital | Valmiera, LV-4201, Latvia Not yet recruiting
High Technology Center Clinic 1 | Moscow, 125466, Russian Federation Not yet recruiting
Limited Liability Company "Nefroline-Novosibirsk" | Novosibirsk, 630064, Russian Federation Not yet recruiting
Omsk Regional Clinical Hospital | Omsk, 644111, Russian Federation Not yet recruiting
LLC Frezenius Nefrocare | Penza, 440034, Russian Federation Not yet recruiting
LLC Dialysis center | Podolsk, 142110, Russian Federation Not yet recruiting
Ciutat Sanitària i Universitària de Bellvitge | L'Hospitalet de Llobregat, Barcelona, 08907, Spain Not yet recruiting
Hospital Sant Joan Despi Moises Broggi | Sant Joan Despi, Barcelona, 08970, Spain Not yet recruiting
Hospital Principe de Asturias | Alcalá de Henares, Madrid, 28805, Spain Not yet recruiting
Hospital de Torrecárdenas | Almería, 04009, Spain Withdrawn
Hospital Clínic i Provincial de Barcelona | Barcelona, 08036, Spain Not yet recruiting
Hospital Universitario Virgen de las Nieves | Granada, 18014, Spain Not yet recruiting
Hospital General Universitario Gregorio Marañón | Madrid, 28007, Spain Not yet recruiting
Complejo Hospitalario de Navarra | Pamplona, 31008, Spain Not yet recruiting
Hospital Universitari i Politècnic La Fe | Valencia, 46026, Spain Not yet recruiting
Medical Center Fresenius Medical Care Ukraine, LLC | Chernigiv, 14034, Ukraine Not yet recruiting
Kyiv City Center of Nephrology and Dialysis | Kyiv, 01023, Ukraine Not yet recruiting
Regional Clinical Hospital | Odessa, 65025, Ukraine Not yet recruiting
Zaporizhia Municipal Clinical Hospital No.10 | Zaporizhzhya, 69001, Ukraine Not yet recruiting
Location Countries

Belgium

Bulgaria

Canada

Czechia

Germany

Greece

Hungary

Latvia

Russian Federation

Spain

Ukraine

United States

Verification Date

October 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: Pooled Placebo

Type: Placebo Comparator

Description: Participants will be allocated at randomization to 1 of 3 dose cohorts 40 mg, 80 mg and 120 mg and within each cohort to receive subcutaneous treatment with either BAY2976217 or matching placebo.

Label: 40 mg BAY2976217

Type: Experimental

Description: Participants will be allocated at randomization to 1 of 3 dose cohorts 40 mg, 80 mg and 120 mg and within each cohort to receive subcutaneous treatment with either BAY2976217 or matching placebo.

Label: 80 mg BAY2976217

Type: Experimental

Description: Participants will be allocated at randomization to 1 of 3 dose cohorts 40 mg, 80 mg and 120 mg and within each cohort to receive subcutaneous treatment with either BAY2976217 or matching placebo.

Label: 120 mg BAY2976217

Type: Experimental

Description: Participants will be allocated at randomization to 1 of 3 dose cohorts 40 mg, 80 mg and 120 mg and within each cohort to receive subcutaneous treatment with either BAY2976217 or matching placebo.

Acronym RE-THINc ESRD
Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov