Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)
NCT ID: NCT05027074
Last Updated: 2025-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
506 participants
INTERVENTIONAL
2021-09-17
2025-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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MK-2060 20 mg
MK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
MK-2060
MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion
MK-2060 6 mg
MK-2060 6 mg administered via intravenous (IV) infusion during dialysis as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1
MK-2060
MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion
Placebo
Placebo (normal saline) administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Placebo
Normal saline administered via IV infusion
Interventions
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MK-2060
MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion
Placebo
Normal saline administered via IV infusion
Eligibility Criteria
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Inclusion Criteria
* Receiving hemodialysis (including hemodiafiltration) ≥3 times per week for a minimum of 3 hours per session via a mature normally functioning, uninfected AVG with at least 75% of the sessions meeting these criteria over the 4 weeks prior to randomization.
* A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 90 days after the last dose of study intervention.
Exclusion Criteria
* Mechanical/prosthetic heart valve.
* Recent hemorrhagic stroke or lacunar stroke (\<1 month).
* Recent evidence (\<1 month) of bleeding requiring hospitalization or unplanned medical attention, a history (≤2 years) of recurrent bleeding episodes including epistaxis, gastrointestinal (GI) bleeds or genitourinary (GU) bleeds requiring medical treatment or events requiring treatment with blood products.
* Recent history (\<1 year) of drug or alcohol abuse or dependence.
* Currently receiving or planning to receive anticoagulants or antiplatelet medications (intradialytic heparin and aspirin are permitted).
* Planning on receiving a living donor renal transplant within 12 months (participants are permitted to be candidates for deceased donor renal transplants).
* Planning on receiving an arteriovenous fistula (AVF) placement within 12 months.
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Nephrology Consultants ( Site 0681)
Huntsville, Alabama, United States
AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723)
Phoenix, Arizona, United States
AKDHC Medical Research Services, LLC ( Site 0629)
Tucson, Arizona, United States
DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562)
Anaheim, California, United States
DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547)
Bakersfield, California, United States
Fresenius Kidney Care Bakersfield Northeast ( Site 0647)
Bakersfield, California, United States
Fresenius Kidney Care Meadows Field ( Site 0618)
Bakersfield, California, United States
California Institute Of Renal Research ( Site 0660)
Chula Vista, California, United States
Citrus Dialysis Center ( Site 0609)
Covina, California, United States
California Institute Of Renal Research ( Site 0679)
El Centro, California, United States
California Institute of Renal Research ( Site 0566)
Escondido, California, United States
Fresenius Kidney Care Newhope Fountain Valley ( Site 0617)
Fountain Valley, California, United States
DaVita Glendale Heights ( Site 0604)
Glendale, California, United States
DaVita West Glendale Dialysis ( Site 0579)
Glendale, California, United States
DaVita North Glendale ( Site 0552)
Glendale, California, United States
California Institute of Renal Research - La Mesa ( Site 0682)
La Mesa, California, United States
La Puente Dialysis Center ( Site 0610)
La Puente, California, United States
Academic Medical Research Institute ( Site 0533)
Los Angeles, California, United States
DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548)
Los Angeles, California, United States
DaVita Crescent Heights Dialysis Center ( Site 0574)
Los Angeles, California, United States
North America Research Institute ( Site 0587)
Lynwood, California, United States
North America Research Institute ( Site 0612)
Lynwood, California, United States
Valley Renal Medical Group Research-Clinical Research ( Site 0651)
Northridge, California, United States
California Institute of Renal Research - Kearny Mesa ( Site 0678)
San Diego, California, United States
North America Research Institute ( Site 0611)
San Dimas, California, United States
DaVita Van Nuys Dialysis ( Site 0538)
Van Nuys, California, United States
Desert Cities Diaylsis-Clinical Research ( Site 0615)
Victorville, California, United States
DaVita Clinical Research - Hartford ( Site 0507)
Hartford, Connecticut, United States
DaVita Clinical Research - Middlebury ( Site 0511)
Middlebury, Connecticut, United States
Research Physicians Network Alliance ( Site 0563)
Boca Raton, Florida, United States
Horizon Research Group ( Site 0578)
Coral Gables, Florida, United States
Horizon Research Group ( Site 0581)
Coral Gables, Florida, United States
Elixia at Florida Kidney Physicians - Southeast ( Site 0602)
Fort Lauderdale, Florida, United States
South Florida Research Institute ( Site 0656)
Fort Lauderdale, Florida, United States
Elixia Clinical Research Collaborative (CRC) - Southeast Florida ( Site 0728)
Hollywood, Florida, United States
Pines Clinical Research ( Site 0605)
Hollywood, Florida, United States
Floridian Clinical Research, LLC ( Site 0684)
Miami Lakes, Florida, United States
Omega Research Orlando ( Site 0645)
Orlando, Florida, United States
Genesis Clinical Research, LLC ( Site 0585)
Tampa, Florida, United States
Genesis Clinical Research, LLC ( Site 0594)
Tampa, Florida, United States
Genesis Clinical Research, LLC ( Site 0680)
Tampa, Florida, United States
DaVita Clinical Research - Columbus ( Site 0532)
Columbus, Georgia, United States
Renal Physicians of Georgia ( Site 0577)
Macon, Georgia, United States
DaVita East Georgia Dialysis Unit ( Site 0536)
Statesboro, Georgia, United States
University of Chicago Medical Center-Medicine - Section of Nephrology ( Site 0595)
Chicago, Illinois, United States
Nephrology Specialists - Merrillville ( Site 0537)
Merrillville, Indiana, United States
Nephrology Specialists - Michigan City ( Site 0541)
Michigan City, Indiana, United States
Capital Nephrology ( Site 0596)
Greenbelt, Maryland, United States
Henry Ford Hospital-Nephrology and Hypertension ( Site 0694)
Detroit, Michigan, United States
St. Clair Nephrology Research - Roseville ( Site 0597)
Roseville, Michigan, United States
DaVita Clinical Research ( Site 0502)
Minneapolis, Minnesota, United States
Fresenius Kidney Care Brookhaven ( Site 0693)
Brookhaven, Mississippi, United States
Clinical Research Consultants, LLC ( Site 0542)
Kansas City, Missouri, United States
Somnos Clinical Research ( Site 0669)
Lincoln, Nebraska, United States
DaVita Five Star Dialysis Center ( Site 0509)
Las Vegas, Nevada, United States
Renal Medicine Associates ( Site 0690)
Albuquerque, New Mexico, United States
Capital District Renal Physicians ( Site 0633)
Albany, New York, United States
Ridgewood Dialysis Center ( Site 0725)
Ridgewood, New York, United States
Albert Einstein College of Medicine-Department of Medicine-Nephrology Einstein ( Site 0628)
The Bronx, New York, United States
DaVita Clinical Researh ( Site 0501)
The Bronx, New York, United States
Fresenius Kidney Care - Charlotte ( Site 0686)
Charlotte, North Carolina, United States
Durham Nephrology Associates ( Site 0655)
Durham, North Carolina, United States
East Carolina University-Department of Nephrology & Hypertension ( Site 0663)
Greenville, North Carolina, United States
Kidney and Hypertension Center ( Site 0571)
Roseburg, Oregon, United States
Northeast Clinical Research Center ( Site 0653)
Bethlehem, Pennsylvania, United States
Elixia at Clinical Renal Associates ( Site 0677)
Upland, Pennsylvania, United States
South Carolina Nephrology & Hypertension Center-Research ( Site 0672)
Orangeburg, South Carolina, United States
Knoxville Kidney Center ( Site 0689)
Knoxville, Tennessee, United States
Renal Disease Research Institute ( Site 0621)
Dallas, Texas, United States
DaVita Clinical Research - El Paso ( Site 0505)
El Paso, Texas, United States
DaVita Clinical Research - Houston ( Site 0508)
Houston, Texas, United States
Clinical Research Strategies ( Site 0625)
Houston, Texas, United States
Southwest Houston Research ( Site 0649)
Houston, Texas, United States
Texas Institute for Kidney and Endocrine Disorders ( Site 0626)
Lufkin, Texas, United States
Gamma Medical Research ( Site 0688)
McAllen, Texas, United States
DaVita Clinical Research - Norfolk ( Site 0513)
Norfolk, Virginia, United States
DaVita Clinical Research - Milwaukee ( Site 0512)
Wauwatosa, Wisconsin, United States
FME Mansilla ( Site 0007)
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Fresenius Medical Care - Moron ( Site 0008)
Morón, Buenos Aires, Argentina
Fresenius Medical Care - San Fernando ( Site 0013)
San Fernando, Buenos Aires, Argentina
CEREHA ( Site 0004)
Sarandí, Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0010)
Buenos Aires, Buenos Aires F.D., Argentina
Fresenius Medical Care Ciudad Evita ( Site 0006)
Buenos Aires, , Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0001)
Santa Fe, , Argentina
Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054)
St Albans, Victoria, Australia
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
São José do Rio Preto, São Paulo, Brazil
Fresenius Clinical Trials Perdizes ( Site 0101)
São Paulo, São Paulo, Brazil
Hospital do Rim e Hipertensão ( Site 0106)
São Paulo, , Brazil
Multiprofile Hospital for Active Treatment - "Dr. Cherven Bryag"-Department of dialysis treatment (
Cherven Bryag, Lovech, Bulgaria
MHAT Dobrich-Department for dialysis treatment ( Site 0161)
Dobrich, , Bulgaria
First Dialysis Services Bulgaria ( Site 0158)
Montana, , Bulgaria
UMBAL Plovdiv AD-Deparment of Hemodialysis ( Site 0162)
Plovdiv, , Bulgaria
Hemomed ( Site 0159)
Sofia, , Bulgaria
University Of Alberta Hospital ( Site 1001)
Edmonton, Alberta, Canada
Toronto General Hospital ( Site 1002)
Toronto, Ontario, Canada
Fresenius Medical Care - Dialyzační středisko ( Site 0254)
Prague, Praha 4, Czechia
Dialýza ( Site 0256)
Beroun, , Czechia
Fresenius Medical Care ( Site 0253)
Pardubice, , Czechia
DaVita Clinical Research Germany GmbH ( Site 0901)
Düsseldorf, North Rhine-Westphalia, Germany
ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Sit
Chaïdári, Attica, Greece
Ippokrateio General Hospital of Thessaloniki ( Site 1053)
Thessaloniki, Central Macedonia, Greece
G. Papanikolaou General Hospital-Nephrology Department ( Site 1052)
Thessaloniki, , Greece
P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO ( Site 0954)
Milan, Milano, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 0953)
Milan, , Italy
Fondazione Salvatore Maugeri clinica del lavoro ( Site 0955)
Pavia, , Italy
Fresenius Medical Care - NephroCare Covilha ( Site 0852)
Covilha, Castelo Branco District, Portugal
Fresenius Medical Care - Nephrocare Portimao ( Site 0855)
Portimão, Faro District, Portugal
Fresenius Medical Care - NephroCare Amadora ( Site 0851)
Amadora, Lisbon District, Portugal
Fresenius Medical Care - NephroCare Almada ( Site 0854)
Corroios, Lisbon District, Portugal
Dyalisis Center - Clinic NephroCare Lumiar -Fresenius ( Site 0853)
Lisbon, Lisbon District, Portugal
Fresenius Medical Care Humacao ( Site 0354)
Humacao, , Puerto Rico
Fresenius Nephrocare - Brașov ( Site 0409)
Brașov, Brăila County, Romania
Fresenius Nephrocare - Bucharest ( Site 0408)
Bucharest, București, Romania
Fresenius Nephrocare - Cluj-Napoca ( Site 0410)
Cluj-Napoca, Cluj, Romania
Fresenius Nephrocare - Iași ( Site 0406)
Iași, Iaşi, Romania
Unipharm LLC ( Site 0804)
Krasnogorsk, Moscow Oblast, Russia
Limited Liability Company -Nefroline-Novosibirsk ( Site 0810)
Novosibirsk, Novosibirsk Oblast, Russia
Skånes Universitetssjukhus Malmö ( Site 0454)
Malmo, Skåne County, Sweden
Karolinska Universitetssjukhuset Huddinge-ME Njurmedicin ( Site 0451)
Stockholm, Stockholm County, Sweden
Akademiska sjukhuset-Njurmottagningen ( Site 0453)
Uppsala, Uppsala County, Sweden
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2060-007
Identifier Type: -
Identifier Source: org_study_id
MK-2060-007
Identifier Type: OTHER
Identifier Source: secondary_id
2024-511055-17-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1303-0286
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-002397-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
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