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NCT05027074CompletedPhase 2

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)

A Randomized Parallel-group, Placebo-controlled, Double-blind, Event-driven, Multi-center Phase 2 Clinical Outcome Trial of Prevention of Arteriovenous Graft Thrombosis and Safety of MK-2060 in Patients With End Stage Renal Disease Receiving Hemodialysis

Source: ClinicalTrials.gov · Last updated 11 Feb 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an arteriovenous graft (AVG). Data from this study will be used to aid dose selection of MK-2060 in future studies. The primary hypothesis is that at least one of the MK-2060 doses is superior to placebo in increasing the time to first occurrence of AVG event.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
506 (actual)
First submitted
26 Aug 2021
Start date
Sept 2021
Primary completion date
Oct 2024
Lead sponsor
Merck Sharp & Dohme LLC
NCT number
NCT05027074
EU CT number
2024-511055-17-00
EudraCT number
2020-002397-27

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 506
  • From Sept 2021 to the primary completion date, Oct 2024
  • 120 sites in 15 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Recent history of cancer (\<1 year). Non-melanoma skin cancers are allowed.
  • Mechanical/prosthetic heart valve.
  • Recent hemorrhagic stroke or lacunar stroke (\<1 month).

Who the study is looking for

  • Current diagnosis of ESRD.
  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (120)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0010)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Fresenius Medical Care Ciudad Evita ( Site 0006)
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
FME Mansilla ( Site 0007)
Coordinator of this site? Confirm its status
Ciudad Autonoma de Buenos AiresArgentinaUnknown status
Fresenius Medical Care - Moron ( Site 0008)
Coordinator of this site? Confirm its status
MorónArgentinaUnknown status
Fresenius Medical Care - San Fernando ( Site 0013)
Coordinator of this site? Confirm its status
San FernandoArgentinaUnknown status
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0001)
Coordinator of this site? Confirm its status
Santa FeArgentinaUnknown status
CEREHA ( Site 0004)
Coordinator of this site? Confirm its status
SarandíArgentinaUnknown status
Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054)
Coordinator of this site? Confirm its status
St AlbansAustraliaUnknown status
Multiprofile Hospital for Active Treatment - "Dr. Cherven Bryag"-Department of dialysis treatment (
Coordinator of this site? Confirm its status
Cherven BryagBulgariaUnknown status
MHAT Dobrich-Department for dialysis treatment ( Site 0161)
Coordinator of this site? Confirm its status
DobrichBulgariaUnknown status
First Dialysis Services Bulgaria ( Site 0158)
Coordinator of this site? Confirm its status
MontanaBulgariaUnknown status
UMBAL Plovdiv AD-Deparment of Hemodialysis ( Site 0162)
Coordinator of this site? Confirm its status
PlovdivBulgariaUnknown status
Hemomed ( Site 0159)
Coordinator of this site? Confirm its status
SofiaBulgariaUnknown status
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
Coordinator of this site? Confirm its status
São José do Rio PretoBrazilUnknown status
Hospital do Rim e Hipertensão ( Site 0106)
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Fresenius Clinical Trials Perdizes ( Site 0101)
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São PauloBrazilUnknown status
University Of Alberta Hospital ( Site 1001)
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EdmontonCanadaUnknown status
Toronto General Hospital ( Site 1002)
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TorontoCanadaUnknown status
Dialýza ( Site 0256)
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BerounCzechiaUnknown status
Fresenius Medical Care ( Site 0253)
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PardubiceCzechiaUnknown status
Fresenius Medical Care - Dialyzační středisko ( Site 0254)
Coordinator of this site? Confirm its status
PragueCzechiaUnknown status
DaVita Clinical Research Germany GmbH ( Site 0901)
Coordinator of this site? Confirm its status
DüsseldorfGermanyUnknown status
ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Sit
Coordinator of this site? Confirm its status
ChaïdáriGreeceUnknown status
G. Papanikolaou General Hospital-Nephrology Department ( Site 1052)
Coordinator of this site? Confirm its status
ThessalonikiGreeceUnknown status
Ippokrateio General Hospital of Thessaloniki ( Site 1053)
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ThessalonikiGreeceUnknown status
P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO ( Site 0954)
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MilanItalyUnknown status
ASST Grande Ospedale Metropolitano Niguarda ( Site 0953)
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MilanItalyUnknown status
Fondazione Salvatore Maugeri clinica del lavoro ( Site 0955)
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PaviaItalyUnknown status
Fresenius Medical Care Humacao ( Site 0354)
Coordinator of this site? Confirm its status
HumacaoPuerto RicoUnknown status
Fresenius Medical Care - NephroCare Amadora ( Site 0851)
Coordinator of this site? Confirm its status
AmadoraPortugalUnknown status
Fresenius Medical Care - NephroCare Almada ( Site 0854)
Coordinator of this site? Confirm its status
CorroiosPortugalUnknown status
Fresenius Medical Care - NephroCare Covilha ( Site 0852)
Coordinator of this site? Confirm its status
CovilhaPortugalUnknown status
Dyalisis Center - Clinic NephroCare Lumiar -Fresenius ( Site 0853)
Coordinator of this site? Confirm its status
LisbonPortugalUnknown status
Fresenius Medical Care - Nephrocare Portimao ( Site 0855)
Coordinator of this site? Confirm its status
PortimãoPortugalUnknown status
Fresenius Nephrocare - Brașov ( Site 0409)
Coordinator of this site? Confirm its status
BrașovRomaniaUnknown status
Fresenius Nephrocare - Bucharest ( Site 0408)
Coordinator of this site? Confirm its status
BucharestRomaniaUnknown status
Fresenius Nephrocare - Cluj-Napoca ( Site 0410)
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Cluj-NapocaRomaniaUnknown status
Fresenius Nephrocare - Iași ( Site 0406)
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IașiRomaniaUnknown status
Unipharm LLC ( Site 0804)
Coordinator of this site? Confirm its status
KrasnogorskRussiaUnknown status
Limited Liability Company -Nefroline-Novosibirsk ( Site 0810)
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NovosibirskRussiaUnknown status
Skånes Universitetssjukhus Malmö ( Site 0454)
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MalmöSwedenUnknown status
Karolinska Universitetssjukhuset Huddinge-ME Njurmedicin ( Site 0451)
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Akademiska sjukhuset-Njurmottagningen ( Site 0453)
Coordinator of this site? Confirm its status
UppsalaSwedenUnknown status
Capital District Renal Physicians ( Site 0633)
Coordinator of this site? Confirm its status
AlbanyUnited StatesUnknown status
Renal Medicine Associates ( Site 0690)
Coordinator of this site? Confirm its status
AlbuquerqueUnited StatesUnknown status
DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562)
Coordinator of this site? Confirm its status
AnaheimUnited StatesUnknown status
Fresenius Kidney Care Bakersfield Northeast ( Site 0647)
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BakersfieldUnited StatesUnknown status
Fresenius Kidney Care Meadows Field ( Site 0618)
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BakersfieldUnited StatesUnknown status
DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547)
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BakersfieldUnited StatesUnknown status
Northeast Clinical Research Center ( Site 0653)
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BethlehemUnited StatesUnknown status
Research Physicians Network Alliance ( Site 0563)
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Boca RatonUnited StatesUnknown status
Fresenius Kidney Care Brookhaven ( Site 0693)
Coordinator of this site? Confirm its status
BrookhavenUnited StatesUnknown status
Fresenius Kidney Care - Charlotte ( Site 0686)
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
University of Chicago Medical Center-Medicine - Section of Nephrology ( Site 0595)
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
California Institute Of Renal Research ( Site 0660)
Coordinator of this site? Confirm its status
Chula VistaUnited StatesUnknown status
DaVita Clinical Research - Columbus ( Site 0532)
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ColumbusUnited StatesUnknown status
Horizon Research Group ( Site 0578)
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Coral GablesUnited StatesUnknown status
Horizon Research Group ( Site 0581)
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Coral GablesUnited StatesUnknown status
Citrus Dialysis Center ( Site 0609)
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CovinaUnited StatesUnknown status
Renal Disease Research Institute ( Site 0621)
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status
Henry Ford Hospital-Nephrology and Hypertension ( Site 0694)
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
Durham Nephrology Associates ( Site 0655)
Coordinator of this site? Confirm its status
DurhamUnited StatesUnknown status
California Institute Of Renal Research ( Site 0679)
Coordinator of this site? Confirm its status
El CentroUnited StatesUnknown status
DaVita Clinical Research - El Paso ( Site 0505)
Coordinator of this site? Confirm its status
El PasoUnited StatesUnknown status
California Institute of Renal Research ( Site 0566)
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EscondidoUnited StatesUnknown status
Elixia at Florida Kidney Physicians - Southeast ( Site 0602)
Coordinator of this site? Confirm its status
Fort LauderdaleUnited StatesUnknown status
South Florida Research Institute ( Site 0656)
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Fort LauderdaleUnited StatesUnknown status
Fresenius Kidney Care Newhope Fountain Valley ( Site 0617)
Coordinator of this site? Confirm its status
Fountain ValleyUnited StatesUnknown status
DaVita North Glendale ( Site 0552)
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GlendaleUnited StatesUnknown status
DaVita Glendale Heights ( Site 0604)
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GlendaleUnited StatesUnknown status
DaVita West Glendale Dialysis ( Site 0579)
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GlendaleUnited StatesUnknown status
Capital Nephrology ( Site 0596)
Coordinator of this site? Confirm its status
GreenbeltUnited StatesUnknown status
East Carolina University-Department of Nephrology & Hypertension ( Site 0663)
Coordinator of this site? Confirm its status
GreenvilleUnited StatesUnknown status
DaVita Clinical Research - Hartford ( Site 0507)
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HartfordUnited StatesUnknown status
Pines Clinical Research ( Site 0605)
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HollywoodUnited StatesUnknown status
Elixia Clinical Research Collaborative (CRC) - Southeast Florida ( Site 0728)
Coordinator of this site? Confirm its status
HollywoodUnited StatesUnknown status
DaVita Clinical Research - Houston ( Site 0508)
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HoustonUnited StatesUnknown status
Clinical Research Strategies ( Site 0625)
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Southwest Houston Research ( Site 0649)
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HoustonUnited StatesUnknown status
Nephrology Consultants ( Site 0681)
Coordinator of this site? Confirm its status
HuntsvilleUnited StatesUnknown status
Clinical Research Consultants, LLC ( Site 0542)
Coordinator of this site? Confirm its status
Kansas CityUnited StatesUnknown status
Knoxville Kidney Center ( Site 0689)
Coordinator of this site? Confirm its status
KnoxvilleUnited StatesUnknown status
California Institute of Renal Research - La Mesa ( Site 0682)
Coordinator of this site? Confirm its status
La MesaUnited StatesUnknown status
La Puente Dialysis Center ( Site 0610)
Coordinator of this site? Confirm its status
La PuenteUnited StatesUnknown status
DaVita Five Star Dialysis Center ( Site 0509)
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Las VegasUnited StatesUnknown status
Somnos Clinical Research ( Site 0669)
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LincolnUnited StatesUnknown status
DaVita Crescent Heights Dialysis Center ( Site 0574)
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Los AngelesUnited StatesUnknown status
Academic Medical Research Institute ( Site 0533)
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Los AngelesUnited StatesUnknown status
DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548)
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Texas Institute for Kidney and Endocrine Disorders ( Site 0626)
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LufkinUnited StatesUnknown status
North America Research Institute ( Site 0587)
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LynwoodUnited StatesUnknown status
North America Research Institute ( Site 0612)
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LynwoodUnited StatesUnknown status
Renal Physicians of Georgia ( Site 0577)
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MaconUnited StatesUnknown status
Gamma Medical Research ( Site 0688)
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McAllenUnited StatesUnknown status
Nephrology Specialists - Merrillville ( Site 0537)
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MerrillvilleUnited StatesUnknown status
Floridian Clinical Research, LLC ( Site 0684)
Coordinator of this site? Confirm its status
Miami LakesUnited StatesUnknown status
Nephrology Specialists - Michigan City ( Site 0541)
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Michigan CityUnited StatesUnknown status
DaVita Clinical Research - Middlebury ( Site 0511)
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MiddleburyUnited StatesUnknown status
DaVita Clinical Research ( Site 0502)
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MinneapolisUnited StatesUnknown status
DaVita Clinical Research - Norfolk ( Site 0513)
Coordinator of this site? Confirm its status
NorfolkUnited StatesUnknown status
Valley Renal Medical Group Research-Clinical Research ( Site 0651)
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NorthridgeUnited StatesUnknown status
South Carolina Nephrology & Hypertension Center-Research ( Site 0672)
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OrangeburgUnited StatesUnknown status
Omega Research Orlando ( Site 0645)
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OrlandoUnited StatesUnknown status
AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723)
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Ridgewood Dialysis Center ( Site 0725)
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RidgewoodUnited StatesUnknown status
Kidney and Hypertension Center ( Site 0571)
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RoseburgUnited StatesUnknown status
St. Clair Nephrology Research - Roseville ( Site 0597)
Coordinator of this site? Confirm its status
RosevilleUnited StatesUnknown status
California Institute of Renal Research - Kearny Mesa ( Site 0678)
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San DiegoUnited StatesUnknown status
North America Research Institute ( Site 0611)
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San DimasUnited StatesUnknown status
DaVita East Georgia Dialysis Unit ( Site 0536)
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StatesboroUnited StatesUnknown status
Genesis Clinical Research, LLC ( Site 0594)
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TampaUnited StatesUnknown status
Genesis Clinical Research, LLC ( Site 0585)
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TampaUnited StatesUnknown status
Genesis Clinical Research, LLC ( Site 0680)
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TampaUnited StatesUnknown status
Albert Einstein College of Medicine-Department of Medicine-Nephrology Einstein ( Site 0628)
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The BronxUnited StatesUnknown status
DaVita Clinical Researh ( Site 0501)
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The BronxUnited StatesUnknown status
AKDHC Medical Research Services, LLC ( Site 0629)
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TucsonUnited StatesUnknown status
Elixia at Clinical Renal Associates ( Site 0677)
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UplandUnited StatesUnknown status
DaVita Van Nuys Dialysis ( Site 0538)
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Van NuysUnited StatesUnknown status
Desert Cities Diaylsis-Clinical Research ( Site 0615)
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VictorvilleUnited StatesUnknown status
DaVita Clinical Research - Milwaukee ( Site 0512)
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WauwatosaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.