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End-Stage Renal DiseasePhase 2NCT05027074

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 Phase 2 study testing MK-2060 in people with End-Stage Renal Disease and End-Stage Kidney Disease, run by Merck Sharp & Dohme LLC at 120 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MK-2060
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
506 participants
Where
120 sitesin 15 countries
Study dates
17 Sep 2021to 13 Feb 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Recent history of cancer (<1 year). Non-melanoma skin cancers are allowed.
  • 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.

Trial locations and contacts

120 sites in 15 countries.

120 sites in 15 countries

United States77 sites

  • Capital District Renal Physicians ( Site 0633)

    Albany, New York, 12209

  • Renal Medicine Associates ( Site 0690)

    Albuquerque, New Mexico, 87109

  • DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562)

    Anaheim, California, 92801

  • DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547)

    Bakersfield, California, 93304

  • Fresenius Kidney Care Bakersfield Northeast ( Site 0647)

    Bakersfield, California, 93306

  • Fresenius Kidney Care Meadows Field ( Site 0618)

    Bakersfield, California, 93308

  • Northeast Clinical Research Center ( Site 0653)

    Bethlehem, Pennsylvania, 18017

  • Research Physicians Network Alliance ( Site 0563)

    Boca Raton, Florida, 33431

  • Fresenius Kidney Care Brookhaven ( Site 0693)

    Brookhaven, Mississippi, 39601

  • Fresenius Kidney Care - Charlotte ( Site 0686)

    Charlotte, North Carolina, 28208

  • University of Chicago Medical Center-Medicine - Section of Nephrology ( Site 0595)

    Chicago, Illinois, 60637

  • California Institute Of Renal Research ( Site 0660)

    Chula Vista, California, 91910

  • DaVita Clinical Research - Columbus ( Site 0532)

    Columbus, Georgia, 31904

  • Horizon Research Group ( Site 0578)

    Coral Gables, Florida, 33134

  • Horizon Research Group ( Site 0581)

    Coral Gables, Florida, 33134

  • Citrus Dialysis Center ( Site 0609)

    Covina, California, 91723

  • Renal Disease Research Institute ( Site 0621)

    Dallas, Texas, 75235

  • Henry Ford Hospital-Nephrology and Hypertension ( Site 0694)

    Detroit, Michigan, 48202

  • Durham Nephrology Associates ( Site 0655)

    Durham, North Carolina, 27704

  • California Institute Of Renal Research ( Site 0679)

    El Centro, California, 92243

  • DaVita Clinical Research - El Paso ( Site 0505)

    El Paso, Texas, 79925

  • California Institute of Renal Research ( Site 0566)

    Escondido, California, 92025

  • Elixia at Florida Kidney Physicians - Southeast ( Site 0602)

    Fort Lauderdale, Florida, 33308

  • South Florida Research Institute ( Site 0656)

    Fort Lauderdale, Florida, 33313

  • Fresenius Kidney Care Newhope Fountain Valley ( Site 0617)

    Fountain Valley, California, 92708

  • DaVita Glendale Heights ( Site 0604)

    Glendale, California, 91201

  • DaVita West Glendale Dialysis ( Site 0579)

    Glendale, California, 91205

  • DaVita North Glendale ( Site 0552)

    Glendale, California, 91206

  • Capital Nephrology ( Site 0596)

    Greenbelt, Maryland, 20770

  • East Carolina University-Department of Nephrology & Hypertension ( Site 0663)

    Greenville, North Carolina, 27834

  • DaVita Clinical Research - Hartford ( Site 0507)

    Hartford, Connecticut, 06112

  • Elixia Clinical Research Collaborative (CRC) - Southeast Florida ( Site 0728)

    Hollywood, Florida, 33020

  • Pines Clinical Research ( Site 0605)

    Hollywood, Florida, 33024

  • DaVita Clinical Research - Houston ( Site 0508)

    Houston, Texas, 77004

  • Clinical Research Strategies ( Site 0625)

    Houston, Texas, 77090

  • Southwest Houston Research ( Site 0649)

    Houston, Texas, 77099

  • Nephrology Consultants ( Site 0681)

    Huntsville, Alabama, 35805

  • Clinical Research Consultants, LLC ( Site 0542)

    Kansas City, Missouri, 64111

  • Knoxville Kidney Center ( Site 0689)

    Knoxville, Tennessee, 37923

  • California Institute of Renal Research - La Mesa ( Site 0682)

    La Mesa, California, 91941

  • La Puente Dialysis Center ( Site 0610)

    La Puente, California, 91744

  • DaVita Five Star Dialysis Center ( Site 0509)

    Las Vegas, Nevada, 89128

  • Somnos Clinical Research ( Site 0669)

    Lincoln, Nebraska, 68505

  • Academic Medical Research Institute ( Site 0533)

    Los Angeles, California, 90022

  • DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548)

    Los Angeles, California, 90033

  • DaVita Crescent Heights Dialysis Center ( Site 0574)

    Los Angeles, California, 90048

  • Texas Institute for Kidney and Endocrine Disorders ( Site 0626)

    Lufkin, Texas, 75904

  • North America Research Institute ( Site 0587)

    Lynwood, California, 90262

  • North America Research Institute ( Site 0612)

    Lynwood, California, 90262

  • Renal Physicians of Georgia ( Site 0577)

    Macon, Georgia, 31217

  • Gamma Medical Research ( Site 0688)

    McAllen, Texas, 78503

  • Nephrology Specialists - Merrillville ( Site 0537)

    Merrillville, Indiana, 46410

  • Floridian Clinical Research, LLC ( Site 0684)

    Miami Lakes, Florida, 33016

  • Nephrology Specialists - Michigan City ( Site 0541)

    Michigan City, Indiana, 46360

  • DaVita Clinical Research - Middlebury ( Site 0511)

    Middlebury, Connecticut, 06762

  • DaVita Clinical Research ( Site 0502)

    Minneapolis, Minnesota, 55404

  • DaVita Clinical Research - Norfolk ( Site 0513)

    Norfolk, Virginia, 23502

  • Valley Renal Medical Group Research-Clinical Research ( Site 0651)

    Northridge, California, 91343

  • South Carolina Nephrology & Hypertension Center-Research ( Site 0672)

    Orangeburg, South Carolina, 29118

  • Omega Research Orlando ( Site 0645)

    Orlando, Florida, 32808

  • AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723)

    Phoenix, Arizona, 85035

  • Ridgewood Dialysis Center ( Site 0725)

    Ridgewood, New York, 11385

  • Kidney and Hypertension Center ( Site 0571)

    Roseburg, Oregon, 97471

  • St. Clair Nephrology Research - Roseville ( Site 0597)

    Roseville, Michigan, 48066

  • California Institute of Renal Research - Kearny Mesa ( Site 0678)

    San Diego, California, 92111

  • North America Research Institute ( Site 0611)

    San Dimas, California, 91773

  • DaVita East Georgia Dialysis Unit ( Site 0536)

    Statesboro, Georgia, 30458

  • Genesis Clinical Research, LLC ( Site 0585)

    Tampa, Florida, 33603

  • Genesis Clinical Research, LLC ( Site 0594)

    Tampa, Florida, 33603

  • Genesis Clinical Research, LLC ( Site 0680)

    Tampa, Florida, 33603

  • Albert Einstein College of Medicine-Department of Medicine-Nephrology Einstein ( Site 0628)

    The Bronx, New York, 10461

  • DaVita Clinical Researh ( Site 0501)

    The Bronx, New York, 10461

  • AKDHC Medical Research Services, LLC ( Site 0629)

    Tucson, Arizona, 85741

  • Elixia at Clinical Renal Associates ( Site 0677)

    Upland, Pennsylvania, 19013

  • DaVita Van Nuys Dialysis ( Site 0538)

    Van Nuys, California, 91405

  • Desert Cities Diaylsis-Clinical Research ( Site 0615)

    Victorville, California, 92392

  • DaVita Clinical Research - Milwaukee ( Site 0512)

    Wauwatosa, Wisconsin, 53226

Other trials in United States

Argentina7 sites

  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0010)

    Buenos Aires, Buenos Aires F.D., C1431FWO

  • Fresenius Medical Care Ciudad Evita ( Site 0006)

    Buenos Aires, B1778IFA

  • FME Mansilla ( Site 0007)

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425BPM

  • Fresenius Medical Care - Moron ( Site 0008)

    Morón, Buenos Aires, B1708DPO

  • Fresenius Medical Care - San Fernando ( Site 0013)

    San Fernando, Buenos Aires, 1646

  • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0001)

    Santa Fe, 3000

  • CEREHA ( Site 0004)

    Sarandí, Buenos Aires, B1872JBA

Other trials in Argentina

Bulgaria5 sites

  • Multiprofile Hospital for Active Treatment - "Dr. Cherven Bryag"-Department of dialysis treatment (

    Cherven Bryag, Lovech, 5980

  • MHAT Dobrich-Department for dialysis treatment ( Site 0161)

    Dobrich, 9300

  • First Dialysis Services Bulgaria ( Site 0158)

    Montana, 3400

  • UMBAL Plovdiv AD-Deparment of Hemodialysis ( Site 0162)

    Plovdiv, 4003

  • Hemomed ( Site 0159)

    Sofia, 1618

Other trials in Bulgaria

Portugal5 sites

  • Fresenius Medical Care - NephroCare Amadora ( Site 0851)

    Amadora, Lisbon District, 2700-391

  • Fresenius Medical Care - NephroCare Almada ( Site 0854)

    Corroios, Lisbon District, 2855-227

  • Fresenius Medical Care - NephroCare Covilha ( Site 0852)

    Covilha, Castelo Branco District, 6200-000

  • Dyalisis Center - Clinic NephroCare Lumiar -Fresenius ( Site 0853)

    Lisbon, Lisbon District, 1750-130

  • Fresenius Medical Care - Nephrocare Portimao ( Site 0855)

    Portimão, Faro District, 8500-311

Other trials in Portugal

Romania4 sites

  • Fresenius Nephrocare - Brașov ( Site 0409)

    Brașov, Brăila County, 500152

  • Fresenius Nephrocare - Bucharest ( Site 0408)

    Bucharest, Bucharest, 013217

  • Fresenius Nephrocare - Cluj-Napoca ( Site 0410)

    Cluj-Napoca, Cluj, 400528

  • Fresenius Nephrocare - Iași ( Site 0406)

    Iași, Iaşi, 700523

Other trials in Romania

Brazil3 sites

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site

    São José do Rio Preto, São Paulo, 15090000

  • Fresenius Clinical Trials Perdizes ( Site 0101)

    São Paulo, São Paulo, 05024-030

  • Hospital do Rim e Hipertensão ( Site 0106)

    São Paulo, 04038-002

Other trials in Brazil

Czechia3 sites

  • Dialýza ( Site 0256)

    Beroun, 266 01

  • Fresenius Medical Care ( Site 0253)

    Pardubice, 532 03

  • Fresenius Medical Care - Dialyzační středisko ( Site 0254)

    Prague, Praha 4, 142 00

Other trials in Czechia

Greece3 sites

  • ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Sit

    Chaïdári, Attica, 124 62

  • Ippokrateio General Hospital of Thessaloniki ( Site 1053)

    Thessaloniki, Central Macedonia, 546 42

  • G. Papanikolaou General Hospital-Nephrology Department ( Site 1052)

    Thessaloniki, 570 10

Other trials in Greece

Italy3 sites

  • P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO ( Site 0954)

    Milan, Milano, 20153

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0953)

    Milan, 20162

  • Fondazione Salvatore Maugeri clinica del lavoro ( Site 0955)

    Pavia, 27100

Other trials in Italy

Sweden3 sites

  • Skånes Universitetssjukhus Malmö ( Site 0454)

    Malmö, Skåne County, 205 02

  • Karolinska Universitetssjukhuset Huddinge-ME Njurmedicin ( Site 0451)

    Stockholm, Stockholm County, 141 86

  • Akademiska sjukhuset-Njurmottagningen ( Site 0453)

    Uppsala, Uppsala County, 751 85

Other trials in Sweden

Canada2 sites

  • University Of Alberta Hospital ( Site 1001)

    Edmonton, Alberta, T6G 2B7

  • Toronto General Hospital ( Site 1002)

    Toronto, Ontario, M5G 2C4

Other trials in Canada

Russia2 sites

  • Unipharm LLC ( Site 0804)

    Krasnogorsk, Moscow Oblast, 143403

  • Limited Liability Company -Nefroline-Novosibirsk ( Site 0810)

    Novosibirsk, Novosibirsk Oblast, 630064

Other trials in Russia

Australia1 site

  • Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054)

    St Albans, Victoria, 3021

Other trials in Australia

Germany1 site

  • DaVita Clinical Research Germany GmbH ( Site 0901)

    Düsseldorf, North Rhine-Westphalia, 40210

Other trials in Germany

Puerto Rico1 site

  • Fresenius Medical Care Humacao ( Site 0354)

    Humacao, 00971

Other trials in Puerto Rico

About this study

Official title: 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

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.

Being tested
MK-2060, Placebo
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MK-2060Drug

    MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion

  • PlaceboDrug

    Normal saline administered via IV infusion

Study groups in NCT05027074
Study groupRoleWhat they receive
MK-2060 20 mgExperimentalMK-2060 20 mg administered via IV infusion during dialysis as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
Receives: Drug: MK-2060
MK-2060 6 mgExperimentalMK-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
Receives: Drug: MK-2060
PlaceboPlacebo comparatorPlacebo (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
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to First Arteriovenous Graft (AVG) Thrombosis Event

    An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. A blinded independent clinical adjudication committee (CAC) adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.

    Measured: From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 37 months

Secondary outcomes (4)

  1. Time to Each AVG Thrombosis Event (First and Recurrent)

    An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. A blinded independent CAC adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.

    Measured: Up to approximately 37 months

  2. Number of Participants Who Experience One or More Adverse Events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants with one or more AEs is presented.

    Measured: Up to approximately 40 months

  3. Time to First Event of International Society on Thrombosis (ISTH) Major Bleeding Event or a Clinically Relevant Non-Major Bleeding Event

    Major bleeding events were defined as a having symptomatic presentation and including ≥1 of the following criteria: 1) Fatal bleeding 2) Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, intramuscular with compartment syndrome 3) Bleeding causing decrease in hematocrit level of 20 g/L or more or leading to transfusion of ≥2 units of whole blood or red cells. Clinically relevant non-major bleeding events were defined as signs or symptoms of hemorrhage that do not meet criteria for major bleeding events but meet ≥1 of the following criteria: 1) Requiring medical intervention by healthcare professional 2) Leading to hospitalization or increased level of care 3) Prompting face-to-face evaluation by healthcare professional. A time-to-event methodology was used. The incidence rate is presented.

    Measured: From date of first dose of study intervention until the first ISTH major bleeding event or a clinically relevant non-major bleeding event. assessed up to approximately 40 months

  4. Number of Participants Who Discontinue Study Intervention Due to an AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study intervention due to an AE is presented.

    Measured: Up to approximately 37 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2021
  2. Study start17 Sep 2021
  3. Primary completion30 Oct 2024
  4. Study completion13 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
506 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05027074
Sponsor's protocol ID
2060-007
Other IDs
MK-2060-007, 2024-511055-17-00, U1111-1303-0286, 2020-002397-27
Status last verified
Jan 2026
First submitted
26 Aug 2021
Last updated
11 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MK-2060 in people with End-Stage Renal Disease and End-Stage Kidney Disease, run by Merck Sharp & Dohme LLC at 120 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Argentina, Bulgaria, Portugal, Romania and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to First Arteriovenous Graft (AVG) Thrombosis Event (time frame: From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 37 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05027074.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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