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)

NCT05027074 | Completed Phase 2 Results DMC FDA Drug

• 5 other identifiers: 2060-007MK-2060-0072024-511055-17-00U1111-1303-02862020-002397-27
• Study Type: interventional
• Target: 506
• Locations: 15 countries
• Sites: 120

Brief 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). 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.

Conditions

End-Stage Renal Disease; End-Stage Kidney Disease; Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Time to Each AVG Thrombosis Event (First and Recurrent)

  Up to approximately 37 months

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

  Up to approximately 40 months

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

  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

• Number of Participants Who Discontinue Study Intervention Due to an AE

  Up to approximately 37 months

Study Arms (3)

MK-2060 20 mg

EXPERIMENTAL

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

Drug: MK-2060

MK-2060 6 mg

EXPERIMENTAL

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

Drug: MK-2060

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MK-2060 DRUG

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

MK-2060 20 mg; MK-2060 6 mg

Placebo DRUG

Normal saline administered via IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (120)

Nephrology Consultants ( Site 0681)

Huntsville, Alabama, 35805, United States

Location

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

Phoenix, Arizona, 85035, United States

Location

AKDHC Medical Research Services, LLC ( Site 0629)

Tucson, Arizona, 85741, United States

Location

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

Anaheim, California, 92801, United States

Location

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

Bakersfield, California, 93304, United States

Location

Fresenius Kidney Care Bakersfield Northeast ( Site 0647)

Bakersfield, California, 93306, United States

Location

Fresenius Kidney Care Meadows Field ( Site 0618)

Bakersfield, California, 93308, United States

Location

California Institute Of Renal Research ( Site 0660)

Chula Vista, California, 91910, United States

Location

Citrus Dialysis Center ( Site 0609)

Covina, California, 91723, United States

Location

California Institute Of Renal Research ( Site 0679)

El Centro, California, 92243, United States

Location

California Institute of Renal Research ( Site 0566)

Escondido, California, 92025, United States

Location

Fresenius Kidney Care Newhope Fountain Valley ( Site 0617)

Fountain Valley, California, 92708, United States

Location

DaVita Glendale Heights ( Site 0604)

Glendale, California, 91201, United States

Location

DaVita West Glendale Dialysis ( Site 0579)

Glendale, California, 91205, United States

Location

DaVita North Glendale ( Site 0552)

Glendale, California, 91206, United States

Location

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

La Mesa, California, 91941, United States

Location

La Puente Dialysis Center ( Site 0610)

La Puente, California, 91744, United States

Location

Academic Medical Research Institute ( Site 0533)

Los Angeles, California, 90022, United States

Location

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

Los Angeles, California, 90033, United States

Location

DaVita Crescent Heights Dialysis Center ( Site 0574)

Los Angeles, California, 90048, United States

Location

North America Research Institute ( Site 0587)

Lynwood, California, 90262, United States

Location

North America Research Institute ( Site 0612)

Lynwood, California, 90262, United States

Location

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

Northridge, California, 91343, United States

Location

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

San Diego, California, 92111, United States

Location

North America Research Institute ( Site 0611)

San Dimas, California, 91773, United States

Location

DaVita Van Nuys Dialysis ( Site 0538)

Van Nuys, California, 91405, United States

Location

Desert Cities Diaylsis-Clinical Research ( Site 0615)

Victorville, California, 92392, United States

Location

DaVita Clinical Research - Hartford ( Site 0507)

Hartford, Connecticut, 06112, United States

Location

DaVita Clinical Research - Middlebury ( Site 0511)

Middlebury, Connecticut, 06762, United States

Location

Research Physicians Network Alliance ( Site 0563)

Boca Raton, Florida, 33431, United States

Location

Horizon Research Group ( Site 0578)

Coral Gables, Florida, 33134, United States

Location

Horizon Research Group ( Site 0581)

Coral Gables, Florida, 33134, United States

Location

Elixia at Florida Kidney Physicians - Southeast ( Site 0602)

Fort Lauderdale, Florida, 33308, United States

Location

South Florida Research Institute ( Site 0656)

Fort Lauderdale, Florida, 33313, United States

Location

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

Hollywood, Florida, 33020, United States

Location

Pines Clinical Research ( Site 0605)

Hollywood, Florida, 33024, United States

Location

Floridian Clinical Research, LLC ( Site 0684)

Miami Lakes, Florida, 33016, United States

Location

Omega Research Orlando ( Site 0645)

Orlando, Florida, 32808, United States

Location

Genesis Clinical Research, LLC ( Site 0585)

Tampa, Florida, 33603, United States

Location

Genesis Clinical Research, LLC ( Site 0594)

Tampa, Florida, 33603, United States

Location

Genesis Clinical Research, LLC ( Site 0680)

Tampa, Florida, 33603, United States

Location

DaVita Clinical Research - Columbus ( Site 0532)

Columbus, Georgia, 31904, United States

Location

Renal Physicians of Georgia ( Site 0577)

Macon, Georgia, 31217, United States

Location

DaVita East Georgia Dialysis Unit ( Site 0536)

Statesboro, Georgia, 30458, United States

Location

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

Chicago, Illinois, 60637, United States

Location

Nephrology Specialists - Merrillville ( Site 0537)

Merrillville, Indiana, 46410, United States

Location

Nephrology Specialists - Michigan City ( Site 0541)

Michigan City, Indiana, 46360, United States

Location

Capital Nephrology ( Site 0596)

Greenbelt, Maryland, 20770, United States

Location

Henry Ford Hospital-Nephrology and Hypertension ( Site 0694)

Detroit, Michigan, 48202, United States

Location

St. Clair Nephrology Research - Roseville ( Site 0597)

Roseville, Michigan, 48066, United States

Location

DaVita Clinical Research ( Site 0502)

Minneapolis, Minnesota, 55404, United States

Location

Fresenius Kidney Care Brookhaven ( Site 0693)

Brookhaven, Mississippi, 39601, United States

Location

Clinical Research Consultants, LLC ( Site 0542)

Kansas City, Missouri, 64111, United States

Location

Somnos Clinical Research ( Site 0669)

Lincoln, Nebraska, 68505, United States

Location

DaVita Five Star Dialysis Center ( Site 0509)

Las Vegas, Nevada, 89128, United States

Location

Renal Medicine Associates ( Site 0690)

Albuquerque, New Mexico, 87109, United States

Location

Capital District Renal Physicians ( Site 0633)

Albany, New York, 12209, United States

Location

Ridgewood Dialysis Center ( Site 0725)

Ridgewood, New York, 11385, United States

Location

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

The Bronx, New York, 10461, United States

Location

DaVita Clinical Researh ( Site 0501)

The Bronx, New York, 10461, United States

Location

Fresenius Kidney Care - Charlotte ( Site 0686)

Charlotte, North Carolina, 28208, United States

Location

Durham Nephrology Associates ( Site 0655)

Durham, North Carolina, 27704, United States

Location

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

Greenville, North Carolina, 27834, United States

Location

Kidney and Hypertension Center ( Site 0571)

Roseburg, Oregon, 97471, United States

Location

Northeast Clinical Research Center ( Site 0653)

Bethlehem, Pennsylvania, 18017, United States

Location

Elixia at Clinical Renal Associates ( Site 0677)

Upland, Pennsylvania, 19013, United States

Location

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

Orangeburg, South Carolina, 29118, United States

Location

Knoxville Kidney Center ( Site 0689)

Knoxville, Tennessee, 37923, United States

Location

Renal Disease Research Institute ( Site 0621)

Dallas, Texas, 75235, United States

Location

DaVita Clinical Research - El Paso ( Site 0505)

El Paso, Texas, 79925, United States

Location

DaVita Clinical Research - Houston ( Site 0508)

Houston, Texas, 77004, United States

Location

Clinical Research Strategies ( Site 0625)

Houston, Texas, 77090, United States

Location

Southwest Houston Research ( Site 0649)

Houston, Texas, 77099, United States

Location

Texas Institute for Kidney and Endocrine Disorders ( Site 0626)

Lufkin, Texas, 75904, United States

Location

Gamma Medical Research ( Site 0688)

McAllen, Texas, 78503, United States

Location

DaVita Clinical Research - Norfolk ( Site 0513)

Norfolk, Virginia, 23502, United States

Location

DaVita Clinical Research - Milwaukee ( Site 0512)

Wauwatosa, Wisconsin, 53226, United States

Location

FME Mansilla ( Site 0007)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425BPM, Argentina

Location

Fresenius Medical Care - Moron ( Site 0008)

Morón, Buenos Aires, B1708DPO, Argentina

Location

Fresenius Medical Care - San Fernando ( Site 0013)

San Fernando, Buenos Aires, 1646, Argentina

Location

CEREHA ( Site 0004)

Sarandí, Buenos Aires, B1872JBA, Argentina

Location

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

Buenos Aires, Buenos Aires F.D., C1431FWO, Argentina

Location

Fresenius Medical Care Ciudad Evita ( Site 0006)

Buenos Aires, B1778IFA, Argentina

Location

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

Santa Fe, 3000, Argentina

Location

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

St Albans, Victoria, 3021, Australia

Location

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

São José do Rio Preto, São Paulo, 15090000, Brazil

Location

Fresenius Clinical Trials Perdizes ( Site 0101)

São Paulo, São Paulo, 05024-030, Brazil

Location

Hospital do Rim e Hipertensão ( Site 0106)

São Paulo, 04038-002, Brazil

Location

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

Cherven Bryag, Lovech, 5980, Bulgaria

Location

MHAT Dobrich-Department for dialysis treatment ( Site 0161)

Dobrich, 9300, Bulgaria

Location

First Dialysis Services Bulgaria ( Site 0158)

Montana, 3400, Bulgaria

Location

UMBAL Plovdiv AD-Deparment of Hemodialysis ( Site 0162)

Plovdiv, 4003, Bulgaria

Location

Hemomed ( Site 0159)

Sofia, 1618, Bulgaria

Location

University Of Alberta Hospital ( Site 1001)

Edmonton, Alberta, T6G 2B7, Canada

Location

Toronto General Hospital ( Site 1002)

Toronto, Ontario, M5G 2C4, Canada

Location

Fresenius Medical Care - Dialyzační středisko ( Site 0254)

Prague, Praha 4, 142 00, Czechia

Location

Dialýza ( Site 0256)

Beroun, 266 01, Czechia

Location

Fresenius Medical Care ( Site 0253)

Pardubice, 532 03, Czechia

Location

DaVita Clinical Research Germany GmbH ( Site 0901)

Düsseldorf, North Rhine-Westphalia, 40210, Germany

Location

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

Chaïdári, Attica, 124 62, Greece

Location

Ippokrateio General Hospital of Thessaloniki ( Site 1053)

Thessaloniki, Central Macedonia, 546 42, Greece

Location

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

Thessaloniki, 570 10, Greece

Location

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

Milan, Milano, 20153, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda ( Site 0953)

Milan, 20162, Italy

Location

Fondazione Salvatore Maugeri clinica del lavoro ( Site 0955)

Pavia, 27100, Italy

Location

Fresenius Medical Care - NephroCare Covilha ( Site 0852)

Covilha, Castelo Branco District, 6200-000, Portugal

Location

Fresenius Medical Care - Nephrocare Portimao ( Site 0855)

Portimão, Faro District, 8500-311, Portugal

Location

Fresenius Medical Care - NephroCare Amadora ( Site 0851)

Amadora, Lisbon District, 2700-391, Portugal

Location

Fresenius Medical Care - NephroCare Almada ( Site 0854)

Corroios, Lisbon District, 2855-227, Portugal

Location

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

Lisbon, Lisbon District, 1750-130, Portugal

Location

Fresenius Medical Care Humacao ( Site 0354)

Humacao, 00971, Puerto Rico

Location

Fresenius Nephrocare - Brașov ( Site 0409)

Brașov, Brăila County, 500152, Romania

Location

Fresenius Nephrocare - Bucharest ( Site 0408)

Bucharest, București, 013217, Romania

Location

Fresenius Nephrocare - Cluj-Napoca ( Site 0410)

Cluj-Napoca, Cluj, 400528, Romania

Location

Fresenius Nephrocare - Iași ( Site 0406)

Iași, Iaşi, 700523, Romania

Location

Unipharm LLC ( Site 0804)

Krasnogorsk, Moscow Oblast, 143403, Russia

Location

Limited Liability Company -Nefroline-Novosibirsk ( Site 0810)

Novosibirsk, Novosibirsk Oblast, 630064, Russia

Location

Skånes Universitetssjukhus Malmö ( Site 0454)

Malmo, Skåne County, 205 02, Sweden

Location

Karolinska Universitetssjukhuset Huddinge-ME Njurmedicin ( Site 0451)

Stockholm, Stockholm County, 141 86, Sweden

Location

Akademiska sjukhuset-Njurmottagningen ( Site 0453)

Uppsala, Uppsala County, 751 85, Sweden

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: August 30, 2021
• Study Start: September 17, 2021
• Primary Completion: October 30, 2024
• Study Completion: February 13, 2025
• Last Updated: February 11, 2026
• Results First Posted: November 17, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

AR (7); CZ (3); RO (4); US (77); SE (3); RU (2); GR (3); AU (1); BR (3); BU (5); PT (5); DE (1); PR (1); IT (3); CA (2)