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
- Diseases
- Chronic kidney disease
- 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
Sites (120)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0010) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fresenius Medical Care Ciudad Evita ( Site 0006) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| FME Mansilla ( Site 0007) Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| Fresenius Medical Care - Moron ( Site 0008) Coordinator of this site? Confirm its status | Morón | Argentina | Unknown status |
| Fresenius Medical Care - San Fernando ( Site 0013) Coordinator of this site? Confirm its status | San Fernando | Argentina | Unknown status |
| Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0001) Coordinator of this site? Confirm its status | Santa Fe | Argentina | Unknown status |
| CEREHA ( Site 0004) Coordinator of this site? Confirm its status | Sarandí | Argentina | Unknown status |
| Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054) Coordinator of this site? Confirm its status | St Albans | Australia | Unknown status |
| Multiprofile Hospital for Active Treatment - "Dr. Cherven Bryag"-Department of dialysis treatment ( Coordinator of this site? Confirm its status | Cherven Bryag | Bulgaria | Unknown status |
| MHAT Dobrich-Department for dialysis treatment ( Site 0161) Coordinator of this site? Confirm its status | Dobrich | Bulgaria | Unknown status |
| First Dialysis Services Bulgaria ( Site 0158) Coordinator of this site? Confirm its status | Montana | Bulgaria | Unknown status |
| UMBAL Plovdiv AD-Deparment of Hemodialysis ( Site 0162) Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Unknown status |
| Hemomed ( Site 0159) Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown 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 Preto | Brazil | Unknown status |
| Hospital do Rim e Hipertensão ( Site 0106) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Fresenius Clinical Trials Perdizes ( Site 0101) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| University Of Alberta Hospital ( Site 1001) Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Toronto General Hospital ( Site 1002) Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Dialýza ( Site 0256) Coordinator of this site? Confirm its status | Beroun | Czechia | Unknown status |
| Fresenius Medical Care ( Site 0253) Coordinator of this site? Confirm its status | Pardubice | Czechia | Unknown status |
| Fresenius Medical Care - Dialyzační středisko ( Site 0254) Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| DaVita Clinical Research Germany GmbH ( Site 0901) Coordinator of this site? Confirm its status | Düsseldorf | Germany | Unknown status |
| ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Sit Coordinator of this site? Confirm its status | Chaïdári | Greece | Unknown status |
| G. Papanikolaou General Hospital-Nephrology Department ( Site 1052) Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| Ippokrateio General Hospital of Thessaloniki ( Site 1053) Coordinator of this site? Confirm its status | Thessaloniki | Greece | Unknown status |
| P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO ( Site 0954) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda ( Site 0953) Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione Salvatore Maugeri clinica del lavoro ( Site 0955) Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Fresenius Medical Care Humacao ( Site 0354) Coordinator of this site? Confirm its status | Humacao | Puerto Rico | Unknown status |
| Fresenius Medical Care - NephroCare Amadora ( Site 0851) Coordinator of this site? Confirm its status | Amadora | Portugal | Unknown status |
| Fresenius Medical Care - NephroCare Almada ( Site 0854) Coordinator of this site? Confirm its status | Corroios | Portugal | Unknown status |
| Fresenius Medical Care - NephroCare Covilha ( Site 0852) Coordinator of this site? Confirm its status | Covilha | Portugal | Unknown status |
| Dyalisis Center - Clinic NephroCare Lumiar -Fresenius ( Site 0853) Coordinator of this site? Confirm its status | Lisbon | Portugal | Unknown status |
| Fresenius Medical Care - Nephrocare Portimao ( Site 0855) Coordinator of this site? Confirm its status | Portimão | Portugal | Unknown status |
| Fresenius Nephrocare - Brașov ( Site 0409) Coordinator of this site? Confirm its status | Brașov | Romania | Unknown status |
| Fresenius Nephrocare - Bucharest ( Site 0408) Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Fresenius Nephrocare - Cluj-Napoca ( Site 0410) Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| Fresenius Nephrocare - Iași ( Site 0406) Coordinator of this site? Confirm its status | Iași | Romania | Unknown status |
| Unipharm LLC ( Site 0804) Coordinator of this site? Confirm its status | Krasnogorsk | Russia | Unknown status |
| Limited Liability Company -Nefroline-Novosibirsk ( Site 0810) Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| Skånes Universitetssjukhus Malmö ( Site 0454) Coordinator of this site? Confirm its status | Malmö | Sweden | Unknown status |
| Karolinska Universitetssjukhuset Huddinge-ME Njurmedicin ( Site 0451) Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
| Akademiska sjukhuset-Njurmottagningen ( Site 0453) Coordinator of this site? Confirm its status | Uppsala | Sweden | Unknown status |
| Capital District Renal Physicians ( Site 0633) Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Renal Medicine Associates ( Site 0690) Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562) Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Fresenius Kidney Care Bakersfield Northeast ( Site 0647) Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Fresenius Kidney Care Meadows Field ( Site 0618) Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547) Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Northeast Clinical Research Center ( Site 0653) Coordinator of this site? Confirm its status | Bethlehem | United States | Unknown status |
| Research Physicians Network Alliance ( Site 0563) Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Fresenius Kidney Care Brookhaven ( Site 0693) Coordinator of this site? Confirm its status | Brookhaven | United States | Unknown status |
| Fresenius Kidney Care - Charlotte ( Site 0686) Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| University of Chicago Medical Center-Medicine - Section of Nephrology ( Site 0595) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| California Institute Of Renal Research ( Site 0660) Coordinator of this site? Confirm its status | Chula Vista | United States | Unknown status |
| DaVita Clinical Research - Columbus ( Site 0532) Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Horizon Research Group ( Site 0578) Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Horizon Research Group ( Site 0581) Coordinator of this site? Confirm its status | Coral Gables | United States | Unknown status |
| Citrus Dialysis Center ( Site 0609) Coordinator of this site? Confirm its status | Covina | United States | Unknown status |
| Renal Disease Research Institute ( Site 0621) Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Henry Ford Hospital-Nephrology and Hypertension ( Site 0694) Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Durham Nephrology Associates ( Site 0655) Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| California Institute Of Renal Research ( Site 0679) Coordinator of this site? Confirm its status | El Centro | United States | Unknown status |
| DaVita Clinical Research - El Paso ( Site 0505) Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| California Institute of Renal Research ( Site 0566) Coordinator of this site? Confirm its status | Escondido | United States | Unknown status |
| Elixia at Florida Kidney Physicians - Southeast ( Site 0602) Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| South Florida Research Institute ( Site 0656) Coordinator of this site? Confirm its status | Fort Lauderdale | United States | Unknown status |
| Fresenius Kidney Care Newhope Fountain Valley ( Site 0617) Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| DaVita North Glendale ( Site 0552) Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| DaVita Glendale Heights ( Site 0604) Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| DaVita West Glendale Dialysis ( Site 0579) Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Capital Nephrology ( Site 0596) Coordinator of this site? Confirm its status | Greenbelt | United States | Unknown status |
| East Carolina University-Department of Nephrology & Hypertension ( Site 0663) Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| DaVita Clinical Research - Hartford ( Site 0507) Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Pines Clinical Research ( Site 0605) Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| Elixia Clinical Research Collaborative (CRC) - Southeast Florida ( Site 0728) Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| DaVita Clinical Research - Houston ( Site 0508) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Clinical Research Strategies ( Site 0625) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Southwest Houston Research ( Site 0649) Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Nephrology Consultants ( Site 0681) Coordinator of this site? Confirm its status | Huntsville | United States | Unknown status |
| Clinical Research Consultants, LLC ( Site 0542) Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Knoxville Kidney Center ( Site 0689) Coordinator of this site? Confirm its status | Knoxville | United States | Unknown status |
| California Institute of Renal Research - La Mesa ( Site 0682) Coordinator of this site? Confirm its status | La Mesa | United States | Unknown status |
| La Puente Dialysis Center ( Site 0610) Coordinator of this site? Confirm its status | La Puente | United States | Unknown status |
| DaVita Five Star Dialysis Center ( Site 0509) Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Somnos Clinical Research ( Site 0669) Coordinator of this site? Confirm its status | Lincoln | United States | Unknown status |
| DaVita Crescent Heights Dialysis Center ( Site 0574) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Academic Medical Research Institute ( Site 0533) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548) Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Texas Institute for Kidney and Endocrine Disorders ( Site 0626) Coordinator of this site? Confirm its status | Lufkin | United States | Unknown status |
| North America Research Institute ( Site 0587) Coordinator of this site? Confirm its status | Lynwood | United States | Unknown status |
| North America Research Institute ( Site 0612) Coordinator of this site? Confirm its status | Lynwood | United States | Unknown status |
| Renal Physicians of Georgia ( Site 0577) Coordinator of this site? Confirm its status | Macon | United States | Unknown status |
| Gamma Medical Research ( Site 0688) Coordinator of this site? Confirm its status | McAllen | United States | Unknown status |
| Nephrology Specialists - Merrillville ( Site 0537) Coordinator of this site? Confirm its status | Merrillville | United States | Unknown status |
| Floridian Clinical Research, LLC ( Site 0684) Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| Nephrology Specialists - Michigan City ( Site 0541) Coordinator of this site? Confirm its status | Michigan City | United States | Unknown status |
| DaVita Clinical Research - Middlebury ( Site 0511) Coordinator of this site? Confirm its status | Middlebury | United States | Unknown status |
| DaVita Clinical Research ( Site 0502) Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| DaVita Clinical Research - Norfolk ( Site 0513) Coordinator of this site? Confirm its status | Norfolk | United States | Unknown status |
| Valley Renal Medical Group Research-Clinical Research ( Site 0651) Coordinator of this site? Confirm its status | Northridge | United States | Unknown status |
| South Carolina Nephrology & Hypertension Center-Research ( Site 0672) Coordinator of this site? Confirm its status | Orangeburg | United States | Unknown status |
| Omega Research Orlando ( Site 0645) Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Ridgewood Dialysis Center ( Site 0725) Coordinator of this site? Confirm its status | Ridgewood | United States | Unknown status |
| Kidney and Hypertension Center ( Site 0571) Coordinator of this site? Confirm its status | Roseburg | United States | Unknown status |
| St. Clair Nephrology Research - Roseville ( Site 0597) Coordinator of this site? Confirm its status | Roseville | United States | Unknown status |
| California Institute of Renal Research - Kearny Mesa ( Site 0678) Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| North America Research Institute ( Site 0611) Coordinator of this site? Confirm its status | San Dimas | United States | Unknown status |
| DaVita East Georgia Dialysis Unit ( Site 0536) Coordinator of this site? Confirm its status | Statesboro | United States | Unknown status |
| Genesis Clinical Research, LLC ( Site 0594) Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Genesis Clinical Research, LLC ( Site 0585) Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Genesis Clinical Research, LLC ( Site 0680) Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Albert Einstein College of Medicine-Department of Medicine-Nephrology Einstein ( Site 0628) Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| DaVita Clinical Researh ( Site 0501) Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| AKDHC Medical Research Services, LLC ( Site 0629) Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
| Elixia at Clinical Renal Associates ( Site 0677) Coordinator of this site? Confirm its status | Upland | United States | Unknown status |
| DaVita Van Nuys Dialysis ( Site 0538) Coordinator of this site? Confirm its status | Van Nuys | United States | Unknown status |
| Desert Cities Diaylsis-Clinical Research ( Site 0615) Coordinator of this site? Confirm its status | Victorville | United States | Unknown status |
| DaVita Clinical Research - Milwaukee ( Site 0512) Coordinator of this site? Confirm its status | Wauwatosa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.