Clinical trial NCT05027074: 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)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End-Stage Renal Disease
End-Stage Kidney Disease
Kidney Failure, Chronic
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2021-08-30
Enrollment: 506
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Time to First AVG Thrombosis Event
timeFrame: From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 34 months
Secondary outcomes:
measure: Time to Each Arteriovenous Graft Thrombosis Event (First and Recurrent)
timeFrame: Up to approximately 34 months
measure: Number of Participants who Experience One or More Adverse Events (AEs)
timeFrame: Up to approximately 37 months
measure: Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria
timeFrame: Up to approximately 37 months
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 34 months
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Nephrology Consultants ( Site 0681)
state: Alabama
city: Phoenix
country: United States
facility: AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723)
state: Arizona
city: Tucson
country: United States
facility: AKDHC Medical Research Services, LLC ( Site 0629)
state: Arizona
city: Anaheim
country: United States
facility: DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562)
state: California
city: Bakersfield
country: United States
facility: DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547)
state: California
city: Bakersfield
country: United States
facility: Fresenius Kidney Care Bakersfield Northeast ( Site 0647)
state: California
city: Bakersfield
country: United States
facility: Fresenius Kidney Care Meadows Field ( Site 0618)
state: California
city: Chula Vista
country: United States
facility: California Institute Of Renal Research ( Site 0660)
state: California
city: Covina
country: United States
facility: Citrus Dialysis Center ( Site 0609)
state: California
city: El Centro
country: United States
facility: California Institute Of Renal Research ( Site 0679)
state: California
city: Escondido
country: United States
facility: California Institute of Renal Research ( Site 0566)
state: California
city: Fountain Valley
country: United States
facility: Fresenius Kidney Care Newhope Fountain Valley ( Site 0617)
state: California
city: Glendale
country: United States
facility: DaVita Glendale Heights ( Site 0604)
state: California
city: Glendale
country: United States
facility: DaVita West Glendale Dialysis ( Site 0579)
state: California
city: Glendale
country: United States
facility: DaVita North Glendale ( Site 0552)
state: California
city: La Mesa
country: United States
facility: California Institute of Renal Research - La Mesa ( Site 0682)
state: California
city: La Puente
country: United States
facility: La Puente Dialysis Center ( Site 0610)
state: California
city: Los Angeles
country: United States
facility: Academic Medical Research Institute ( Site 0533)
state: California
city: Los Angeles
country: United States
facility: DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548)
state: California
city: Los Angeles
country: United States
facility: DaVita Crescent Heights Dialysis Center ( Site 0574)
state: California
city: Lynwood
country: United States
facility: North America Research Institute ( Site 0587)
state: California
city: Lynwood
country: United States
facility: North America Research Institute ( Site 0612)
state: California
city: Northridge
country: United States
facility: Valley Renal Medical Group Research-Clinical Research ( Site 0651)
state: California
city: San Diego
country: United States
facility: California Institute of Renal Research - Kearny Mesa ( Site 0678)
state: California
city: San Dimas
country: United States
facility: North America Research Institute ( Site 0611)
state: California
city: Van Nuys
country: United States
facility: DaVita Van Nuys Dialysis ( Site 0538)
state: California
city: Victorville
country: United States
facility: Desert Cities Diaylsis-Clinical Research ( Site 0615)
state: California
city: Hartford
country: United States
facility: DaVita Clinical Research - Hartford ( Site 0507)
state: Connecticut
city: Middlebury
country: United States
facility: DaVita Clinical Research - Middlebury ( Site 0511)
state: Connecticut
city: Boca Raton
country: United States
facility: Research Physicians Network Alliance ( Site 0563)
state: Florida
city: Coral Gables
country: United States
facility: Horizon Research Group ( Site 0578)
state: Florida
city: Coral Gables
country: United States
facility: Horizon Research Group ( Site 0581)
state: Florida
city: Fort Lauderdale
country: United States
facility: Elixia at Florida Kidney Physicians - Southeast ( Site 0602)
state: Florida
city: Fort Lauderdale
country: United States
facility: South Florida Research Institute ( Site 0656)
state: Florida
city: Hollywood
country: United States
facility: Elixia Clinical Research Collaborative (CRC) - Southeast Florida ( Site 0728)
state: Florida
city: Hollywood
country: United States
facility: Pines Clinical Research ( Site 0605)
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC ( Site 0684)
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando ( Site 0645)
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC ( Site 0585)
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC ( Site 0594)
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC ( Site 0680)
state: Florida
city: Columbus
country: United States
facility: DaVita Clinical Research - Columbus ( Site 0532)
state: Georgia
city: Macon
country: United States
facility: Renal Physicians of Georgia ( Site 0577)
state: Georgia
city: Statesboro
country: United States
facility: DaVita East Georgia Dialysis Unit ( Site 0536)
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center-Medicine - Section of Nephrology ( Site 0595)
state: Illinois
city: Merrillville
country: United States
facility: Nephrology Specialists - Merrillville ( Site 0537)
state: Indiana
city: Michigan City
country: United States
facility: Nephrology Specialists - Michigan City ( Site 0541)
state: Indiana
city: Greenbelt
country: United States
facility: Capital Nephrology ( Site 0596)
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital-Nephrology and Hypertension ( Site 0694)
state: Michigan
city: Roseville
country: United States
facility: St. Clair Nephrology Research - Roseville ( Site 0597)
state: Michigan
city: Minneapolis
country: United States
facility: DaVita Clinical Research ( Site 0502)
state: Minnesota
city: Brookhaven
country: United States
facility: Fresenius Kidney Care Brookhaven ( Site 0693)
state: Mississippi
city: Kansas City
country: United States
facility: Clinical Research Consultants, LLC ( Site 0542)
state: Missouri
city: Lincoln
country: United States
facility: Somnos Clinical Research ( Site 0669)
state: Nebraska
city: Las Vegas
country: United States
facility: DaVita Five Star Dialysis Center ( Site 0509)
state: Nevada
city: Albuquerque
country: United States
facility: Renal Medicine Associates ( Site 0690)
state: New Mexico
city: Albany
country: United States
facility: Capital District Renal Physicians ( Site 0633)
state: New York
city: Bronx
country: United States
facility: Albert Einstein College of Medicine-Department of Medicine-Nephrology Einstein ( Site 0628)
state: New York
city: Bronx
country: United States
facility: DaVita Clinical Researh ( Site 0501)
state: New York
city: Ridgewood
country: United States
facility: Ridgewood Dialysis Center ( Site 0725)
state: New York
city: Charlotte
country: United States
facility: Fresenius Kidney Care - Charlotte ( Site 0686)
state: North Carolina
city: Durham
country: United States
facility: Durham Nephrology Associates ( Site 0655)
state: North Carolina
city: Greenville
country: United States
facility: East Carolina University-Department of Nephrology & Hypertension ( Site 0663)
state: North Carolina
city: Roseburg
country: United States
facility: Kidney and Hypertension Center ( Site 0571)
state: Oregon
city: Bethlehem
country: United States
facility: Northeast Clinical Research Center ( Site 0653)
state: Pennsylvania
city: Upland
country: United States
facility: Elixia at Clinical Renal Associates ( Site 0677)
state: Pennsylvania
city: Orangeburg
country: United States
facility: South Carolina Nephrology & Hypertension Center-Research ( Site 0672)
state: South Carolina
city: Knoxville
country: United States
facility: Knoxville Kidney Center ( Site 0689)
state: Tennessee
city: Dallas
country: United States
facility: Renal Disease Research Institute ( Site 0621)
state: Texas
city: El Paso
country: United States
facility: DaVita Clinical Research - El Paso ( Site 0505)
state: Texas
city: Houston
country: United States
facility: DaVita Clinical Research - Houston ( Site 0508)
state: Texas
city: Houston
country: United States
facility: Clinical Research Strategies ( Site 0625)
state: Texas
city: Houston
country: United States
facility: Southwest Houston Research ( Site 0649)
state: Texas
city: Lufkin
country: United States
facility: Texas Institute for Kidney and Endocrine Disorders ( Site 0626)
state: Texas
city: McAllen
country: United States
facility: Gamma Medical Research ( Site 0688)
state: Texas
city: Norfolk
country: United States
facility: DaVita Clinical Research - Norfolk ( Site 0513)
state: Virginia
city: Wauwatosa
country: United States
facility: DaVita Clinical Research - Milwaukee ( Site 0512)
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: FME Mansilla ( Site 0007)
state: Buenos Aires
city: Morón
country: Argentina
facility: Fresenius Medical Care - Moron ( Site 0008)
state: Buenos Aires
city: San Fernando
country: Argentina
facility: Fresenius Medical Care - San Fernando ( Site 0013)
state: Buenos Aires
city: Sarandi
country: Argentina
facility: CEREHA ( Site 0004)
state: Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0010)
state: Caba
city: Buenos Aires
country: Argentina
facility: Fresenius Medical Care Ciudad Evita ( Site 0006)
city: Santa Fe
country: Argentina
facility: Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0001)
city: St Albans
country: Australia
facility: Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054)
state: Victoria
city: São José do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: Fresenius Clinical Trials Perdizes ( Site 0101)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Hospital do Rim e Hipertensão ( Site 0106)
city: Cherven bryag
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - "Dr. Cherven Bryag"-Department of dialysis treatment (
state: Lovech
city: Dobrich
country: Bulgaria
facility: MHAT Dobrich-Department for dialysis treatment ( Site 0161)
city: Montana
country: Bulgaria
facility: First Dialysis Services Bulgaria ( Site 0158)
city: Plovdiv
country: Bulgaria
facility: UMBAL Plovdiv AD-Deparment of Hemodialysis ( Site 0162)
city: Sofia
country: Bulgaria
facility: Hemomed ( Site 0159)
city: Edmonton
country: Canada
facility: University Of Alberta Hospital ( Site 1001)
state: Alberta
city: Toronto
country: Canada
facility: Toronto General Hospital ( Site 1002)
state: Ontario
city: Prague
country: Czechia
facility: Fresenius Medical Care - Dialyzační středisko ( Site 0254)
state: Praha 4
city: Beroun
country: Czechia
facility: Dialýza ( Site 0256)
city: Pardubice
country: Czechia
facility: Fresenius Medical Care ( Site 0253)
city: Düsseldorf
country: Germany
facility: DaVita Clinical Research Germany GmbH ( Site 0901)
state: Nordrhein-Westfalen
city: Chaidari
country: Greece
facility: ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Sit
state: Attiki
city: Thessaloniki
country: Greece
facility: Ippokrateio General Hospital of Thessaloniki ( Site 1053)
state: Kentriki Makedonia
city: Thessaloniki
country: Greece
facility: G. Papanikolaou General Hospital-Nephrology Department ( Site 1052)
city: Milan
country: Italy
facility: P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO ( Site 0954)
state: Milano
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda ( Site 0953)
city: Pavia
country: Italy
facility: Fondazione Salvatore Maugeri clinica del lavoro ( Site 0955)
city: Covilhã
country: Portugal
facility: Fresenius Medical Care - NephroCare Covilha ( Site 0852)
state: Castelo Branco
city: Portimão
country: Portugal
facility: Fresenius Medical Care - Nephrocare Portimao ( Site 0855)
state: Faro
city: Amadora
country: Portugal
facility: Fresenius Medical Care - NephroCare Amadora ( Site 0851)
state: Lisboa
city: Corroios
country: Portugal
facility: Fresenius Medical Care - NephroCare Almada ( Site 0854)
state: Lisboa
city: Lisbon
country: Portugal
facility: Dyalisis Center - Clinic NephroCare Lumiar -Fresenius ( Site 0853)
state: Lisboa
city: Humacao
country: Puerto Rico
facility: Fresenius Medical Care Humacao ( Site 0354)
city: Brașov
country: Romania
facility: Fresenius Nephrocare - Brașov ( Site 0409)
state: Braila
city: Bucharest
country: Romania
facility: Fresenius Nephrocare - Bucharest ( Site 0408)
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Fresenius Nephrocare - Cluj-Napoca ( Site 0410)
state: Cluj
city: Iași
country: Romania
facility: Fresenius Nephrocare - Iași ( Site 0406)
state: Iasi
city: Krasnogorsk
country: Russian Federation
facility: Unipharm LLC ( Site 0804)
state: Moskovskaya Oblast
city: Novosibirsk
country: Russian Federation
facility: Limited Liability Company -Nefroline-Novosibirsk ( Site 0810)
state: Novosibirskaya Oblast
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus Malmö ( Site 0454)
state: Skane Lan
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Huddinge-ME Njurmedicin ( Site 0451)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset-Njurmottagningen ( Site 0453)
state: Uppsala Lan
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: