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)
- Conditions
- Kidney Failure, ChronicEnd-Stage Renal DiseaseEnd-Stage Kidney Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT05027074
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 506
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo (normal saline) administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1 MK-2060 Low Dose MK-2060 MK-2060 low dose administered via intravenous (IV) infusion as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1 MK-2060 High Dose MK-2060 MK-2060 high dose administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
- Primary Outcome Measures
Name Time Method Time to First AVG Thrombosis Event From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 34 months 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. This endpoint will be adjudicated by an independent clinical adjudication committee (CAC).
- Secondary Outcome Measures
Name Time Method Number of Participants who Experience One or More Adverse Events (AEs) Up to approximately 37 months 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.
Number of Participants Who Discontinue Study Intervention Due to an AE Up to approximately 34 months 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.
Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria Up to approximately 37 months Major bleeding events will be defined as having a symptomatic presentation and including one or more 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 a decrease in hematocrit level of 20 g/L or more or leading to transfusion of 2 or more units of whole blood or red cells.
Clinically relevant non-major bleeding events will be defined as having signs or symptoms of hemorrhage that do not meet the criteria for major bleeding events, but do meet at least 1 of the following criteria: 1) Requiring medical intervention by a healthcare professional 2) Leading to hospitalization or increased level of care 3) Prompting a face to face evaluation by a healthcare professional.Time to Each Arteriovenous Graft Thrombosis Event (First and Recurrent) Up to approximately 34 months 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. This endpoint will be adjudicated by an independent CAC.
Trial Locations
- Locations (120)
Academic Medical Research Institute ( Site 0533)
🇺🇸Los Angeles, California, United States
Fresenius Kidney Care Newhope Fountain Valley ( Site 0617)
🇺🇸Fountain Valley, California, United States
DaVita Crescent Heights Dialysis Center ( Site 0574)
🇺🇸Los Angeles, California, United States
DaVita Clinical Researh ( Site 0501)
🇺🇸Bronx, New York, United States
St. Clair Nephrology Research - Roseville ( Site 0597)
🇺🇸Roseville, Michigan, United States
California Institute of Renal Research - Kearny Mesa ( Site 0678)
🇺🇸San Diego, California, United States
DaVita Clinical Research ( Site 0502)
🇺🇸Minneapolis, Minnesota, United States
Durham Nephrology Associates ( Site 0655)
🇺🇸Durham, North Carolina, United States
Henry Ford Hospital-Nephrology and Hypertension ( Site 0694)
🇺🇸Detroit, Michigan, United States
DaVita Five Star Dialysis Center ( Site 0509)
🇺🇸Las Vegas, Nevada, United States
Fresenius Medical Care - San Fernando ( Site 0013)
🇦🇷San Fernando, Buenos Aires, Argentina
AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723)
🇺🇸Phoenix, Arizona, United States
Dyalisis Center - Clinic NephroCare Lumiar -Fresenius ( Site 0853)
🇵🇹Lisbon, Lisboa, Portugal
Fresenius Kidney Care Brookhaven ( Site 0693)
🇺🇸Brookhaven, Mississippi, United States
University Of Alberta Hospital ( Site 1001)
🇨🇦Edmonton, Alberta, Canada
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0010)
🇦🇷Ciudad Autónoma de Buenos Aires, Caba, Argentina
Fresenius Nephrocare - Brașov ( Site 0409)
🇷🇴Brașov, Braila, Romania
DaVita Clinical Research - Hartford ( Site 0507)
🇺🇸Hartford, Connecticut, United States
Somnos Clinical Research ( Site 0669)
🇺🇸Lincoln, Nebraska, United States
FME Mansilla ( Site 0007)
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hemomed ( Site 0159)
🇧🇬Sofia, Bulgaria
ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Sit
🇬🇷Chaidari, Attiki, Greece
Fresenius Medical Care - Moron ( Site 0008)
🇦🇷Morón, Buenos Aires, Argentina
CEREHA ( Site 0004)
🇦🇷Sarandi, Buenos Aires, Argentina
UMBAL Plovdiv AD-Deparment of Hemodialysis ( Site 0162)
🇧🇬Plovdiv, Bulgaria
Fresenius Medical Care - NephroCare Covilha ( Site 0852)
🇵🇹Covilhã, Castelo Branco, Portugal
Fresenius Medical Care - NephroCare Almada ( Site 0854)
🇵🇹Corroios, Lisboa, Portugal
Limited Liability Company -Nefroline-Novosibirsk ( Site 0810)
🇷🇺Novosibirsk, Novosibirskaya Oblast, Russian Federation
MHAT Dobrich-Department for dialysis treatment ( Site 0161)
🇧🇬Dobrich, Bulgaria
Ippokrateio General Hospital of Thessaloniki ( Site 1053)
🇬🇷Thessaloniki, Kentriki Makedonia, Greece
Fresenius Nephrocare - Cluj-Napoca ( Site 0410)
🇷🇴Cluj-Napoca, Cluj, Romania
Fresenius Nephrocare - Iași ( Site 0406)
🇷🇴Iași, Iasi, Romania
Genesis Clinical Research, LLC ( Site 0585)
🇺🇸Tampa, Florida, United States
Genesis Clinical Research, LLC ( Site 0594)
🇺🇸Tampa, Florida, United States
Genesis Clinical Research, LLC ( Site 0680)
🇺🇸Tampa, Florida, United States
Nephrology Consultants ( Site 0681)
🇺🇸Huntsville, Alabama, United States
DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562)
🇺🇸Anaheim, California, United States
DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547)
🇺🇸Bakersfield, California, United States
Fresenius Kidney Care Bakersfield Northeast ( Site 0647)
🇺🇸Bakersfield, California, United States
California Institute Of Renal Research ( Site 0660)
🇺🇸Chula Vista, California, United States
Citrus Dialysis Center ( Site 0609)
🇺🇸Covina, California, United States
DaVita Glendale Heights ( Site 0604)
🇺🇸Glendale, California, United States
California Institute Of Renal Research ( Site 0679)
🇺🇸El Centro, California, United States
California Institute of Renal Research ( Site 0566)
🇺🇸Escondido, California, United States
DaVita West Glendale Dialysis ( Site 0579)
🇺🇸Glendale, California, United States
DaVita North Glendale ( Site 0552)
🇺🇸Glendale, California, United States
California Institute of Renal Research - La Mesa ( Site 0682)
🇺🇸La Mesa, California, United States
La Puente Dialysis Center ( Site 0610)
🇺🇸La Puente, California, United States
DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548)
🇺🇸Los Angeles, California, United States
Valley Renal Medical Group Research-Clinical Research ( Site 0651)
🇺🇸Northridge, California, United States
North America Research Institute ( Site 0612)
🇺🇸Lynwood, California, United States
North America Research Institute ( Site 0587)
🇺🇸Lynwood, California, United States
North America Research Institute ( Site 0611)
🇺🇸San Dimas, California, United States
DaVita Van Nuys Dialysis ( Site 0538)
🇺🇸Van Nuys, California, United States
Research Physicians Network Alliance ( Site 0563)
🇺🇸Boca Raton, Florida, United States
DaVita Clinical Research - Middlebury ( Site 0511)
🇺🇸Middlebury, Connecticut, United States
Horizon Research Group ( Site 0581)
🇺🇸Coral Gables, Florida, United States
Elixia at Florida Kidney Physicians - Southeast ( Site 0602)
🇺🇸Fort Lauderdale, Florida, United States
Horizon Research Group ( Site 0578)
🇺🇸Coral Gables, Florida, United States
Elixia Clinical Research Collaborative (CRC) - Southeast Florida ( Site 0728)
🇺🇸Hollywood, Florida, United States
South Florida Research Institute ( Site 0656)
🇺🇸Fort Lauderdale, Florida, United States
Pines Clinical Research ( Site 0605)
🇺🇸Hollywood, Florida, United States
Floridian Clinical Research, LLC ( Site 0684)
🇺🇸Miami Lakes, Florida, United States
Nephrology Specialists - Merrillville ( Site 0537)
🇺🇸Merrillville, Indiana, United States
DaVita Clinical Research - Columbus ( Site 0532)
🇺🇸Columbus, Georgia, United States
DaVita East Georgia Dialysis Unit ( Site 0536)
🇺🇸Statesboro, Georgia, United States
University of Chicago Medical Center-Medicine - Section of Nephrology ( Site 0595)
🇺🇸Chicago, Illinois, United States
Capital Nephrology ( Site 0596)
🇺🇸Greenbelt, Maryland, United States
Nephrology Specialists - Michigan City ( Site 0541)
🇺🇸Michigan City, Indiana, United States
Capital District Renal Physicians ( Site 0633)
🇺🇸Albany, New York, United States
Renal Medicine Associates ( Site 0690)
🇺🇸Albuquerque, New Mexico, United States
Albert Einstein College of Medicine-Department of Medicine-Nephrology Einstein ( Site 0628)
🇺🇸Bronx, New York, United States
Ridgewood Dialysis Center ( Site 0725)
🇺🇸Ridgewood, New York, United States
Fresenius Kidney Care - Charlotte ( Site 0686)
🇺🇸Charlotte, North Carolina, United States
Northeast Clinical Research Center ( Site 0653)
🇺🇸Bethlehem, Pennsylvania, United States
Kidney and Hypertension Center ( Site 0571)
🇺🇸Roseburg, Oregon, United States
Elixia at Clinical Renal Associates ( Site 0677)
🇺🇸Upland, Pennsylvania, United States
South Carolina Nephrology & Hypertension Center-Research ( Site 0672)
🇺🇸Orangeburg, South Carolina, United States
East Carolina University-Department of Nephrology & Hypertension ( Site 0663)
🇺🇸Greenville, North Carolina, United States
Knoxville Kidney Center ( Site 0689)
🇺🇸Knoxville, Tennessee, United States
DaVita Clinical Research - El Paso ( Site 0505)
🇺🇸El Paso, Texas, United States
Renal Disease Research Institute ( Site 0621)
🇺🇸Dallas, Texas, United States
DaVita Clinical Research - Houston ( Site 0508)
🇺🇸Houston, Texas, United States
Clinical Research Strategies ( Site 0625)
🇺🇸Houston, Texas, United States
Southwest Houston Research ( Site 0649)
🇺🇸Houston, Texas, United States
Texas Institute for Kidney and Endocrine Disorders ( Site 0626)
🇺🇸Lufkin, Texas, United States
Gamma Medical Research ( Site 0688)
🇺🇸McAllen, Texas, United States
DaVita Clinical Research - Norfolk ( Site 0513)
🇺🇸Norfolk, Virginia, United States
DaVita Clinical Research - Milwaukee ( Site 0512)
🇺🇸Wauwatosa, Wisconsin, United States
Fresenius Medical Care Ciudad Evita ( Site 0006)
🇦🇷Buenos Aires, Argentina
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0001)
🇦🇷Santa Fe, Argentina
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
🇧🇷São José do Rio Preto, Sao Paulo, Brazil
Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054)
🇦🇺St Albans, Victoria, Australia
Fresenius Clinical Trials Perdizes ( Site 0101)
🇧🇷São Paulo, Sao Paulo, Brazil
Hospital do Rim e Hipertensão ( Site 0106)
🇧🇷Sao Paulo, Brazil
Multiprofile Hospital for Active Treatment - "Dr. Cherven Bryag"-Department of dialysis treatment (
🇧🇬Cherven bryag, Lovech, Bulgaria
First Dialysis Services Bulgaria ( Site 0158)
🇧🇬Montana, Bulgaria
Toronto General Hospital ( Site 1002)
🇨🇦Toronto, Ontario, Canada
Fresenius Medical Care - Dialyzační středisko ( Site 0254)
🇨🇿Prague, Praha 4, Czechia
Dialýza ( Site 0256)
🇨🇿Beroun, Czechia
Fresenius Medical Care ( Site 0253)
🇨🇿Pardubice, Czechia
DaVita Clinical Research Germany GmbH ( Site 0901)
🇩🇪Düsseldorf, Nordrhein-Westfalen, Germany
G. Papanikolaou General Hospital-Nephrology Department ( Site 1052)
🇬🇷Thessaloniki, Greece
ASST Grande Ospedale Metropolitano Niguarda ( Site 0953)
🇮🇹Milano, Italy
P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO ( Site 0954)
🇮🇹Milan, Milano, Italy
Fondazione Salvatore Maugeri clinica del lavoro ( Site 0955)
🇮🇹Pavia, Italy
Fresenius Medical Care - NephroCare Amadora ( Site 0851)
🇵🇹Amadora, Lisboa, Portugal
Fresenius Medical Care - Nephrocare Portimao ( Site 0855)
🇵🇹Portimão, Faro, Portugal
Fresenius Medical Care Humacao ( Site 0354)
🇵🇷Humacao, Puerto Rico
Fresenius Nephrocare - Bucharest ( Site 0408)
🇷🇴Bucharest, Bucuresti, Romania
Skånes Universitetssjukhus Malmö ( Site 0454)
🇸🇪Malmö, Skane Lan, Sweden
Unipharm LLC ( Site 0804)
🇷🇺Krasnogorsk, Moskovskaya Oblast, Russian Federation
Karolinska Universitetssjukhuset Huddinge-ME Njurmedicin ( Site 0451)
🇸🇪Stockholm, Stockholms Lan, Sweden
Akademiska sjukhuset-Njurmottagningen ( Site 0453)
🇸🇪Uppsala, Uppsala Lan, Sweden
Fresenius Kidney Care Meadows Field ( Site 0618)
🇺🇸Bakersfield, California, United States
Renal Physicians of Georgia ( Site 0577)
🇺🇸Macon, Georgia, United States
Omega Research Orlando ( Site 0645)
🇺🇸Orlando, Florida, United States
Clinical Research Consultants, LLC ( Site 0542)
🇺🇸Kansas City, Missouri, United States
AKDHC Medical Research Services, LLC ( Site 0629)
🇺🇸Tucson, Arizona, United States
Desert Cities Diaylsis-Clinical Research ( Site 0615)
🇺🇸Victorville, California, United States