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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05027074
Other study ID # 2060-007
Secondary ID MK-2060-0072020-
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 17, 2021
Est. completion date October 31, 2024

Study information

Verified date September 2023
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 489
Est. completion date October 31, 2024
Est. primary completion date July 10, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
MK-2060
MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion
Placebo
Normal saline administered via IV infusion

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Czechia,  Germany,  Greece,  Italy,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to First 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. This endpoint will be adjudicated by an independent clinical adjudication committee (CAC). From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 34 months
Secondary Time to Each Arteriovenous Graft 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. This endpoint will be adjudicated by an independent CAC. Up to approximately 34 months
Secondary 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. Up to approximately 37 months
Secondary Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria 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.
Up to approximately 37 months
Secondary 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. Up to approximately 34 months
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