Kidney Failure, Chronic Clinical Trial
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
| Verified date | September 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 | 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Brazil, Bulgaria, Canada, Czechia, Germany, Greece, Italy, Portugal, Puerto Rico, Romania, Russian Federation, Sweden,
| 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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