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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)

Primary Purpose

End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MK-2060
Placebo
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for End-Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nephrology Consultants ( Site 0681)
  • AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723)
  • AKDHC Medical Research Services, LLC ( Site 0629)
  • DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562)
  • DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547)
  • Fresenius Kidney Care Bakersfield Northeast ( Site 0647)
  • Fresenius Kidney Care Meadows Field ( Site 0618)
  • California Institute Of Renal Research ( Site 0660)
  • Citrus Dialysis Center ( Site 0609)
  • California Institute Of Renal Research ( Site 0679)
  • California Institute of Renal Research ( Site 0566)
  • Fresenius Kidney Care Newhope Fountain Valley ( Site 0617)
  • DaVita Glendale Heights ( Site 0604)
  • DaVita West Glendale Dialysis ( Site 0579)
  • DaVita North Glendale ( Site 0552)
  • California Institute of Renal Research - La Mesa ( Site 0682)
  • La Puente Dialysis Center ( Site 0610)
  • Academic Medical Research Institute ( Site 0533)
  • DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548)
  • DaVita Crescent Heights Dialysis Center ( Site 0574)
  • North America Research Institute ( Site 0587)
  • North America Research Institute ( Site 0612)
  • Valley Renal Medical Group Research-Clinical Research ( Site 0651)
  • California Institute of Renal Research - Kearny Mesa ( Site 0678)
  • North America Research Institute ( Site 0611)
  • DaVita Van Nuys Dialysis ( Site 0538)
  • Desert Cities Diaylsis-Clinical Research ( Site 0615)
  • DaVita Clinical Research - Hartford ( Site 0507)
  • DaVita Clinical Research - Middlebury ( Site 0511)
  • Research Physicians Network Alliance ( Site 0563)
  • Horizon Research Group ( Site 0578)
  • Horizon Research Group ( Site 0581)
  • Elixia at Florida Kidney Physicians - Southeast ( Site 0602)
  • South Florida Research Institute ( Site 0656)
  • Elixia Clinical Research Collaborative (CRC) - Southeast Florida ( Site 0728)
  • Pines Clinical Research ( Site 0605)
  • Floridian Clinical Research, LLC ( Site 0684)
  • Omega Research Orlando ( Site 0645)
  • Genesis Clinical Research, LLC ( Site 0585)
  • Genesis Clinical Research, LLC ( Site 0594)
  • Genesis Clinical Research, LLC ( Site 0680)
  • DaVita Clinical Research - Columbus ( Site 0532)
  • Renal Physicians of Georgia ( Site 0577)
  • DaVita East Georgia Dialysis Unit ( Site 0536)
  • University of Chicago Medical Center-Medicine - Section of Nephrology ( Site 0595)
  • Nephrology Specialists - Merrillville ( Site 0537)
  • Nephrology Specialists - Michigan City ( Site 0541)
  • Capital Nephrology ( Site 0596)
  • Henry Ford Hospital-Nephrology and Hypertension ( Site 0694)
  • St. Clair Nephrology Research - Roseville ( Site 0597)
  • DaVita Clinical Research ( Site 0502)
  • Fresenius Kidney Care Brookhaven ( Site 0693)
  • Clinical Research Consultants, LLC ( Site 0542)
  • Somnos Clinical Research ( Site 0669)
  • DaVita Five Star Dialysis Center ( Site 0509)
  • Renal Medicine Associates ( Site 0690)
  • Capital District Renal Physicians ( Site 0633)
  • Albert Einstein College of Medicine-Department of Medicine-Nephrology Einstein ( Site 0628)
  • DaVita Clinical Researh ( Site 0501)
  • Ridgewood Dialysis Center ( Site 0725)
  • Fresenius Kidney Care - Charlotte ( Site 0686)
  • Durham Nephrology Associates ( Site 0655)
  • East Carolina University-Department of Nephrology & Hypertension ( Site 0663)
  • Kidney and Hypertension Center ( Site 0571)
  • Northeast Clinical Research Center ( Site 0653)
  • Elixia at Clinical Renal Associates ( Site 0677)
  • South Carolina Nephrology & Hypertension Center-Research ( Site 0672)
  • Knoxville Kidney Center ( Site 0689)
  • Renal Disease Research Institute ( Site 0621)
  • DaVita Clinical Research - El Paso ( Site 0505)
  • DaVita Clinical Research - Houston ( Site 0508)
  • Clinical Research Strategies ( Site 0625)
  • Southwest Houston Research ( Site 0649)
  • Texas Institute for Kidney and Endocrine Disorders ( Site 0626)
  • Gamma Medical Research ( Site 0688)
  • DaVita Clinical Research - Norfolk ( Site 0513)
  • DaVita Clinical Research - Milwaukee ( Site 0512)
  • FME Mansilla ( Site 0007)
  • Fresenius Medical Care - Moron ( Site 0008)
  • Fresenius Medical Care - San Fernando ( Site 0013)
  • CEREHA ( Site 0004)
  • Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0010)
  • Fresenius Medical Care Ciudad Evita ( Site 0006)
  • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0001)
  • Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054)
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
  • Fresenius Clinical Trials Perdizes ( Site 0101)
  • Hospital do Rim e Hipertensão ( Site 0106)
  • Multiprofile Hospital for Active Treatment - "Dr. Cherven Bryag"-Department of dialysis treatment (
  • MHAT Dobrich-Department for dialysis treatment ( Site 0161)
  • First Dialysis Services Bulgaria ( Site 0158)
  • UMBAL Plovdiv AD-Deparment of Hemodialysis ( Site 0162)
  • Hemomed ( Site 0159)
  • University Of Alberta Hospital ( Site 1001)
  • Toronto General Hospital ( Site 1002)
  • Fresenius Medical Care - Dialyzační středisko ( Site 0254)
  • Dialýza ( Site 0256)
  • Fresenius Medical Care ( Site 0253)
  • DaVita Clinical Research Germany GmbH ( Site 0901)
  • ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Sit
  • Ippokrateio General Hospital of Thessaloniki ( Site 1053)
  • G. Papanikolaou General Hospital-Nephrology Department ( Site 1052)
  • P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO ( Site 0954)
  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0953)
  • Fondazione Salvatore Maugeri clinica del lavoro ( Site 0955)
  • Fresenius Medical Care - NephroCare Covilha ( Site 0852)
  • Fresenius Medical Care - Nephrocare Portimao ( Site 0855)
  • Fresenius Medical Care - NephroCare Amadora ( Site 0851)
  • Fresenius Medical Care - NephroCare Almada ( Site 0854)
  • Dyalisis Center - Clinic NephroCare Lumiar -Fresenius ( Site 0853)
  • Fresenius Medical Care Humacao ( Site 0354)
  • Fresenius Nephrocare - Brașov ( Site 0409)
  • Fresenius Nephrocare - Bucharest ( Site 0408)
  • Fresenius Nephrocare - Cluj-Napoca ( Site 0410)
  • Fresenius Nephrocare - Iași ( Site 0406)
  • Unipharm LLC ( Site 0804)
  • Limited Liability Company -Nefroline-Novosibirsk ( Site 0810)
  • Skånes Universitetssjukhus Malmö ( Site 0454)
  • Karolinska Universitetssjukhuset Huddinge-ME Njurmedicin ( Site 0451)
  • Akademiska sjukhuset-Njurmottagningen ( Site 0453)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

MK-2060 Low Dose

MK-2060 High Dose

Placebo

Arm Description

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 administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then QW after week 1

Placebo (normal saline) administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 26, 2021
Last Updated
September 22, 2023
Sponsor
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05027074
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 17, 2021 (Actual)
Primary Completion Date
July 10, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
489 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MK-2060 Low Dose
Arm Type
Experimental
Arm Description
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
Arm Title
MK-2060 High Dose
Arm Type
Experimental
Arm Description
MK-2060 high dose administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then QW after week 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (normal saline) administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1
Intervention Type
Drug
Intervention Name(s)
MK-2060
Intervention Description
MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal saline administered via IV infusion
Primary Outcome Measure Information:
Title
Time to First AVG Thrombosis Event
Description
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).
Time Frame
From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 34 months
Secondary Outcome Measure Information:
Title
Time to Each Arteriovenous Graft Thrombosis Event (First and Recurrent)
Description
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.
Time Frame
Up to approximately 34 months
Title
Number of Participants who Experience One or More Adverse Events (AEs)
Description
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.
Time Frame
Up to approximately 37 months
Title
Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria
Description
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 Frame
Up to approximately 37 months
Title
Number of Participants Who Discontinue Study Intervention Due to an AE
Description
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.
Time Frame
Up to approximately 34 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Nephrology Consultants ( Site 0681)
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85035
Country
United States
Facility Name
AKDHC Medical Research Services, LLC ( Site 0629)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562)
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547)
City
Bakersfield
State/Province
California
ZIP/Postal Code
93304
Country
United States
Facility Name
Fresenius Kidney Care Bakersfield Northeast ( Site 0647)
City
Bakersfield
State/Province
California
ZIP/Postal Code
93306
Country
United States
Facility Name
Fresenius Kidney Care Meadows Field ( Site 0618)
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Facility Name
California Institute Of Renal Research ( Site 0660)
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Citrus Dialysis Center ( Site 0609)
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
California Institute Of Renal Research ( Site 0679)
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
California Institute of Renal Research ( Site 0566)
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
Facility Name
Fresenius Kidney Care Newhope Fountain Valley ( Site 0617)
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
DaVita Glendale Heights ( Site 0604)
City
Glendale
State/Province
California
ZIP/Postal Code
91201
Country
United States
Facility Name
DaVita West Glendale Dialysis ( Site 0579)
City
Glendale
State/Province
California
ZIP/Postal Code
91205
Country
United States
Facility Name
DaVita North Glendale ( Site 0552)
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
California Institute of Renal Research - La Mesa ( Site 0682)
City
La Mesa
State/Province
California
ZIP/Postal Code
91941
Country
United States
Facility Name
La Puente Dialysis Center ( Site 0610)
City
La Puente
State/Province
California
ZIP/Postal Code
91744
Country
United States
Facility Name
Academic Medical Research Institute ( Site 0533)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90022
Country
United States
Facility Name
DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
DaVita Crescent Heights Dialysis Center ( Site 0574)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
North America Research Institute ( Site 0587)
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
North America Research Institute ( Site 0612)
City
Lynwood
State/Province
California
ZIP/Postal Code
90262
Country
United States
Facility Name
Valley Renal Medical Group Research-Clinical Research ( Site 0651)
City
Northridge
State/Province
California
ZIP/Postal Code
91343
Country
United States
Facility Name
California Institute of Renal Research - Kearny Mesa ( Site 0678)
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
North America Research Institute ( Site 0611)
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
DaVita Van Nuys Dialysis ( Site 0538)
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
Desert Cities Diaylsis-Clinical Research ( Site 0615)
City
Victorville
State/Province
California
ZIP/Postal Code
92392
Country
United States
Facility Name
DaVita Clinical Research - Hartford ( Site 0507)
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States
Facility Name
DaVita Clinical Research - Middlebury ( Site 0511)
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Research Physicians Network Alliance ( Site 0563)
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Horizon Research Group ( Site 0578)
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Horizon Research Group ( Site 0581)
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Elixia at Florida Kidney Physicians - Southeast ( Site 0602)
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
South Florida Research Institute ( Site 0656)
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33313
Country
United States
Facility Name
Elixia Clinical Research Collaborative (CRC) - Southeast Florida ( Site 0728)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33020
Country
United States
Facility Name
Pines Clinical Research ( Site 0605)
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Floridian Clinical Research, LLC ( Site 0684)
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Omega Research Orlando ( Site 0645)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Facility Name
Genesis Clinical Research, LLC ( Site 0585)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Genesis Clinical Research, LLC ( Site 0594)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Genesis Clinical Research, LLC ( Site 0680)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
DaVita Clinical Research - Columbus ( Site 0532)
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Renal Physicians of Georgia ( Site 0577)
City
Macon
State/Province
Georgia
ZIP/Postal Code
31217
Country
United States
Facility Name
DaVita East Georgia Dialysis Unit ( Site 0536)
City
Statesboro
State/Province
Georgia
ZIP/Postal Code
30458
Country
United States
Facility Name
University of Chicago Medical Center-Medicine - Section of Nephrology ( Site 0595)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Nephrology Specialists - Merrillville ( Site 0537)
City
Merrillville
State/Province
Indiana
ZIP/Postal Code
46410
Country
United States
Facility Name
Nephrology Specialists - Michigan City ( Site 0541)
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Capital Nephrology ( Site 0596)
City
Greenbelt
State/Province
Maryland
ZIP/Postal Code
20770
Country
United States
Facility Name
Henry Ford Hospital-Nephrology and Hypertension ( Site 0694)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. Clair Nephrology Research - Roseville ( Site 0597)
City
Roseville
State/Province
Michigan
ZIP/Postal Code
48066
Country
United States
Facility Name
DaVita Clinical Research ( Site 0502)
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Fresenius Kidney Care Brookhaven ( Site 0693)
City
Brookhaven
State/Province
Mississippi
ZIP/Postal Code
39601
Country
United States
Facility Name
Clinical Research Consultants, LLC ( Site 0542)
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Somnos Clinical Research ( Site 0669)
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Facility Name
DaVita Five Star Dialysis Center ( Site 0509)
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Renal Medicine Associates ( Site 0690)
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Capital District Renal Physicians ( Site 0633)
City
Albany
State/Province
New York
ZIP/Postal Code
12209
Country
United States
Facility Name
Albert Einstein College of Medicine-Department of Medicine-Nephrology Einstein ( Site 0628)
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
DaVita Clinical Researh ( Site 0501)
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Ridgewood Dialysis Center ( Site 0725)
City
Ridgewood
State/Province
New York
ZIP/Postal Code
11385
Country
United States
Facility Name
Fresenius Kidney Care - Charlotte ( Site 0686)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
Durham Nephrology Associates ( Site 0655)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
East Carolina University-Department of Nephrology & Hypertension ( Site 0663)
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Kidney and Hypertension Center ( Site 0571)
City
Roseburg
State/Province
Oregon
ZIP/Postal Code
97471
Country
United States
Facility Name
Northeast Clinical Research Center ( Site 0653)
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Elixia at Clinical Renal Associates ( Site 0677)
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
South Carolina Nephrology & Hypertension Center-Research ( Site 0672)
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Knoxville Kidney Center ( Site 0689)
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
Renal Disease Research Institute ( Site 0621)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
DaVita Clinical Research - El Paso ( Site 0505)
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
DaVita Clinical Research - Houston ( Site 0508)
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Clinical Research Strategies ( Site 0625)
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Southwest Houston Research ( Site 0649)
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Texas Institute for Kidney and Endocrine Disorders ( Site 0626)
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Gamma Medical Research ( Site 0688)
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
DaVita Clinical Research - Norfolk ( Site 0513)
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
DaVita Clinical Research - Milwaukee ( Site 0512)
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
FME Mansilla ( Site 0007)
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1425BPM
Country
Argentina
Facility Name
Fresenius Medical Care - Moron ( Site 0008)
City
Morón
State/Province
Buenos Aires
ZIP/Postal Code
B1708DPO
Country
Argentina
Facility Name
Fresenius Medical Care - San Fernando ( Site 0013)
City
San Fernando
State/Province
Buenos Aires
ZIP/Postal Code
1646
Country
Argentina
Facility Name
CEREHA ( Site 0004)
City
Sarandi
State/Province
Buenos Aires
ZIP/Postal Code
B1872JBA
Country
Argentina
Facility Name
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 0010)
City
Ciudad Autónoma de Buenos Aires
State/Province
Caba
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Fresenius Medical Care Ciudad Evita ( Site 0006)
City
Buenos Aires
ZIP/Postal Code
B1778IFA
Country
Argentina
Facility Name
Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0001)
City
Santa Fe
ZIP/Postal Code
3000
Country
Argentina
Facility Name
Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054)
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site
City
São José do Rio Preto
State/Province
Sao Paulo
ZIP/Postal Code
15090000
Country
Brazil
Facility Name
Fresenius Clinical Trials Perdizes ( Site 0101)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
05024-030
Country
Brazil
Facility Name
Hospital do Rim e Hipertensão ( Site 0106)
City
Sao Paulo
ZIP/Postal Code
04038-002
Country
Brazil
Facility Name
Multiprofile Hospital for Active Treatment - "Dr. Cherven Bryag"-Department of dialysis treatment (
City
Cherven bryag
State/Province
Lovech
ZIP/Postal Code
5980
Country
Bulgaria
Facility Name
MHAT Dobrich-Department for dialysis treatment ( Site 0161)
City
Dobrich
ZIP/Postal Code
9300
Country
Bulgaria
Facility Name
First Dialysis Services Bulgaria ( Site 0158)
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Facility Name
UMBAL Plovdiv AD-Deparment of Hemodialysis ( Site 0162)
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Hemomed ( Site 0159)
City
Sofia
ZIP/Postal Code
1618
Country
Bulgaria
Facility Name
University Of Alberta Hospital ( Site 1001)
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Toronto General Hospital ( Site 1002)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Fresenius Medical Care - Dialyzační středisko ( Site 0254)
City
Prague
State/Province
Praha 4
ZIP/Postal Code
142 00
Country
Czechia
Facility Name
Dialýza ( Site 0256)
City
Beroun
ZIP/Postal Code
266 01
Country
Czechia
Facility Name
Fresenius Medical Care ( Site 0253)
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
DaVita Clinical Research Germany GmbH ( Site 0901)
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40210
Country
Germany
Facility Name
ATTIKON GENERAL UNIVERSITY HOSPITAL-2nd Dep. of Int. Medicine. Research Unit & Diabetes Center ( Sit
City
Chaidari
State/Province
Attiki
ZIP/Postal Code
124 62
Country
Greece
Facility Name
Ippokrateio General Hospital of Thessaloniki ( Site 1053)
City
Thessaloniki
State/Province
Kentriki Makedonia
ZIP/Postal Code
546 42
Country
Greece
Facility Name
G. Papanikolaou General Hospital-Nephrology Department ( Site 1052)
City
Thessaloniki
ZIP/Postal Code
570 10
Country
Greece
Facility Name
P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO ( Site 0954)
City
Milan
State/Province
Milano
ZIP/Postal Code
20153
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda ( Site 0953)
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
Fondazione Salvatore Maugeri clinica del lavoro ( Site 0955)
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Fresenius Medical Care - NephroCare Covilha ( Site 0852)
City
Covilhã
State/Province
Castelo Branco
ZIP/Postal Code
6200-000
Country
Portugal
Facility Name
Fresenius Medical Care - Nephrocare Portimao ( Site 0855)
City
Portimão
State/Province
Faro
ZIP/Postal Code
8500-311
Country
Portugal
Facility Name
Fresenius Medical Care - NephroCare Amadora ( Site 0851)
City
Amadora
State/Province
Lisboa
ZIP/Postal Code
2700-391
Country
Portugal
Facility Name
Fresenius Medical Care - NephroCare Almada ( Site 0854)
City
Corroios
State/Province
Lisboa
ZIP/Postal Code
2855-227
Country
Portugal
Facility Name
Dyalisis Center - Clinic NephroCare Lumiar -Fresenius ( Site 0853)
City
Lisbon
State/Province
Lisboa
ZIP/Postal Code
1750-130
Country
Portugal
Facility Name
Fresenius Medical Care Humacao ( Site 0354)
City
Humacao
ZIP/Postal Code
00971
Country
Puerto Rico
Facility Name
Fresenius Nephrocare - Brașov ( Site 0409)
City
Brașov
State/Province
Braila
ZIP/Postal Code
500152
Country
Romania
Facility Name
Fresenius Nephrocare - Bucharest ( Site 0408)
City
Bucharest
State/Province
Bucuresti
ZIP/Postal Code
013217
Country
Romania
Facility Name
Fresenius Nephrocare - Cluj-Napoca ( Site 0410)
City
Cluj-Napoca
State/Province
Cluj
ZIP/Postal Code
400528
Country
Romania
Facility Name
Fresenius Nephrocare - Iași ( Site 0406)
City
Iași
State/Province
Iasi
ZIP/Postal Code
700523
Country
Romania
Facility Name
Unipharm LLC ( Site 0804)
City
Krasnogorsk
State/Province
Moskovskaya Oblast
ZIP/Postal Code
143403
Country
Russian Federation
Facility Name
Limited Liability Company -Nefroline-Novosibirsk ( Site 0810)
City
Novosibirsk
State/Province
Novosibirskaya Oblast
ZIP/Postal Code
630064
Country
Russian Federation
Facility Name
Skånes Universitetssjukhus Malmö ( Site 0454)
City
Malmö
State/Province
Skane Lan
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Karolinska Universitetssjukhuset Huddinge-ME Njurmedicin ( Site 0451)
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Akademiska sjukhuset-Njurmottagningen ( Site 0453)
City
Uppsala
State/Province
Uppsala Lan
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Links:
URL
https://www.merckclinicaltrials.com/
Description
Merck Clinical Trials Information

Learn more about this trial

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)

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