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)

Sponsor
Merck Sharp & Dohme LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05027074
Collaborator
(none)
489
96
3
19
5.1
0.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
489 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Sep 17, 2021
Anticipated Primary Completion Date :
Mar 27, 2023
Anticipated Study Completion Date :
Apr 18, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: MK-2060 Low Dose

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

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

Experimental: MK-2060 High Dose

MK-2060 high dose administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then QW after week 1

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

Placebo Comparator: 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

Drug: Placebo
Normal saline administered via IV infusion

Outcome Measures

Primary Outcome Measures

  1. 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 17 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

  1. Number of AVG Thrombosis Events [Up to approximately 17 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.

  2. Number of Participants who Experience One or More Adverse Events (AEs) [Up to approximately 20 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.

  3. Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria [Up to approximately 20 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.

  4. Number of Participants Who Discontinue Study Intervention Due to an AE [Up to approximately 17 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nephrology Consultants ( Site 0681) Huntsville Alabama United States 35805
2 AKDHC Medical Research Services, LLC ( Site 0629) Tucson Arizona United States 85741
3 DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562) Anaheim California United States 92801
4 DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547) Bakersfield California United States 93304
5 Fresenius Kidney Care Meadows Field ( Site 0618) Bakersfield California United States 93308
6 Fresenius Kidney Care Bakersfield ( Site 0647) Bakersfield California United States 93311
7 California Institute Of Renal Research ( Site 0660) Chula Vista California United States 91910
8 Citrus Dialysis Center ( Site 0609) Covina California United States 91723
9 California Institute of Renal Research ( Site 0566) Escondido California United States 92025
10 Fresenius Kidney Care Newhope Fountain Valley ( Site 0617) Fountain Valley California United States 92708
11 DaVita Glendale Heights ( Site 0604) Glendale California United States 91201
12 DaVita West Glendale Dialysis ( Site 0579) Glendale California United States 91205
13 DaVita North Glendale ( Site 0552) Glendale California United States 91206
14 California Institute of Renal Research - La Mesa ( Site 0682) La Mesa California United States 91941
15 La Puente Dialysis Center ( Site 0610) La Puente California United States 91744
16 Academic Medical Research Institute ( Site 0533) Los Angeles California United States 90022
17 DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548) Los Angeles California United States 90033
18 DaVita Crescent Heights Dialysis Center ( Site 0574) Los Angeles California United States 90048
19 North America Research Institute ( Site 0587) Lynwood California United States 90262
20 North America Research Institute ( Site 0612) Lynwood California United States 90262
21 Valley Renal Medical Group Research-Clinical Research ( Site 0651) Northridge California United States 91343
22 California Institute of Renal Research - Kearny Mesa ( Site 0678) San Diego California United States 92111
23 North America Research Institute ( Site 0611) San Dimas California United States 91773
24 DaVita Van Nuys Dialysis ( Site 0538) Van Nuys California United States 91405
25 Desert Cities Diaylsis-Clinical Research ( Site 0615) Victorville California United States 92392
26 DaVita Clinical Research - Hartford ( Site 0507) Hartford Connecticut United States 06112
27 DaVita Clinical Research - Middlebury ( Site 0511) Middlebury Connecticut United States 06762
28 Research Physicians Network Alliance ( Site 0563) Boca Raton Florida United States 33431
29 Horizon Research Group ( Site 0578) Coral Gables Florida United States 33134
30 Horizon Research Group ( Site 0581) Coral Gables Florida United States 33134
31 Elixia at Florida Kidney Physicians - Southeast ( Site 0602) Fort Lauderdale Florida United States 33308
32 South Florida Research Institute ( Site 0656) Fort Lauderdale Florida United States 33313
33 Pines Clinical Research ( Site 0605) Hollywood Florida United States 33024
34 Floridian Clinical Research, LLC ( Site 0684) Miami Lakes Florida United States 33016
35 Omega Research MetroWest ( Site 0645) Orlando Florida United States 32835
36 Genesis Clinical Research ( Site 0585) Tampa Florida United States 33603
37 Genesis Clinical Research ( Site 0594) Tampa Florida United States 33603
38 Genesis Clinical Research ( Site 0680) Tampa Florida United States 33603
39 DaVita Clinical Research - Columbus ( Site 0532) Columbus Georgia United States 31904
40 Renal Physicians of Georgia ( Site 0577) Macon Georgia United States 31217
41 DaVita East Georgia Dialysis Unit ( Site 0536) Statesboro Georgia United States 30458
42 University of Chicago Medical Center-Medicine - Section of Nephrology ( Site 0595) Chicago Illinois United States 60637
43 Nephrology Specialists - Merrillville ( Site 0537) Merrillville Indiana United States 46410
44 Nephrology Specialists - Michigan City ( Site 0541) Michigan City Indiana United States 46360
45 Capital Nephrology ( Site 0596) Greenbelt Maryland United States 20770
46 Henry Ford Hospital-Nephrology and Hypertension ( Site 0694) Detroit Michigan United States 48202
47 St. Clair Nephrology Research - Roseville ( Site 0597) Roseville Michigan United States 48066
48 DaVita Clinical Research ( Site 0502) Minneapolis Minnesota United States 55404
49 Fresenius Kidney Care Brookhaven ( Site 0693) Brookhaven Mississippi United States 39601
50 Clinical Research Consultants, LLC ( Site 0542) Kansas City Missouri United States 64111
51 Somnos Clinical Research ( Site 0669) Lincoln Nebraska United States 68510
52 DaVita Five Star Dialysis Center ( Site 0509) Las Vegas Nevada United States 89128
53 Renal Medicine Associates ( Site 0690) Albuquerque New Mexico United States 87109
54 Albert Einstein College of Medicine-Department of Medicine-Nephrology Einstein ( Site 0628) Bronx New York United States 10461
55 DaVita Clinical Researh ( Site 0501) Bronx New York United States 10461
56 Fresenius Kidney Care - Charlotte ( Site 0686) Charlotte North Carolina United States 28204
57 Durham Nephrology Associates ( Site 0655) Durham North Carolina United States 27704
58 East Carolina University-Department of Nephrology & Hypertension ( Site 0663) Greenville North Carolina United States 27834
59 Kidney and Hypertension Center ( Site 0571) Roseburg Oregon United States 97471
60 Northeast Clinical Research Center ( Site 0653) Bethlehem Pennsylvania United States 18017
61 South Carolina Nephrology & Hypertension Center-Research ( Site 0672) Orangeburg South Carolina United States 29118
62 Knoxville Kidney Center ( Site 0689) Knoxville Tennessee United States 37923
63 Renal Disease Research Institute ( Site 0621) Dallas Texas United States 75204
64 DaVita Clinical Research - El Paso ( Site 0505) El Paso Texas United States 79925
65 DaVita Clinical Research - Houston ( Site 0508) Houston Texas United States 77004
66 Clinical Research Strategies ( Site 0625) Houston Texas United States 77090
67 Southwest Houston Research ( Site 0649) Houston Texas United States 77099
68 Texas Institute for Kidney and Endocrine Disorders ( Site 0626) Lufkin Texas United States 75904
69 Gamma Medical Research ( Site 0688) McAllen Texas United States 78503
70 DaVita Clinical Research - Norfolk ( Site 0513) Norfolk Virginia United States 23502
71 FME Mansilla ( Site 0007) Ciudad Autonoma de Buenos Aires Buenos Aires Argentina C1425BPM
72 Fresenius Medical Care - Moron ( Site 0008) Morón Buenos Aires Argentina B1708DPO
73 CEREHA ( Site 0004) Sarandi Buenos Aires Argentina B1872JBA
74 Fresenius Medical Care Ciudad Evita ( Site 0006) Buenos Aires Argentina B1778IFA
75 Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0001) Santa Fe Argentina S3000BPJ
76 Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054) St Albans Victoria Australia 3021
77 Fundação Faculdade Regional de Medicina de São José do Rio Preto-Centro Integrado de Pesquisa ( Site São José do Rio Preto Sao Paulo Brazil 15090000
78 Multiprofile Hospital for Active Treatment - "Dr. Cherven Bryag"-Department of dialysis treatment ( Cherven bryag Lovech Bulgaria 5980
79 Hemomed ( Site 0159) Sofia Plovdiv Bulgaria 1431
80 MHAT Dobrich-Department for dialysis treatment ( Site 0161) Dobrich Bulgaria 9300
81 First Dialysis Services Bulgaria ( Site 0158) Montana Bulgaria 3400
82 UMBAL Plovdiv AD-Deparment of Hemodialysis ( Site 0162) Plovdiv Bulgaria 4003
83 Fresenius Medical Care - Dialyzační středisko ( Site 0254) Prague Praha 4 Czechia 142 00
84 Dialýza ( Site 0256) Beroun Czechia 266 01
85 Fresenius Medical Care ( Site 0253) Pardubice Czechia 532 03
86 DaVita Clinical Research Germany GmbH ( Site 0901) Düsseldorf Nordrhein-Westfalen Germany 40210
87 ASST Grande Ospedale Metropolitano Niguarda ( Site 0953) Milano Italy 20162
88 Fresenius Medical Care Humacao ( Site 0354) Humacao Puerto Rico 00791
89 Fresenius Nephrocare - Brașov ( Site 0409) Brașov Braila Romania 500152
90 Fresenius Nephrocare - Bucharest ( Site 0408) Bucharest Bucuresti Romania 013217
91 Fresenius Nephrocare - Cluj-Napoca ( Site 0410) Cluj-Napoca Cluj Romania 400528
92 Fresenius Nephrocare - Iași ( Site 0406) Iași Iasi Romania 700523
93 Unipharm LLC ( Site 0804) Krasnogorsk Moskovskaya Oblast Russian Federation 143403
94 Limited Liability Company -Nefroline-Novosibirsk ( Site 0810) Novosibirsk Novosibirskaya Oblast Russian Federation 630064
95 Karolinska Universitetssjukhuset Huddinge-ME Njurmedicin ( Site 0451) Stockholm Stockholms Lan Sweden 141 86
96 Akademiska sjukhuset-Njurmottagningen ( Site 0453) Uppsala Uppsala Lan Sweden 751 85

Sponsors and Collaborators

  • Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:
NCT05027074
Other Study ID Numbers:
  • 2060-007
  • MK-2060-007
  • 2020-002397-27
First Posted:
Aug 30, 2021
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022