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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05027074
Registration number
NCT05027074
Ethics application status
Date submitted
26/08/2021
Date registered
30/08/2021
Date last updated
25/09/2023
Titles & IDs
Public 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)
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Scientific 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
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Secondary ID [1]
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MK-2060-007
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Secondary ID [2]
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2060-007
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
End-Stage Renal Disease
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End-Stage Kidney Disease
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Kidney Failure, Chronic
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Condition category
Condition code
Renal and Urogenital
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MK-2060
Treatment: Drugs - Placebo
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
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
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
Treatment: Drugs: MK-2060
MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion
Treatment: Drugs: Placebo
Normal saline administered via IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to First AVG Thrombosis Event
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Assessment method [1]
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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).
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Timepoint [1]
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From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 34 months
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Secondary outcome [1]
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Time to Each Arteriovenous Graft Thrombosis Event (First and Recurrent)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 34 months
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Secondary outcome [2]
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Number of Participants who Experience One or More Adverse Events (AEs)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 37 months
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Secondary outcome [3]
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Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria
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Assessment method [3]
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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.
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Timepoint [3]
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Up to approximately 37 months
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Secondary outcome [4]
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Number of Participants Who Discontinue Study Intervention Due to an AE
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 34 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
17/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/10/2024
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Actual
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Sample size
Target
489
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054) - St Albans
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Recruitment postcode(s) [1]
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3021 - St Albans
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Recruitment outside Australia
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United States of America
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Alabama
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Moskovskaya Oblast
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05027074
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05027074
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