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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05027074




Registration number
NCT05027074
Ethics application status
Date submitted
26/08/2021
Date registered
30/08/2021

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)
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
Secondary ID [1] 0 0
MK-2060-007
Secondary ID [2] 0 0
2060-007
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End-Stage Renal Disease 0 0
End-Stage Kidney Disease 0 0
Kidney Failure, Chronic 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First AVG Thrombosis Event
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
From date of randomization until the date of first occurrence of an AVG thrombosis event, assessed up to approximately 34 months
Secondary outcome [1] 0 0
Time to Each Arteriovenous Graft Thrombosis Event (First and Recurrent)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to approximately 34 months
Secondary outcome [2] 0 0
Number of Participants who Experience One or More Adverse Events (AEs)
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Up to approximately 37 months
Secondary outcome [3] 0 0
Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
Up to approximately 37 months
Secondary outcome [4] 0 0
Number of Participants Who Discontinue Study Intervention Due to an AE
Assessment method [4] 0 0
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.
Timepoint [4] 0 0
Up to approximately 34 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/02/2025
Sample size
Target
Accrual to date
Final
506
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Western Health-Sunshine & Footscray Hospitals-Renal Services ( Site 0054) - St Albans
Recruitment postcode(s) [1] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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State/province [2] 0 0
Arizona
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California
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Connecticut
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Illinois
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Indiana
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Maryland
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Michigan
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Minnesota
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Mississippi
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Nebraska
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Tennessee
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Caba
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Santa Fe
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Lovech
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Dobrich
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Sofia
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Greece
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Attiki
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Kentriki Makedonia
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Greece
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Thessaloniki
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Milano
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Lisboa
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Humacao
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Braila
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Bucuresti
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Cluj
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Iasi
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Russian Federation
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Moskovskaya Oblast
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Russian Federation
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Novosibirskaya Oblast
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Sweden
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Skane Lan
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Sweden
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Stockholms Lan
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Sweden
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Uppsala Lan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05027074