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)

Phase 2

Completed

• Conditions: Kidney Failure, Chronic; End-Stage Renal Disease; End-Stage Kidney Disease
• Interventions: Drug: Placebo; Drug: MK-2060

• Registration Number: NCT05027074
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-26
• Study First Submitted QC: 2021-08-26
• Study First Posted: 2021-08-30
• Study Start: 2021-09-17
• Primary Completion: 2024-10-30
• Status Verified: 2025-02
• Study Completion: 2025-02-13
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 506

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 34 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

Name	Time	Method
Number of Participants who Experience One or More Adverse Events (AEs)	Up to approximately 37 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.
Number of Participants Who Discontinue Study Intervention Due to an AE	Up to approximately 34 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.
Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria	Up to approximately 37 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.
Time to Each Arteriovenous Graft Thrombosis Event (First and Recurrent)	Up to approximately 34 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.

Trial Locations

Locations (120)

Nephrology Consultants ( Site 0681); 🇺🇸 Huntsville, Alabama, United States

AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723); 🇺🇸 Phoenix, Arizona, United States

AKDHC Medical Research Services, LLC ( Site 0629); 🇺🇸 Tucson, Arizona, 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

California Institute Of Renal Research ( Site 0660); 🇺🇸 Chula Vista, California, United States

Citrus Dialysis Center ( Site 0609); 🇺🇸 Covina, California, United States

California Institute Of Renal Research ( Site 0679); 🇺🇸 El Centro, California, United States

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