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)

Purpose

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.

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Active, not recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact