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)

Merck Sharp & Dohme (MSD)

Status and phase: Active, not recruiting; Phase 2

Conditions: End-Stage Renal Disease; End-Stage Kidney Disease; Kidney Failure, Chronic

Treatments: Drug: MK-2060; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05027074

2020-002397-27 (EudraCT Number)

MK-2060-007 (Other Identifier)

2060-007

Details and patient eligibility

About

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.

Enrollment: 489 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

489 participants in 3 patient groups, including a placebo group

MK-2060 Low Dose

Experimental group

Description:

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

Treatment:

Drug: MK-2060

MK-2060 High Dose

Experimental group

Description:

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

Treatment:

Drug: MK-2060

Placebo

Placebo Comparator group

Description:

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:

Drug: Placebo