Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (Factor XI Hemodialysis Study) (MK-2060-007)

• Status: Recruiting
• Trial end date: 2023-04-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.

Criteria

Inclusion Criteria:

• Current diagnosis of ESRD.

• Receiving hemodialysis ≥3 times per week with each hemodialysis session being a minimum of 3 hours duration via a normally functioning, uninfected AVG for at least 4 weeks.

• 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.

• 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.