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)

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.

Timeline

Start

2021-09-17

Primary completion

2024-10-30

Completion

2025-02-13

Outcome

Missed primary endpoint

registry analysis (superiority test); MK-2060 20 mg vs Placebo; p = 0.470; Hazard Ratio (HR) 0.87 (95% CI 0.60 to 1.26); NCT05027074 ↗

Drugs

Indications