NCT05027074

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)

A Randomized Parallel-group, Placebo-controlled, Double-blind, Event-driven, Multi-center Phase 2 Clinical Outcome Trial of Prevention of Arteriovenous Graft Thrombosis and Safety of MK-2060 in Patients With End Stage Renal Disease Receiving Hemodialysis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 506 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	MK-2060	MK-2060 lyophilized powder diluted in normal saline and administered via IV infusion
DRUG	Placebo	Normal saline administered via IV infusion

Timeline

• Start date: 2021-09-17
• Primary completion: 2024-10-30
• Completion: 2025-02-13
• First posted: 2021-08-30
• Last updated: 2026-02-11
• Results posted: 2025-11-17

Locations

120 sites across 15 countries: United States, Argentina, Australia, Brazil, Bulgaria, Canada, Czechia, Germany, Greece, Italy, Portugal, Puerto Rico, Romania, Russia, Sweden

Regulatory

• FDA-regulated drug study