Factor XI inhibition is not useful for end-stage kidney disease patients receiving haemodialysis

In a phase 2 trial, factor XI inhibition with MK-2060 did not improve arteriovenous graft thrombotic events compared with placebo in patients with end-stage kidney disease undergoing haemodialysis via an arteriovenous graft, but increased bleeding events.

Prof. Wolfgang Winkelmayer (Baylor College of Medicine, TX, USA) presented results from a randomised, placebo-controlled, double-blind, phase 2 trial (NCT05027074) investigating MK-2060, a monoclonal antibody targeted at factor XI [1]. Patients were eligible if they had end-stage kidney disease and received haemodialysis via an arteriovenous graft, and had haemodialysis or haemodiafiltration at least 3 times/week for at least 3 h/session. The 506 participants were randomised 1:1:1 to either intravenous MK-2060 20 mg every week, MK-2060 6 mg every week, or a matching placebo. The primary endpoint was time-to-first arteriovenous graft thrombotic event.

Overall, the trial did not meet its primary endpoint. After a median follow-up of 16.6 months, the number of events was lower with both MK-2060 20 mg every week (23.80 events/100 patient-years) and MK-2060 6 mg every week (22.98 events/100 patient-years) versus placebo (30.17 events/100 patient-years), but these results were not significant. Furthermore, there were no signals of efficacy in the secondary endpoint of first and recurrent arteriovenous graft thrombosis event, or the exploratory endpoint of time-to-first major cardiovascular event. However, there was a trend for increased major or clinically relevant non-major bleeding events with both MK-2060 doses versus placebo, with vascular access bleeding as the most common cause of non-major bleeding.

“In this phase 2 trial in patients with end-stage kidney disease requiring haemodialysis via an arteriovenous graft, MK-2060 did not significantly reduce time-to-arteriovenous graft thrombosis versus placebo,” concluded Prof. Winkelmayer. “MK-2060 was associated with increased bleeding risk, mostly driven by non-serious vascular access bleeding. Further research is perhaps needed to understand how factor XI inhibition can be useful in patients with end-stage kidney disease requiring haemodialysis.”

1. Winkelmayer W, et al. A phase 2b trial of efficacy and safety of factor XI inhibition with MK-2060 for preventing arteriovenous graft thrombosis in haemodialysis patients. 62nd ERA Congress, 4–7 June 2025, Vienna, Austria.

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Posted on 22 August 202525 August 2025