Phase 2
Completed N=506
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)
End-Stage Renal Disease · End-Stage Kidney Disease · Kidney Failure, Chronic
Source: ClinicalTrials.gov NCT05027074 ↗
Enrolled (actual)
506
Serious AEs
63.1%
Results posted
Nov 2025
Primary outcomePrimary: Time to First Arteriovenous Graft (AVG) Thrombosis Event — 23.80; 22.98; 30.17 events per 100 person-years — p=0.470
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Arteriovenous Graft (AVG) Thrombosis Event |
23.80; 22.98; 30.17 | 0.470 |
| SECONDARY Time to Each AVG Thrombosis Event (First and Recurrent) |
38.95; 37.85; 42.97 | — |
| SECONDARY Number of Participants Who Experience One or More Adverse Events (AEs) |
161; 143; 155 | — |
| SECONDARY Time to First Event of International Society on Thrombosis (ISTH) Major Bleeding Event or a Clinically Relevant Non-Major Bleeding Event |
24.73; 18.05; 14.04 | 0.022 sig |
| SECONDARY Number of Participants Who Discontinue Study Intervention Due to an AE |
47; 32; 46 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05027074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.