Anti-Factor XI Monoclonal Antibody for Kidney Failure

This trial tests a new treatment called MK-2060, a monoclonal antibody designed to assist people with end-stage renal disease (ESRD) undergoing hemodialysis. The goal is to determine if two different doses of MK-2060 can safely and effectively delay complications with the arteriovenous graft (AVG), a special connection used for dialysis. Participants will receive either a high dose, a low dose, or a placebo for comparison. Those who have been on regular hemodialysis with a well-functioning AVG for at least four weeks may be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

The trial requires that you do not take anticoagulants or antiplatelet medications, except for heparin during dialysis and aspirin. If you are on other blood thinners, you may need to stop them.

Research has shown that MK-2060, a monoclonal antibody, is under evaluation for safety and effectiveness in people with end-stage kidney disease. Earlier studies found that MK-2060 does not significantly increase bleeding risk in these patients, suggesting it might be well-tolerated. Additionally, no reports of serious side effects have been directly linked to MK-2060 in the available research. The current study is in the middle stages of clinical trials, indicating that early safety results are positive, but further research is needed to confirm these findings.¹²³⁴⁵

Researchers are excited about MK-2060 for kidney failure because it targets Factor XI, a key component in blood clot formation, using a monoclonal antibody approach. Unlike standard treatments that might focus on managing symptoms or other pathways, MK-2060 directly interrupts the coagulation cascade, potentially reducing the risk of blood clots without the same bleeding risks associated with traditional anticoagulants. Additionally, the treatment is administered via intravenous infusion, which might offer a controlled delivery method compared to oral medications, ensuring precise dosing and potentially improving outcomes.

Research has shown that MK-2060, a type of antibody, has not significantly reduced blood clots in patients with severe kidney disease on dialysis. In this trial, participants will receive either a high dose or low dose of MK-2060, or a placebo. Studies comparing MK-2060 to a placebo found it ineffective in preventing clots in the blood vessels used for dialysis. While researchers are studying MK-2060 for its potential to prevent blood clots, current evidence does not support its effectiveness for this purpose. Ongoing research aims to better understand its role and possible benefits.¹²³⁴⁵