What side effects are associated with this type of intervention?

Common treatments for kidney failure, especially those involving monoclonal antibodies like MK-2060, often include medications to manage symptoms and prevent complications. Known side effects of these treatments can include infusion reactions, increased risk of infections, and potential for serious adverse events such as pancytopenia and renal toxicity. Other side effects may include gastrointestinal distress, fatigue, and hypertension. It is crucial for patients to be closely monitored by their healthcare providers to manage these risks effectively.

What prior FDA approvals exist?

The FDA has approved various treatments for kidney failure, including medications and therapies targeting different pathways. While specific monoclonal antibodies like MK-2060 (anti-Factor XI) are still under investigation, other treatments such as erythropoiesis-stimulating agents (e.g., epoetin alfa) and phosphate binders (e.g., sevelamer) are commonly used. Additionally, immunosuppressive drugs like rituximab, a monoclonal antibody, have been used in certain kidney conditions such as ANCA-associated vasculitis. Broader treatment strategies for kidney failure also include dialysis and kidney transplantation.

What other types of research exist?

Promising alternatives to MK-2060 for kidney failure patients include low molecular weight heparins (e.g., FR-860), which have shown higher efficacy and safety compared to unfractionated heparin in hemodialysis models. Additionally, PAI-1-resistant t-PA has demonstrated effectiveness in preventing fibrin deposition in models with increased PAI-1 activity, which could be beneficial in managing coagulation issues in kidney failure patients.

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Monoclonal Antibody

Anti-Factor XI Monoclonal Antibody for Kidney Failure

Q: What is the mechanism of action of this treatment?

Common treatments for kidney failure include dialysis, medications like ACE inhibitors or ARBs, and emerging therapies such as monoclonal antibodies. Dialysis mechanically filters waste from the blood, while ACE inhibitors and ARBs manage blood pressure and reduce proteinuria. Monoclonal antibodies like MK-2060, which target Factor XI to reduce clot formation, are particularly relevant for kidney failure patients undergoing hemodialysis, as they help mitigate the high risk of clot-related complications. These treatments are crucial for managing symptoms, preventing complications, and slowing the progression of kidney disease.

Phase 2

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Current diagnosis of ESRD

Must not have

Planning on receiving an arteriovenous fistula (AVF) placement within 12 months

Recent hemorrhagic stroke or lacunar stroke (<1 month)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 37 months

Summary

This trial is testing MK-2060, a medicine that blocks a blood protein, on patients with severe kidney disease. The goal is to see if it can prevent clots and keep the treatment method effective for a longer period.

Who is the study for?

This trial is for adults with end-stage renal disease (ESRD) who are on hemodialysis through an arteriovenous graft. Participants must not be pregnant, agree to contraception if of childbearing potential, and have had stable dialysis sessions. Exclusions include recent cancer or strokes, recurrent bleeding episodes, substance abuse history, and those on certain blood thinners.

What is being tested?

The study tests two doses of MK-2060 (an antibody targeting clotting Factor XI) against a placebo in ESRD patients undergoing hemodialysis. The goal is to find the better dose for preventing complications related to the dialysis access point by comparing how long it takes for issues to arise.

What are the potential side effects?

Potential side effects may include bleeding events due to MK-2060's effect on blood clotting processes. Since this medication targets a specific part of the clotting mechanism, there could also be risks associated with immune reactions or infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am on hemodialysis at least 3 times a week for 3 hours each, through a working graft.

Select...

I have end-stage renal disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I plan to get an AVF placement within the next year.

Select...

I have not had a bleeding stroke or a small vessel stroke in the last month.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 37 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 37 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 37 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Thrombosis

Secondary study objectives

Hemorrhage

Number of Participants Who Discontinue Study Intervention Due to an AE

Number of Participants who Experience One or More Adverse Events (AEs)

+1 more

Side effects data

From 2021 Phase 1 trial • 38 Patients • NCT03873038

Myocardial infarction

Nausea

Sneezing

100%

80%

60%

40%

20%

Study treatment Arm

Part 2: MK-2060 25-mg Loading/ 25-mg Maintenance

Part 1: Panel A- MK-2060 (8 mg)

Part 2: Placebo

Part 1: Panel B- MK-2060 (20 mg)

Part 1: Panel C- MK-2060 (40 mg)

Part 1: Placebo

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: MK-2060 Low DoseExperimental Treatment1 Intervention

MK-2060 low dose administered via intravenous (IV) infusion as a loading dose: Every other day (QOD) during week 1 (3 administrations), then once a week (QW) after week 1

Group II: MK-2060 High DoseExperimental Treatment1 Intervention

MK-2060 high dose administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then QW after week 1

Group III: PlaceboPlacebo Group1 Intervention

Placebo (normal saline) administered via IV infusion as a loading dose: QOD during week 1 (3 administrations), then once a week after week 1

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-2060

2019

Completed Phase 1

~90

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for kidney failure include dialysis, medications like ACE inhibitors or ARBs, and emerging therapies such as monoclonal antibodies. Dialysis mechanically filters waste from the blood, while ACE inhibitors and ARBs manage blood pressure and reduce proteinuria. Monoclonal antibodies like MK-2060, which target Factor XI to reduce clot formation, are particularly relevant for kidney failure patients undergoing hemodialysis, as they help mitigate the high risk of clot-related complications. These treatments are crucial for managing symptoms, preventing complications, and slowing the progression of kidney disease.

Effect of low-dose atrial natriuretic peptide in critically ill patients with acute kidney injury: a retrospective, single-center study with propensity-score matching.