Anti-Factor XI Monoclonal Antibody for Kidney Failure

Recruiting at 124 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Cancer, Heart valve, Stroke, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: Up to approximately 34 months

506 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am not pregnant, breastfeeding, and if capable of bearing children, I agree to use contraception during and after the study.

I have end-stage renal disease.

Exclusion Criteria

I am taking or will take blood thinners, except for heparin during dialysis and aspirin.

Recent history (<1 year) of drug or alcohol abuse or dependence

I have not had recent severe bleeding or a history of frequent bleeding in the past 2 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MK-2060 or placebo via IV infusion with a loading dose every other day during week 1, then once a week after week 1

Up to approximately 34 months

3 visits (in-person) during week 1, then weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring for adverse events and bleeding events

Up to approximately 37 months

What Are the Treatments Tested in This Trial?

Interventions

• MK-2060

Trial Overview 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.

How Is the Trial Designed?

Group I: MK-2060 Low Dose Experimental Treatment 1 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 Dose Experimental Treatment 1 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: Placebo Placebo Group 1 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

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University