MK-2060 for Kidney Disease

No longer recruiting at 3 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Cancer, Thrombosis, Bleeding disorders, others

Compensation: Varies

Number of Visits: 9

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new treatment called MK-2060, which researchers are studying for its safety and how the body processes it in people with severe kidney disease. Participants will receive either a single dose of MK-2060 or a placebo (a harmless substance with no active treatment) to compare results. The trial seeks individuals with stage 4 chronic kidney disease who do not have a recent history of cancer, blood clots, or major surgeries. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but ongoing anticoagulant or antiplatelet therapy is not allowed, except for aspirin. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that MK-2060 is likely to be safe for humans?

Research has shown that MK-2060 has undergone testing in earlier studies to assess its safety and tolerability. In one study, participants took a single dose of MK-2060, and they tolerated it well, with no serious side effects reported. Another study tested MK-2060 alongside a common medication and also found it to be safe. As this trial is in its first phase, researchers continue to closely monitor the treatment's safety in humans. However, initial findings suggest it is generally safe to use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MK-2060 for kidney disease because it offers a potentially new approach to treatment. Unlike traditional treatments that might focus on managing symptoms or slowing disease progression, MK-2060 is administered as a single subcutaneous dose, which could simplify the treatment process for patients. This new drug may work differently by targeting specific pathways involved in kidney disease, potentially offering a more direct and efficient way to address the condition. This unique method of delivery and action sets MK-2060 apart from current options, and it's this potential for improved outcomes that has researchers hopeful.

What evidence suggests that MK-2060 might be an effective treatment for kidney disease?

Research shows that MK-2060 is a new treatment under development to prevent blood clots in people with kidney disease. It blocks Factor XI, which aids in blood clotting. Studies have shown that MK-2060 holds promise in reducing clotting events in kidney disease patients on dialysis. However, some research suggests it may not significantly reduce certain types of clots, such as those related to the arteriovenous grafts used in dialysis. As it is still early, more research is needed to fully understand its effectiveness. Participants in this trial will receive either MK-2060 or a placebo to further evaluate its effectiveness. ^{1 4 5 6 7}

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 stage 4 or 5 chronic kidney disease, or those on peritoneal dialysis due to end-stage kidney disease. Participants must have a BMI between 18 and 45 kg/m^2. People with recent cancer (except certain skin cancers), blood clots, bleeding disorders, ongoing anticoagulant therapy (except aspirin), recent major surgery or blood donation, immunoglobulin treatments within the last year, biological therapies in the past three months (excluding erythropoietin and insulin), GI bleeding issues in the past five years, frequent nosebleeds or active gingivitis are excluded.

Inclusion Criteria

Your body mass index (BMI) is between 18 and 45.

I have severe chronic kidney disease or am on peritoneal dialysis.

Exclusion Criteria

I have had frequent nosebleeds or gum disease in the last 3 months.

I am on blood thinners, but aspirin is okay.

You have hepatitis B or HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1: Single Dose Administration

Participants receive a single subcutaneous dose of MK-2060 or placebo

1 day

1 visit (in-person)

Part 2: Multiple Dose Administration

Participants receive multiple subcutaneous doses of MK-2060 or placebo

22 days

7 visits (in-person)

Part 3: Single Dose Administration for End-Stage Kidney Disease

Participants with end-stage kidney disease receive a single subcutaneous dose of MK-2060

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 144 days

What Are the Treatments Tested in This Trial?

Interventions

• MK-2060

Trial Overview The study tests MK-2060's safety and effects when given as a single subcutaneous dose to people with advanced kidney disease. It has three parts: one for CKD stages 4 and 5 participants receiving one dose; another where they receive multiple doses; and a third part involving patients with end-stage kidney disease on dialysis.

How Is the Trial Designed?

Group I: MK-2060 30 mg Experimental Treatment 1 Intervention

Participants received MK-2060 30 mg administered as a single subcutaneous dose on Day 1.

Group II: Placebo Placebo Group 1 Intervention

Participants received placebo (normal saline) administered as a single subcutaneous dose on Day 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

Citations

1. clinicaltrials.eu clinicaltrials.eu/inn/mk-2060/

Mk-2060 – Application in Therapy and Current Clinical ... MK-2060 is an investigational drug being developed to prevent thrombotic complications in patients with end-stage renal disease (ESRD) undergoing hemodialysis.

2. renalandurologynews.com renalandurologynews.com/reports/factor-xi-arteriovenous-graft-thrombosis-rate-treatment-risk/

Inhibiting Factor XI Does Not Decrease Arteriovenous Graft ... The monoclonal antibody MK-2060 does not meaningfully lower arteriovenous graft (AVG) thrombosis among patients with end-stage kidney disease (ESKD) on ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05769595

NCT05769595 | Single Dose Study of MK-2060 to Evaluate ... The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous ...

4. conferences.medicom-publishers.com conferences.medicom-publishers.com/specialisation/nephrology/factor-xi-inhibition-not-useful-for-end-stage-kidney-disease-patients-receiving-haemodialysis/

Factor XI inhibition not useful for end-stage kidney disease ... 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 ...

5. merck.com merck.com/news/merck-receives-fast-track-designation-from-the-u-s-fda-for-mk-2060-an-investigational-anticoagulant-therapy/

Merck Receives Fast Track Designation from the U.S. FDA ... MK-2060 is a novel inhibitor of Factor XI being investigated for the prevention of thrombosis in patients with end-stage renal disease (ESRD).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05335005

Study Details | NCT05335005 | MK-2060 and Clopidogrel ... The purpose of this study is to conduct a preliminary evaluation of the safety and tolerability of MK-2060 treatment in combination with a commonly used P2Y12 ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-of-mk-2060-in-participants-with-chronic-kidney-disease-mk2060011

A Study of MK-2060 in Participants With Chronic and/or End ... The purpose of Part 1 of the study was to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose ...