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Antiplatelet Agent

MK-2060 for Kidney Failure

Phase 1

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1: predose, and 1, 12, and 48 hours postdose. day 8: predose, and 1, 12, and 24 hours postdose; and once daily on days 10, 12, 15, 21, 29, 35, 49, 67, and 104.

Awards & highlights

No Placebo-Only Group

Summary

This trial tests MK-2060, a new drug to prevent blood clots, in patients with severe kidney disease. It is used with clopidogrel, a common anti-clotting medication. The goal is to see if this combination is safe and well-tolerated.

Eligible Conditions

Kidney Failure
Chronic Kidney Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1: predose, and 1, 12, and 48 hours postdose. day 8: predose, and 1, 12, and 24 hours postdose; and once daily on days 10, 12, 15, 21, 29, 35, 49, 67, and 104.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1: predose, and 1, 12, and 48 hours postdose. day 8: predose, and 1, 12, and 24 hours postdose; and once daily on days 10, 12, 15, 21, 29, 35, 49, 67, and 104.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1: predose, and 1, 12, and 48 hours postdose. day 8: predose, and 1, 12, and 24 hours postdose; and once daily on days 10, 12, 15, 21, 29, 35, 49, 67, and 104. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Participants Who Discontinue Study Intervention Due to an AE

Number of Participants Who Experience One or More AEs

Number of Participants Who Experience One or More Bleeding Related Adverse Events (AE)

Secondary study objectives

Apparent Volume of Distribution at Steady State (Vss) of MK-2060

Area Under the Concentration-Time Curve From 0 to 168 Hours (AUC0-168) of MK-2060

Clearance at Steady State (CLss) of MK-2060

+5 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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: MK-2060Experimental Treatment1 Intervention

Participants continued their established background therapy of daily 75 mg clopidogrel for 2 weeks (days -14 to 0). Participants then continued background therapy while receiving 25 mg MK-2060 intravenous (IV) infusion on days 1, 3, 5, and 8.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MK-2060

2019

Completed Phase 1

~90

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