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Antiplatelet Agent
MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)
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.
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 moreSide effects data
From 2021 Phase 1 trial • 38 Patients • NCT038730386%
Myocardial infarction
6%
Nausea
6%
Sneezing
100%
80%
60%
40%
20%
0%
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
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
4,027 Previous Clinical Trials
5,188,791 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharpe & Dohme LLC
2,900 Previous Clinical Trials
8,090,422 Total Patients Enrolled