MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-30

Study Completion Date

2023-02-14

Brief Summary

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MK-2060 is being developed for prevention of thrombotic complications in end-stage renal disease (ESRD). 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 receptor inhibitor, clopidogrel, in ESRD patients.

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Detailed Description

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Conditions

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End-Stage Renal Disease Kidney Failure, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MK-2060

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.

Group Type EXPERIMENTAL

MK-2060

Intervention Type DRUG

MK-2060 administered via IV infusion

Interventions

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MK-2060

MK-2060 administered via IV infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Has End-Stage Renal Disease (ESRD) maintained on stable outpatient hemodialysis (HD) regimen at a healthcare center for \> 3 months prior to dosing.
* On HD regimen at least 3 times per week for a minimum of 3 hours per dialysis session, using a complication-free well-maintained AV fistula or AV graft.
* Is taking clopidogrel for a minimum of 2 weeks prior to the first dosing of MK-2060 administration.
* Has a Body Mass Index (BMI) ≥ 18 and ≤ 45 kg/m\^2.

Exclusion Criteria

* History of cancer (malignancy), including adenocarcinoma, except adequately treated nonmelanomatous skin carcinoma or carcinoma in situ of the cervix or other malignancies that have been successfully treated with appropriate follow up.
* Has a history of deep vein thrombosis or pulmonary embolism.
* Has a history of gastrointestinal (GI) bleeding, duodenal polyps or gastric ulcer in the last 5 years or severe hemorrhoidal bleed in last 3 months prior to screening.
* Is positive for hepatitis B surface antigen or human immunodeficiency virus (HIV).
* Has ongoing anticoagulant therapy or antiplatelet therapy, not including clopidogrel. Intradialytic heparin is permitted.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No