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

Merck Sharp & Dohme LLC12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

End-Stage Renal Disease Kidney Failure, Chronic

Interventions

MK-2060DRUG

MK-2060 administered via IV infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (3)

Genesis Clinical Research, LLC ( Site 0003)

Tampa, Florida, United States

Hadassah Medical Center-Clinical Reaserch Unit ( Site 0002)

Jerusalem, Israel

ARENSIA Exploratory Medicine-Clinical Nephrology Hospital "Carol Davila" ( Site 0001)

Bucharest, Bucharest, Romania

Outcomes

Primary Outcomes

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

Bleeding related AEs include any sign or symptom of bleeding, even if not requiring intervention by a medical/healthcare professional, as well as clinically-relevant non major bleeding or major bleeding.

Time frame: Up to approximately 104 days

Number of Participants Who Experience One or More AEs

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Time frame: Up to approximately 104 days

Number of Participants Who Discontinue Study Intervention Due to an AE

Time frame: Up to approximately 8 days

Secondary Outcomes

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

The AUC0-168 was defined as the area under the concentration-time curve of MK-2060 in plasma from time zero to 168 hours after administration. The Week 1 value is the extrapolated value using data up to 48 hours postdose Day 1, with the "Partial area" option in WinNonlin software using a Start time of 0 hours and an End time of 168 hours. Week 2 value included data for Day 8: predose, and 1, 12, 24, 48, 96, and 168 hours postdose.

Time frame: Day 1: predose, and 1, 12, 24, and 48 hours postdose. Day 8: predose, and 1, 12, 24, 48, 96, and 168 hours postdose.

Data from ClinicalTrials.gov

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