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

COMPLETEDPHASE1

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

A Study to Evaluate Safety and Tolerability of Co-administration of MK-2060 and Clopidogrel in Participants With End-Stage Renal Disease on Hemodialysis

NCT05335005•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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, București, Romania

Key Dates

Start Date

May 30, 2022

Primary Completion Date

February 14, 2023

Completion Date

February 14, 2023

Last Updated

October 17, 2024

Enrollment

ACTUAL participants

Conditions

End-Stage Renal DiseaseKidney Failure, Chronic

Interventions

MK-2060

DRUG

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Kidney Disease, End-StageEnd-stage Renal Disease+1 more

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RECRUITINGPHASE3

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 17, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD

First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

Effects of Royal Jelly Supplementation in Chronic Kidney Disease