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

Completed · Phase 1

Conditions studied: End-Stage Renal Disease, Kidney Failure, Chronic

In brief

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.

Key facts

Study ID

NCT05335005

Run by

Merck Sharp & Dohme LLC

People needed

12

Starts

2022-05-30

Expected to finish

2023-02-14

Last updated by the study team

2024-10-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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