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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

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

Treatments: Drug: MK-2060

Study type: Interventional

Funder types: Industry

Identifiers

NCT05335005

2021-005333-17 (EudraCT Number)

MK-2060-008 (Other Identifier)

2060-008

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

MK-2060

Experimental group

Description:

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:

Drug: MK-2060