Status:
COMPLETED
MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
End-Stage Renal Disease
Kidney Failure, Chronic
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2023
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05335005
Start Date
May 30 2022
End Date
February 14 2023
Last Update
October 17 2024
Active Locations (3)
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1
Genesis Clinical Research, LLC ( Site 0003)
Tampa, Florida, United States, 33603
2
Hadassah Medical Center-Clinical Reaserch Unit ( Site 0002)
Jerusalem, Israel, 9112001
3
ARENSIA Exploratory Medicine-Clinical Nephrology Hospital "Carol Davila" ( Site 0001)
Bucharest, București, Romania, 010701