Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)
End-Stage Renal Disease (ESRD), End-Stage Kidney Disease (ESKD), Kidney Failure, Chronic
About this trial
This is an interventional treatment trial for End-Stage Renal Disease (ESRD)
Eligibility Criteria
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: Japanese descent with all 2 biological parents of Japanese descent On hemodialysis (HD) or hemodiafiltration (HDF) with single-pool Kt/V (spKt/V) ≥1.2, using arteriovenous (AV) fistula or AV graft ≥3 months prior to Screening 1 at a healthcare center, and is on the same dialysis regimen ≥2 weeks prior to Screening 1 Be judged to plan to continue or anticipate the use of the current AV fistula or AV graft until the poststudy visit Exclusion Criteria: The main exclusion criteria include but are not limited to the following: On peritoneal dialysis or other dialysis modalities except for HD and HDF History of deep vein thrombosis or pulmonary embolism History of vascular access thrombosis within 1 month prior to Screening 1 Personal or family history of bleeding disorder History of GI bleeding, duodenal polyps or active gastroduodenal ulcer within 5 years prior to Screening 1, or history of severe hemorrhoidal bleed within 3 months prior to Screening 1 History of frequent epistaxis within 3 months prior to Screening 1 or active gingivitis At the time of screening or predose, planned significant dental procedures, or other planned surgical procedures within duration of participation in the trial History of receiving any human immunoglobulin preparation such as intravenous immunoglobulin (IVIG) or a brand of Rho(D) immune globulin (RhoGAM) within 1 year prior to Screening 1 History of receiving any biological therapy within 3 months prior to Screening 1, or vaccination within 1 month prior to the dose of study intervention Requires or anticipates requiring the use of following prohibited medications until the poststudy visit: anticoagulants, antiplatelet medications and non-steroidal anti-inflammatory drugs (NSAIDs) Participated in another investigational study within 1 month prior to Screening 1 Has blood coagulation test (activated partial thromboplastin time [aPTT] or prothrombin time [PT]) above 1.2X upper limit of normal (ULN) at Screening 1 from the central laboratory for safety
Sites / Locations
- Kasugai Municipal Hospital ( Site 1203)
- Chubu Rosai Hospital ( Site 1202)
- Kojunkai Daido Hospital ( Site 1207)
- Jomo Ohashi Clinic ( Site 1210)
- Ibaraki Prefectural Central Hospital ( Site 1211)
- Shonan Kamakura General Hospital ( Site 1205)
- Matsumoto City Hospital ( Site 1209)
- Keiaikai Nakamura Hospital ( Site 1213)
- Omi Fureai Hospital ( Site 1204)
- Ikegami General Hospital ( Site 1206)
- Japanese Red Cross Fukuoka Hospital ( Site 1214)
- Yamagata Tokushukai Hospital ( Site 1201)
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
MK-2060
Placebo
Participants receive MK-2060 50 mg via a single intravenous (IV) infusion over 60-minutes.
Participants receive a single IV saline infusion over 60 minutes.