NCT05769595CompletedPhase 1
Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)
A Single-dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-2060 in Japanese Older Participants With End-stage Renal Disease on Dialysis.
Source: ClinicalTrials.gov · Last updated 14 Mar 2025
Brief summary (registry, in English)
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of MK-2060 after a single dose intravenous (IV) administration in Japanese older participants with end stage renal disease (ESRD) on dialysis. There is no primary hypothesis for this study.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (actual)
- First submitted
- 3 Mar 2023
- Start date
- Jun 2023
- Primary completion date
- Feb 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Chronic kidney disease
- NCT number
- NCT05769595
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 17
- From Jun 2023 to the primary completion date, Feb 2024
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of vascular access thrombosis within 1 month prior to Screening 1
- 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
Other illness
- History of deep vein thrombosis or pulmonary embolism
- Personal or family history of bleeding disorder
Lab values
- 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
Other
- The main exclusion criteria include but are not limited to the following:
- On peritoneal dialysis or other dialysis modalities except for HD and HDF
Who the study is looking for
- 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
Age in the registry: 50 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Keiaikai Nakamura Hospital ( Site 1213) Coordinator of this site? Confirm its status | Beppu | Japan | Unknown status |
| Japanese Red Cross Fukuoka Hospital ( Site 1214) Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Shonan Kamakura General Hospital ( Site 1205) Coordinator of this site? Confirm its status | Kamakura | Japan | Unknown status |
| Ibaraki Prefectural Central Hospital ( Site 1211) Coordinator of this site? Confirm its status | Kasama | Japan | Unknown status |
| Kasugai Municipal Hospital ( Site 1203) Coordinator of this site? Confirm its status | Kasugai | Japan | Unknown status |
| Omi Fureai Hospital ( Site 1204) Coordinator of this site? Confirm its status | Kusatsu | Japan | Unknown status |
| Jomo Ohashi Clinic ( Site 1210) Coordinator of this site? Confirm its status | Maebashi | Japan | Unknown status |
| Matsumoto City Hospital ( Site 1209) Coordinator of this site? Confirm its status | Matsumoto | Japan | Unknown status |
| Kojunkai Daido Hospital ( Site 1207) Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Chubu Rosai Hospital ( Site 1202) Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Ikegami General Hospital ( Site 1206) Coordinator of this site? Confirm its status | Ōta-ku | Japan | Unknown status |
| Yamagata Tokushukai Hospital ( Site 1201) Coordinator of this site? Confirm its status | Yamagata | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.