Phase 1
Completed N=17
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
Source: ClinicalTrials.gov NCT05769595 ↗
Enrolled (actual)
17
Serious AEs
23.5%
Results posted
Mar 2025
Primary outcomePrimary: Number of Participants Who Experienced an Adverse Event (AE) — 10; 4 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced an Adverse Event (AE) |
10; 4 | — |
| PRIMARY Number of Participants Who Discontinued Study Due to an AE |
0; 0 | — |
| SECONDARY Area Under the Concentration-Time Curve of MK-2060 From Time 0 to Infinity (AUC 0-inf) |
35000 | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve of MK-2060 From Time 0 to Last (AUC0-last) |
34500 | — |
| SECONDARY Area Under the Concentration-Time Curve of MK-2060 From Time 0 to 168 Hours Postdose (AUC0-168) |
10100 | — |
| SECONDARY Maximum Concentration (Cmax) of MK-2060 |
110 | — |
| SECONDARY Concentration at 168 Hours (C168) Postdose of MK-2060 |
39.0 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of MK-2060 |
1.03 | — |
| SECONDARY Time of the Last Measurable Plasma Concentration (Tlast) of MK-2060 |
3407.34 | — |
| SECONDARY Terminal Half-Life (t ½) of MK-2060 |
22.7 | — |
| SECONDARY Clearance (CL) of MK-2060 |
0.00964 | — |
| SECONDARY Volume of Distribution (Vz) of MK-2060 |
7.58 | — |
| SECONDARY Change From Baseline in Activated Partial Thromboplastin Time (aPTT) |
2.45; 0.97 | — |
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
Data sourced from ClinicalTrials.gov (NCT05769595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.