Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)

NCT ID: NCT05769595

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-14
• Study Completion Date: 2024-02-15

Brief 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.

Conditions

End-Stage Renal Disease (ESRD); End-Stage Kidney Disease (ESKD); Kidney Failure, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-2060

Participants receive MK-2060 50 mg via a single intravenous (IV) infusion over 60-minutes.

Group Type: EXPERIMENTAL

MK-2060

Intervention Type: BIOLOGICAL

Lyophilized powder diluted in normal saline for IV infusion

Placebo

Participants receive a single IV saline infusion over 60 minutes.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

IV infusion

Interventions

MK-2060

Lyophilized powder diluted in normal saline for IV infusion

Intervention Type: BIOLOGICAL

Placebo

IV infusion

Intervention Type: DRUG

Other Intervention Names

Normal saline

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Kasugai Municipal Hospital ( Site 1203)

Kasugai, Aichi-ken, Japan

Chubu Rosai Hospital ( Site 1202)

Nagoya, Aichi-ken, Japan

Kojunkai Daido Hospital ( Site 1207)

Nagoya, Aichi-ken, Japan

Jomo Ohashi Clinic ( Site 1210)

Maebashi, Gunma, Japan

Ibaraki Prefectural Central Hospital ( Site 1211)

Kasama, Ibaraki, Japan

Shonan Kamakura General Hospital ( Site 1205)

Kamakura, Kanagawa, Japan

Matsumoto City Hospital ( Site 1209)

Matsumoto, Nagano, Japan

Keiaikai Nakamura Hospital ( Site 1213)

Beppu, Oita Prefecture, Japan

Omi Fureai Hospital ( Site 1204)

Kusatsu, Shiga, Japan

Ikegami General Hospital ( Site 1206)

Ōta-ku, Tokyo, Japan

Japanese Red Cross Fukuoka Hospital ( Site 1214)

Fukuoka, , Japan

Yamagata Tokushukai Hospital ( Site 1201)

Yamagata, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-2060-012

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2041230025

Identifier Type: REGISTRY

Identifier Source: secondary_id

2060-012

Identifier Type: -

Identifier Source: org_study_id