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

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

End-Stage Renal Disease (ESRD)

End-Stage Kidney Disease (ESKD)

Kidney Failure, Chronic

Treatments

Drug: Placebo

Biological: MK-2060

Study type

Interventional

Funder types

Industry

Identifiers

NCT05769595

jRCT2041230025 (Registry Identifier)

MK-2060-012 (Other Identifier)

2060-012

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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