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NCT05769595 | COMPLETED | End-Stage Renal Disease (ESRD)

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

Merck Sharp & Dohme LLC

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.

Condition or disease

End-Stage Renal Disease (ESRD)

End-Stage Kidney Disease (ESKD)

Kidney Failure, Chronic

Intervention/treatment

MK-2060

Placebo

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 17 participants
Masking : DOUBLE
Masking Description : Double blind
Primary Purpose : TREATMENT
Official Title : 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.
Actual Study Start Date : 2023-06-14
Estimated Primary Completion Date : 2024-02-15
Estimated Study Completion Date : 2024-02-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Single Dose Study of MK-2060 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Older Japanese Participants on Dialysis (MK-2060-012)

Location Details

NCT05769595

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Japan, Aichi

Kasunga Municipal Hospital (Site 1203)

Kasugai, Aichi, Japan, 486-8510

Not yet recruiting

Japan, Aichi

Chubu Rosai Hospital (Site 1202)

Nagoya, Aichi, Japan, 455-8530

Not yet recruiting

Japan, Aichi

Small Cruise Dyed Supplement Spita L (1207)

Nagoya, Aichi, Japan, 457-8511

Not yet recruiting

Japan, Gunma

Jum Ohshi Clinic (Site 120)

Maebashi, Gunma, Japan, 371-0046

Not yet recruiting

Japan, Ibaraki

Ibaraki Prefectural Central Hospital (Website 1211)

Included, Ibaraki, Japan, 309-1793

Not yet recruiting

Japan, Kanagawa

Shonan Kamakura General Hospital ( Site 1205)

Kamakura, Kanagawa, Japan, 247-8533

Not yet recruiting

Japan, Nagano

Matsumoto City Hospital ( Site 1209)

Matsumoto, Nagano, Japan, 390-1401

Not yet recruiting

Japan, Do

Keiaikai Nakamura Hospital ( Site 1213)

Beppu, And do, Japan, 874-0937

Not yet recruiting

Japan, Enter

Seeing and touching (1204)

Kusatsu, Enter, Japan, 525-8585

Not yet recruiting

Japan, Tokyo

Ikegami General Hospital ( Site 1206)

Ota, Tokyo, Japan, 146-8531

Not yet recruiting

Japan,

Japanese Red Cross Fukuoka Hospital ( Site 1214)

Fukuoka, Japan, 815-8555

Not yet recruiting

Japan,

Yamagata Special Solution Supplement Spita L (1201)

Yamagata, Japan, 990-0834