Single Dose Study of MK-2060 in Japanese Older Participants on Dialysis

Phase 1

• Conditions: end-stage renal disease

• Registration Number: JPRN-jRCT2041230025
• Lead Sponsor: Tanaka Yoshiyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1) Japanese descent with all 2 biological parents of Japanese descent
2) 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
3) Be judged to plan to continue or anticipate the use of the current AV fistula or AV graft until the poststudy visit

Exclusion Criteria

1) On peritoneal dialysis or other dialysis modalities except for HD and HDF
2) History of deep vein thrombosis or pulmonary embolism
3) History of vascular access thrombosis within 1 month prior to Screening 1
4) Personal or family history of bleeding disorder
5) 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
6) History of frequent epistaxis within 3 months prior to Screening 1 or active gingivitis
7) At the time of screening or predose, planned significant dental procedures, or other planned surgical procedures within duration of participation in the trial
8) 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
9) 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
10) Requires or anticipates requiring the use of following prohibited medications until the poststudy visit: anticoagulants, antiplatelet medications and non-steroidal anti-inflammatory drugs (NSAIDs)
11) Participated in another investigational study within 1 month prior to Screening 1
12) 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified