JPRN-jRCT2041230025进行中（未招募）1 期
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.
Tanaka Yoshiyuki0 个研究点目标入组 16 人开始时间: 2023年5月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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