jRCT2041230025已完成不适用
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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MSD K.K.
- 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
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 50age old over 至 80age old under（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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