2024-511055-17-00已完成2 期
A Randomized Parallel-group, Placebo-controlled, Double-blind, Eventdriven, Multi-center Phase 2 Clinical Outcome Trial of Prevention of Arteriovenous Graft Thrombosis and Safety of MK-2060 in Patients With End Stage Renal Disease Receiving Hemodialysis
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 17
- 主要终点
- Time to First AVG Thrombosis Event
研究概览
简要总结
1.To evaluate the efficacy of MK-2060 compared to placebo in increasing the time to first arteriovenous graft thrombosis event.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of ESRD.
- •Receiving hemodialysis (including hemodiafiltration) ≥3 times per week for a minimum of 3 hours per session via a mature normally functioning, uninfected AVG with at least 75% of the sessions meeting these criteria over the 4 weeks prior to randomization
- •A female participant is not pregnant or breastfeeding, not a woman of child-bearing potential (WOCBP) or is a WOCBP and agrees to follow contraceptive guidance during the intervention period and for at least 90 days after the last dose of study intervention.
排除标准
- •Recent history of cancer (<1 year). Non-melanoma skin cancers are allowed.
- •Mechanical/prosthetic heart valve.
- •Recent hemorrhagic stroke or lacunar stroke (<1 month).
- •Recent evidence (<1 month) of bleeding requiring hospitalization or unplanned medical attention, a history (≤2 years) of recurrent bleeding episodes including epistaxis, gastrointestinal (GI) bleeds or genitourinary (GU) bleeds requiring medical treatment or events requiring treatment with blood products.
- •Recent history (<1 year) of drug or alcohol abuse or dependence.
- •Currently receiving or planning to receive anticoagulants or antiplatelet medications (intradialytic heparin and aspirin are permitted).
- •Planning on receiving a living donor renal transplant within 12 months (participants are permitted to be candidates for deceased donor renal transplants).
- •Planning on receiving an arteriovenous fistula (AVF) placement within 12 months.
结局指标
主要结局
Time to First AVG Thrombosis Event
Time to First AVG Thrombosis Event
次要结局
- Time to Each Arteriovenous Graft Thrombosis Event (First and Recurrent)
- Number of Participants who Experience One or More Adverse Events (AEs)
- Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria
- Number of Participants Who Discontinue Study Intervention Due to an AE
研究者
Brandon Atkins
Scientific
Merck Sharp & Dohme LLC
研究点 (17)
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