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 - MK-2060-007

Merck Sharp & Dohme LLC0 个研究点目标入组 545 人开始时间: 2024年5月28日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•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.

•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.

发起方