MK-2060 Global Study in Patients with End Stage Renal Disease Receiving Hemodialysis
- Conditions
- Prevention of arteriovenous graft thrombosisMedDRA version: 20.1Level: PTClassification code: 10053182Term: Arteriovenous graft thrombosis Class: 100000004863Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-511055-17-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 545
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1.To evaluate the efficacy of MK-2060 compared to placebo in increasing the time to first arteriovenous graft thrombosis event.;Secondary Objective: To evaluate the efficacy of MK-2060 compared to placebo in increasing the time to each arteriovenous graft thrombosis event (first and recurrent)., To assess the safety and tolerability of MK-2060.;Primary end point(s): Time to First AVG Thrombosis Event
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Time to Each Arteriovenous Graft Thrombosis Event (First and Recurrent);Secondary end point(s):Number of Participants who Experience One or More Adverse Events (AEs);Secondary end point(s):Number of Major Bleeding Events or Clinically Relevant Non-Major Bleeding Events per International Society on Thrombosis (ISTH) Criteria;Secondary end point(s):Number of Participants Who Discontinue Study Intervention Due to an AE