A Randomized Parallel-group, Placebo-controlled, Double-blind, Event-driven, 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 Global Study in Patients with End Stage Renal Disease Receiving Hemodialysis

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites489 target enrollmentFebruary 16, 2022

ConditionsPrevention of arteriovenous graft thrombosis in patients with end stage renal disease receiving hemodialysis.MedDRA version: 20.1Level: PTClassification code 10053182Term: Arteriovenous graft thrombosisSystem Organ Class: 10022117 - Injury, poisoning and procedural complications Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Prevention of arteriovenous graft thrombosis in patients with end stage renal disease receiving hemodialysis.
Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Enrollment: 489
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 16, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Eligibility Criteria

Inclusion Criteria

•1\. Has a current diagnosis of ESRD.
•2\. Has been receiving hemodialysis \=3 times per week with each hemodialysis session being a minimum of 3 hours duration via a normally functioning (spKt/V \=1\.2\), uninfected AVG for at least 4 weeks.
•3\. Is male or female, \=18 years of age inclusive, at the time of signing the informed consent.
•4\. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
•Is not a WOCBP
•Is a WOCBP and using an acceptable contraceptive method, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 90 days, corresponding to the time needed to eliminate any study intervention (eg, 5 terminal half\-lives) after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
•A WOCBP must have a negative highly sensitive pregnancy test (serum) within 72 hours before the first dose of study intervention.
•The participant must be excluded from participation if the serum pregnancy result is positive.
•The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
•Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

•1\. Has a recent history of cancer (\<1 year). Non\-melanoma skin cancers are allowed.
•2\. Has a mechanical/prosthetic heart valve.
•3\. Had a recent hemorrhagic stroke or lacunar stroke (\<1 month).
•4\. Had recent evidence of bleeding requiring hospitalization or unplanned medical attention (\<1 month), a history (\=2 years) of recurrent bleeding episodes including epistaxis, GI bleeds or GU bleeds requiring medical treatment or events requiring treatment with blood products.
•5\. Has a recent history of drug or alcohol abuse or dependence (\<1 year).
•6\. Life expectancy \<12 months.
•7\. Is currently receiving or planning to receive anticoagulants or antiplatelet medications (Individuals that plan to be on low dose aspirin (up to 150 mg per day) during the study or require intradialytic heparin, are permitted in the study).
•Prohibited Medications:
•\- Oral Anticoagulants: Warfarin, Apixaban, Dabigatran, Rivaroxaban, Edoxaban, Betrixaban.
•\- IV/SC Anticoagulants: IV/SC Heparin and LMWH, IV Warfarin, IV Argatroban, IV Bivalirudin, IV Lepirudin, SC fondaparinux, IV antithrombin III.