CTIS2024-511055-17-00
Recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prevention of arteriovenous graft thrombosis
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 545
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A global trial to evaluate the efficacy and safety of MK-2060 in patients with end stage renal disease receiving hemodialysisPrevention 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 complicationsTherapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]EUCTR2020-002397-27-CZMerck Sharp & Dohme LLC489
Active, not recruiting
Phase 1
A global trial to evaluate the efficacy and safety of MK-2060 in patients with end stage renal disease receiving hemodialysisEUCTR2020-002397-27-BGMerck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.489
Active, not recruiting
Phase 1
A global trial to evaluate the efficacy and safety of MK-2060 in patients with end stage renal disease receiving hemodialysisPrevention 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 complicationsTherapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]EUCTR2020-002397-27-PTMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.489
Completed
Phase 2
MK-2060 Global Study in Patients with End Stage Renal Disease Receiving Hemodialysis2024-511055-17-00Merck Sharp & Dohme LLC, Merck Sharp & Dohme LLC93
Active, not recruiting
Phase 1
VerICiguaT Global Study in Subjects With Heart Failure With Reduced Ejection Fraction (VICTORIA)Treatment of chronic heart failure with reduced ejection fraction (HFrEF)MedDRA version: 19.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]EUCTR2016-000671-25-NLMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.4,872