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NCT05027074 · ClinicalTrials.gov registry record · Phase 2
Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)
A Phase 2 study of End Stage Renal Disease and Kidney Failure, Chronic, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 2
- Development phase
- 506
- Enrollment target
- 20
- Study locations
NCT05027074: Completed Phase 2 study of End Stage Renal Disease and Kidney Failure, Chronic, sponsored by Merck Sharp & Dohme.
NCT05027074 is a Phase 2 study of End Stage Renal Disease and Kidney Failure, Chronic that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 506 participants, below the 828-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (39% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05027074, a Phase 2 study of End Stage Renal Disease and Kidney Failure, Chronic, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 506 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an arteriovenous graft (AVG). Data from this study will be used to aid dose selection of MK-2060 in future studies. The primary hypothesis is that at least one of the MK-2060 doses is superior to placebo in increasing the time to first occurrence of AVG event.
Primary Outcome
An AVG thrombosis event is defined as the sudden occlusion of the participant's AVG requiring thrombectomy/thrombolysis, or clinical evidence of thrombosis with surgical, radiological or pathological conformation of an AVG thrombosis. A blinded independent clinical adjudication committee (CAC) adjudicated AVG thrombosis events. A time-to-event methodology was used to evaluate the results. The incidence rate is presented.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG MK-2060
Study Locations (20)
California
- DaVita Anaheim West Dialysis-Davita Anaheim West Dialysis - Ismail ( Site 0562) - Anaheim
- DaVita Bakersfield Oak Street Dialysis-Clinical Research ( Site 0547) - Bakersfield
- Fresenius Kidney Care Bakersfield Northeast ( Site 0647) - Bakersfield
- Fresenius Kidney Care Meadows Field ( Site 0618) - Bakersfield
- California Institute Of Renal Research ( Site 0660) - Chula Vista
- Citrus Dialysis Center ( Site 0609) - Covina
- California Institute Of Renal Research ( Site 0679) - El Centro
- California Institute of Renal Research ( Site 0566) - Escondido
- Fresenius Kidney Care Newhope Fountain Valley ( Site 0617) - Fountain Valley
- DaVita Glendale Heights ( Site 0604) - Glendale
- DaVita West Glendale Dialysis ( Site 0579) - Glendale
- DaVita North Glendale ( Site 0552) - Glendale
- California Institute of Renal Research - La Mesa ( Site 0682) - La Mesa
- La Puente Dialysis Center ( Site 0610) - La Puente
- Academic Medical Research Institute ( Site 0533) - Los Angeles
- DaVita Kidney Center - East LA Plaza Dialysis ( Site 0548) - Los Angeles
- DaVita Crescent Heights Dialysis Center ( Site 0574) - Los Angeles
Arizona
- AKDHC MEDICAL RESEARCH SERVICES, LLC-Maryvale ( Site 0723) - Phoenix
- AKDHC Medical Research Services, LLC ( Site 0629) - Tucson
Alabama
- Nephrology Consultants ( Site 0681) - Huntsville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 506 participants |
| Start Date | 2021-09-17 |
| Est. Completion | 2025-02-13 |
| Phase | Phase 2 |
What the finished NCT05027074 record still lists
NCT05027074 is an interventional study that assigns participants to a tested intervention. The registered 506 participants enrollment target is mid-sized for trials with a published cap, below the 828-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (39% lower).
The record links to 3 conditions, with End Stage Renal Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05027074 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT05027074 about?
NCT05027074 is a clinical study titled "Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)". The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an arteriovenous graft (AVG). Data from this study will be used to aid dose selection...
What is the current status of trial NCT05027074?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 506 participants. The study started on 2021-09-17. Estimated completion is 2025-02-13.
What conditions does trial NCT05027074 study?
This clinical trial studies the following conditions: End Stage Renal Disease, Kidney Failure, Chronic, End-Stage Kidney Disease.
What interventions are being tested in trial NCT05027074?
The interventions under investigation include: Placebo (DRUG), MK-2060 (DRUG).
Who is sponsoring clinical trial NCT05027074?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05027074 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05027074's enrollment target sits among peer trials
506 12th of 86 higher than 75 of 86 other End Stage Renal Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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