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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 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.

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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.

Conditions Studied

End Stage Renal Disease Kidney Failure, Chronic End-Stage Kidney Disease

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

FieldValue
Enrollment Target 506 participants
Start Date 2021-09-17
Est. Completion 2025-02-13
Phase Phase 2

Sponsor

Merck Sharp & Dohme

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05027074

The ClinicalTrials.gov registry entry for NCT05027074 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 506 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 828-participant average among 86 other End Stage Renal Disease trials with a reported enrollment target (39% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 3 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.