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COMPLETED 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)

NCT05027074 · View on ClinicalTrials.gov ↗

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.

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

741 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 506 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Kidney Failure, Chronic appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05027074 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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: Kidney Failure, Chronic, End-Stage Renal Disease, End-Stage Kidney Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05027074?

The interventions under investigation include: Placebo (DRUG), MK-2060 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05027074?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial