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Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.

NCT07234890 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-17

No results posted yet for this study

Summary

Cognitive decline is increasingly recognized among patients receiving maintenance hemodialysis (HD). This can include trouble remembering, slower thinking or mentally feeling foggy.

This research is being done to determine if a new medication (AV-001) can protect the brain from injury caused by hemodialysis by strengthening blood vessels in the brain and reducing inflammation.

If successful, this research could lead to better protection for the brains of people undergoing regular dialysis, potentially reducing the risk of cognitive decline and stroke.

Conditions

  • Hemodialysis

Interventions

DRUG

AV-001 or Placebo Injection

AV-001 or Placebo administered via IV bolus injection.

Sponsors & Collaborators

  • Vasomune Therapeutics, Inc.

    collaborator INDUSTRY

  • London Health Sciences Centre Research Institute

    lead OTHER

Principal Investigators

  • Christopher W McIntyre, MD/PhD · London Health Science Centre

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-16
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234890 on ClinicalTrials.gov