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

NCT07234890 · tracked via the Priya Life Science Canada tracker

Sponsor

London Health Sciences Centre Research Institute

Phase

Phase 2

Started

2025-12-16

Last updated

2026-04-17

Condition(s) studied

Hemodialysis

Investigational drug(s) / intervention(s)

AV-001 or Placebo Injection

AV-001 or Placebo Injection: AV-001 or Placebo administered via IV bolus injection.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Ability to provide informed consent * Male and non-pregnant female patients (\>18 years old) * HD for ≥ 3 months * Thrice weekly HD schedule Exclusion Criteria: * HD \<90 days * Contraindication to MRI * Established severe cognitive impairment (Montreal Cognitive Assessment test (MoCA) \<18 or formal diagnosis of dementia) * Previous clinical stroke * Pregnancy, breastfeeding, or intending pregnancy * Intradialytic hypotension event (defined as: drop in SBP ≥40mmHg + symptoms + intervention) in previous month as evidenced by HD record

Primary outcome measure(s)

Evaluate the effect of AV-001 (high dose, low dose) on structural brain injury associated with HD, using MRI as compared to placebo controls. — Before and after dialysis on study visit day 3.
We will assess brain structure using MRI, allowing accurate detailed study of brain WM structural integrity.

Trial sites (1)

Facility	City	Region	Status
London Health Sciences Centre	London	Ontario	Recruiting

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Other trials for the same condition

Outcomes of a Higher vs. Lower Hemodialysate Magnesium Concentration (Dial-Mag) Active, not recruiting

Liberalizing Potassium Restrictions in Patients Receiving Hemodialysis Starting soon

Exercise Preconditioning to Protect Against Dialysis-induced Cardiac Injury Recruiting

Assessment of a Wearable Ultrafiltration Device Starting soon

Dialysis Less Frequently in the Elderly Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07234890 on ClinicalTrials.gov ↗ ← All trials in Canada