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NCT Number: NCT07234890

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

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.

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Key information

Conditions

Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location status: Recruiting

About this study

Hemodialysis provides life-sustaining treatment for many chronic kidney disease patients around the world. Moderate to severe cognitive impairment is very common in HD patients with up to 70% being affected who are ≥ 55 years of age and ~ 10% in those between 21-39 years of age. Significant cognitive impairment is evident within 6 months of starting HD.

This study is a phase 2 exploratory study in patients receiving hemodialysis treatments. Investigators will recruit 60 patients from the renal program at the London Health Sciences Centre.

Study participants will receive AV-001 (low or high dose) or placebo 60 minutes prior to HD initiation at 3 HD treatment sessions within 1 week (Monday, Wednesday and Friday)

Study participants will also undergo:

  • Vital sign collection (blood pressure and heart rate)
  • Blood collection
  • Cognitive assessments
  • Vascular ultrasound
  • MRI

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AV-001 or Placebo Injection

Drug

AV-001 or Placebo administered via IV bolus injection.

Primary outcomes

  1. Evaluate the effect of AV-001 (high dose, low dose) on structural brain injury associated with HD, using MRI as compared to placebo controls.

    Time frame: 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.

Secondary outcomes

  1. Evaluate circulating biomarkers of vascular injury (S-100β )

    Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)

    Blood Samples (S-100β) will be collected Pre-HD, Peak-HD and Post HD for analysis.

  2. Evaluate circulatory biomarkers of vascular injury (transthyretin)

    Time frame: Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)

    Blood samples (transthyretin) will be collected Pre-HD, Peak HD and Post HD for analysis.

  3. Evaluate circulatory biomarkers of vascular injury (TNF-a)

    Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)

    Blood Samples (TNF-a) will be collected Pre-HD, Peak-HD and Post HD for analysis

  4. Evaluate circulatory biomarkers of vascular injury (IL-6)

    Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)

    Blood samples (IL-6) will be collected Pre-HD, Peak-HD and Post HD for analysis

  5. Evaluate circulatory biomarkers of vascular injury (serum lipopolysaccharide)

    Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)

    Blood Samples (serum lipopolysaccharide) will be collected Pre-HD, Peak-HD and Post HD for analysis

  6. Evaluate circulatory biomarkers of vascular injury (complete blood count)

    Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)

    Blood Samples (complete blood count) will be collected Pre-HD, Peak-HD and Post HD for analysis.

  7. Evaluate circulatory biomarkers of vascular injury (urea)

    Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)

    Blood Samples (urea) will be collected Pre-HD, Peak-HD and Post HD for analysis.

  8. Evaluate circulatory biomarkers of vascular injury (electrolytes)

    Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)

    Blood Samples (electrolytes) will be collected Pre-HD, Peak-HD and Post HD for analysis.

  9. Evaluate circulating biomarkers of vascular injury (dialysate composition)

    Time frame: Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)

    Dialysate composition (sodium, potassium, calcium, magnesium, glucose) will be collected Pre-HD, Peak-HD and Post HD for analysis.

  10. Evaluate circulatory biomarkers of vascular injury (Clot)

    Time frame: Study visit Day 1 to Study Visit Day 3 (over a 1-week period)

    Blood Samples (clot-troponin T and C-reactive protein) will be collected Pre-HD, Peak-HD and Post HD for analysis.

  11. Evaluate circulatory biomarkers of vascular injury (AV-001 specific biomarkers)

    Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)

    AV-001 specific circulatory biomarkers (soluble Tie2, CXCL10, MCP-1, Angiopoietin-1, Angiopoietin-2) will be collected Pre-HD, Peak-HD and Post HD for analysis.

  12. Evaluate variations in cognitive assessment performance scores using Montreal Cognitive Assessment (MoCA)

    Time frame: Study Visit Day 1 to Study Visit Day 3 (1 week)

    The Montreal Cognitive Assessment (MoCA) is validated and highly sensitive for the detection of mild cognitive impairment and measures short term memory; visuospatial abilities; executive function; attention; concentration and working memory; language; and orientation to time and place.

  13. Evaluate variations in cognitive assessment performance scores using Trailsmaking Test A

    Time frame: Study Visit Day 1 to Study Visit Day 3 (1 week)

    The Trailsmaking 'A' Test is sensitive to various neurological impairments and provide information on visual search, scanning, speed of processing, mental flexibility and executive functions.

    The patient is asked to connect numbers 1 through 25 as quickly as possible.

  14. Trailsmaking B (TMTB)

    Time frame: Study Visit Day 1 to Study Visit Day 3 (1 week)

    The Trailsmaking 'B' Test is sensitive to various neurological impairments and provide information on visual search, scanning, speed of processing, mental flexibility and executive functions. Patients are asked to alternate numbers and letters which requires thinking flexibility and mental shifting.

  15. Evaluate variations in cognitive performance scores using Creyos

    Time frame: Study Visit Day 1 to Study Visit Day 3 (1 week)

    Creyos encompass assessments of short-term memory, reasoning, attention and verbal ability. Creyos is an online platform and will be completed on a study designated tablet.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute

Other

Collaborators

  • Vasomune Therapeutics, Inc.

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Exploratory Study to Evaluate the Neuroprotective Effects of AV-001 on Hemodialysis-induced Brain Injury Via Cerebrovascular Stabilization in Chronic Hemodialysis Patients

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 19, 2025
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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