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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hemodialysis
• Intervention / Treatment: Drug: AV-001 or Placebo Injection

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Kathy Koyle; Phone Number: 56214 519-685-8500; Email: kathleen.koyle@lhsc.on.ca
• Study Contact Backup: Name: Jarrin D Penny, PhD, RN; Phone Number: 58765 519-685-8500; Email: jarrin.penny@lhsc.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Recruiting
      • London Health Sciences Centre
      • Contact: Kathy Koyle; Phone Number: x 56214 519-685-8500; Email: kathleen.koyle@lhsc.on.ca
      • Contact: Jarrin Penny, PhD, RN; Phone Number: x 58765 519-685-8500; Email: jarrin.penny@lhsc.on.ca
      • Principal Investigator: Christopher McIntyre, MBBS DM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 Placebo; Participants randomized into one group 1placebo. Placebo will be administered 60 minutes prior to hemodialysis initiation, 3 x over a one-week treatment period.	Drug: AV-001 or Placebo Injection; AV-001 or Placebo administered via IV bolus injection.
Experimental: Group 2: AV-001 low dose (12.5μg/kg); Participants randomized into group 2 will receive AV-001 low dose. AV-001 low dose will be administered 60 minutes prior to hemodialysis initiation, 3 x over a one-week treatment period.	Drug: AV-001 or Placebo Injection; AV-001 or Placebo administered via IV bolus injection.
Experimental: Group 3: AV-001 High Dose (25μg/kg); Participants randomized into group 3 will receive AV-001 high dose. AV-001 high dose will be administered 60 minutes prior to hemodialysis initiation, 3 x over a one-week treatment period.	Drug: AV-001 or Placebo Injection; AV-001 or Placebo administered via IV bolus injection.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate circulating biomarkers of vascular injury (S-100β )	Blood Samples (S-100β) will be collected Pre-HD, Peak-HD and Post HD for analysis.	Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Evaluate circulatory biomarkers of vascular injury (transthyretin)	Blood samples (transthyretin) will be collected Pre-HD, Peak HD and Post HD for analysis.	Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)
Evaluate circulatory biomarkers of vascular injury (TNF-a)	Blood Samples (TNF-a) will be collected Pre-HD, Peak-HD and Post HD for analysis	Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Evaluate circulatory biomarkers of vascular injury (IL-6)	Blood samples (IL-6) will be collected Pre-HD, Peak-HD and Post HD for analysis	Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Evaluate circulatory biomarkers of vascular injury (serum lipopolysaccharide)	Blood Samples (serum lipopolysaccharide) will be collected Pre-HD, Peak-HD and Post HD for analysis	Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Evaluate circulatory biomarkers of vascular injury (complete blood count)	Blood Samples (complete blood count) will be collected Pre-HD, Peak-HD and Post HD for analysis.	Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Evaluate circulatory biomarkers of vascular injury (urea)	Blood Samples (urea) will be collected Pre-HD, Peak-HD and Post HD for analysis.	Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Evaluate circulatory biomarkers of vascular injury (electrolytes)	Blood Samples (electrolytes) will be collected Pre-HD, Peak-HD and Post HD for analysis.	Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Evaluate circulating biomarkers of vascular injury (dialysate composition)	Dialysate composition (sodium, potassium, calcium, magnesium, glucose) will be collected Pre-HD, Peak-HD and Post HD for analysis.	Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)
Evaluate circulatory biomarkers of vascular injury (Clot)	Blood Samples (clot-troponin T and C-reactive protein) will be collected Pre-HD, Peak-HD and Post HD for analysis.	Study visit Day 1 to Study Visit Day 3 (over a 1-week period)
Evaluate circulatory biomarkers of vascular injury (AV-001 specific biomarkers)	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.	Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)
Evaluate variations in cognitive assessment performance scores using Montreal Cognitive Assessment (MoCA)	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.	Study Visit Day 1 to Study Visit Day 3 (1 week)
Evaluate variations in cognitive assessment performance scores using Trailsmaking Test A	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.	Study Visit Day 1 to Study Visit Day 3 (1 week)
Trailsmaking B (TMTB)	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.	Study Visit Day 1 to Study Visit Day 3 (1 week)
Evaluate variations in cognitive performance scores using Creyos	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.	Study Visit Day 1 to Study Visit Day 3 (1 week)

Collaborators and Investigators

• Sponsor: London Health Sciences Centre Research Institute
• Collaborators: Vasomune Therapeutics, Inc.
• Investigators: Principal Investigator: Christopher W McIntyre, MD/PhD, London Health Science Centre

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 25, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 15976

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No