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

NCT07234890 | Recruiting Phase 2

• 1 other identifier: 15976
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  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 Outcomes (15)

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

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

• Evaluate circulatory biomarkers of vascular injury (transthyretin)

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

• Evaluate circulatory biomarkers of vascular injury (TNF-a)

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

• Evaluate circulatory biomarkers of vascular injury (IL-6)

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

• Evaluate circulatory biomarkers of vascular injury (serum lipopolysaccharide)

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

Study Arms (3)

Group 1 Placebo

EXPERIMENTAL

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

Group 2: AV-001 low dose (12.5μg/kg)

EXPERIMENTAL

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

Group 3: AV-001 High Dose (25μg/kg)

EXPERIMENTAL

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

Interventions

AV-001 or Placebo Injection DRUG

AV-001 or Placebo administered via IV bolus injection.

Group 1 Placebo; Group 2: AV-001 low dose (12.5μg/kg); Group 3: AV-001 High Dose (25μg/kg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability to provide informed consent
• Male and non-pregnant female patients (\>18 years old)
• HD for ≥ 3 months
• Thrice weekly HD schedule

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute: lead
• Vasomune Therapeutics, Inc.: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Study Officials

• Christopher W McIntyre, MD/PhD

  London Health Science Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jarrin D Penny, PhD, RN

CONTACT

519-685-8500; jarrin.penny@lhsc.on.ca

Kathy Koyle

CONTACT

519-685-8500; kathleen.koyle@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MBBS DM

Model Details: Double-Blind, Placebo Controlled, Exploratory Group 1 (N-20) Placebo Group 2 (N-20) AV-001 Low dose Group 3 (N-20) Av-001 High dose

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: November 19, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CA (1)