Recruiting
Phase 2

AV-001

Sponsor:

London Health Sciences Centre Research Institute

Code:

NCT07234890

Conditions

Hemodialysis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AV-001 or Placebo Injection

Study Details

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

Study ID

NCT07234890

Start date

Dec 16, 2025

Status verified date

Apr, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

AV-001 or Placebo Injection

AV-001 or Placebo administered via IV bolus injection.

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Jarrin D Penny, PhD, RN

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

Kathy Koyle

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

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

Jarrin Penny, PhD, RN

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

Kathy Koyle

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

Principal Investigator:

Christopher McIntyre, MBBS DM

More Information

Sponsor

London Health Sciences Centre Research Institute

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute on 2026-04-17.