AV-001 to Prevent Brain Injury from Hemodialysis
Official 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
Run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT07234890 · Data updated 2026-11-12
This study will test whether giving AV-001 before dialysis can protect the brains of adults on regular hemodialysis by strengthening blood vessels and reducing inflammation.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Status | Recruiting |
| Started | December 16, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT07234890 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults (≥18) who have been on thrice-weekly hemodialysis for at least three months, can give informed consent, and do not have severe cognitive impairment, prior stroke, or MRI contraindications.
✕Probably not a fit
People with established severe cognitive impairment or a history of clinical stroke, those unable to undergo MRI, pregnant or breastfeeding individuals, and patients on dialysis for less than three months are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2 exploratory trial will enroll 60 adults receiving thrice-weekly hemodialysis at London Health Sciences Centre. Participants will receive low-dose AV-001, high-dose AV-001, or placebo 60 minutes before three dialysis sessions during one week. Investigators will collect vital signs, blood samples, cognitive assessments, vascular ultrasound, and brain MRI to look for signs of dialysis-related brain injury and inflammation. The main goal is to see whether AV-001 produces short-term vascular and neuroprotective effects on imaging and cognitive measures.
Why it matters
Potential benefit: If successful, AV-001 could reduce dialysis-related brain injury and lower the risk of cognitive decline and stroke in people on maintenance hemodialysis.
How similar studies have gone: The strategy of protecting cerebral vessels and reducing inflammation has some support from preclinical and early-phase work, but AV-001 has limited clinical evidence in hemodialysis patients and this approach remains largely unproven in this population.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
London Health Sciences Centre
London, Ontario, Canada Recruiting
Study contacts
- Principal investigator: Christopher W McIntyre, MD/PhD — London Health Science Centre
- Study coordinator: Jarrin D Penny, PhD, RN
- Email: jarrin.penny@lhsc.on.ca
- Phone: 519-685-8500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.