AV-001 to Prevent Brain Injury from Hemodialysis
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
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT07234890 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
London, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.