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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Ability to provide informed consent
• Male and non-pregnant female patients (\>18 years old)
• HD for ≥ 3 months
• Thrice weekly HD schedule
Locations
Other Locations
Canada
London Health Sciences Centre
RECRUITING
London
Contact Information
Primary
Jarrin D Penny, PhD, RN
jarrin.penny@lhsc.on.ca
519-685-8500
Backup
Kathy Koyle
kathleen.koyle@lhsc.on.ca
519-685-8500
Time Frame
Start Date: 2025-12-16
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: London Health Sciences Centre Research Institute
Collaborators: Vasomune Therapeutics, Inc.