Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.
ConditionHemodialysis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Ability to provide informed consent
Male and non-pregnant female patients (>18 years old)
HD for ≥ 3 months
Thrice weekly HD schedule
Disqualifiers
HD <90 days
Contraindication to MRI
Established severe cognitive impairment (Montreal Cognitive Assessment test (MoCA) <18 or formal diagnosis of dementia)
Previous clinical stroke
Trial design
Design model
Parallel
Treatments tested in this trial
AV-001 or Placebo Injection
DrugAV-001 or Placebo administered via IV bolus injection.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Group 1 PlaceboExperimental treatment 1 intervention
Group B: Group 2: AV-001 low dose (12.5μg/kg)Experimental treatment 1 intervention
Group C: Group 3: AV-001 High Dose (25μg/kg)Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Before and after dialysis on study visit day 3.Secondary outcomes
1
Evaluate circulating biomarkers of vascular injury (S-100β )
Blood Samples (S-100β) will be collected Pre-HD, Peak-HD and Post HD for analysis.
Time frame
Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)2
Evaluate circulatory biomarkers of vascular injury (transthyretin)
Blood samples (transthyretin) will be collected Pre-HD, Peak HD and Post HD for analysis.
Time frame
Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)3
Evaluate circulatory biomarkers of vascular injury (TNF-a)
Blood Samples (TNF-a) will be collected Pre-HD, Peak-HD and Post HD for analysis
Time frame
Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)4
Evaluate circulatory biomarkers of vascular injury (IL-6)
Blood samples (IL-6) will be collected Pre-HD, Peak-HD and Post HD for analysis
Time frame
Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
London Health Sciences Centre Research Institute
Lead sponsor
Vasomune Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov