Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AV-001 or Placebo Injection.
- Who it may be relevant to
- Registry conditions: Hemodialysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Detailed description
Hemodialysis provides life-sustaining treatment for many chronic kidney disease patients around the world. Moderate to severe cognitive impairment is very common in HD patients with up to 70% being affected who are ≥ 55 years of age and \~ 10% in those between 21-39 years of age. Significant cognitive impairment is evident within 6 months of starting HD.
This study is a phase 2 exploratory study in patients receiving hemodialysis treatments. Investigators will recruit 60 patients from the renal program at the London Health Sciences Centre.
Study participants will receive AV-001 (low or high dose) or placebo 60 minutes prior to HD initiation at 3 HD treatment sessions within 1 week (Monday, Wednesday and Friday)
Study participants will also undergo:
* Vital sign collection (blood pressure and heart rate) * Blood collection * Cognitive assessments * Vascular ultrasound * MRI
Interventions
- Drug AV-001 or Placebo Injection
AV-001 or Placebo administered via IV bolus injection.
Primary outcome measures
- 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.]
Secondary outcome measures (12)
- Evaluate circulating biomarkers of vascular injury (S-100β ) [Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (transthyretin) [Time frame: Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (TNF-a) [Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (IL-6) [Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (serum lipopolysaccharide) [Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (complete blood count) [Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (urea) [Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (electrolytes) [Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate circulating biomarkers of vascular injury (dialysate composition) [Time frame: Study Visit Day 1 to Study Visit Day 3 (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (Clot) [Time frame: Study visit Day 1 to Study Visit Day 3 (over a 1-week period)]
- Evaluate circulatory biomarkers of vascular injury (AV-001 specific biomarkers) [Time frame: Study Visit Day 1 to Study Visit Day 3. (over a 1-week period)]
- Evaluate variations in cognitive assessment performance scores using Montreal Cognitive Assessment (MoCA) [Time frame: Study Visit Day 1 to Study Visit Day 3 (1 week)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Health services research
Study locations
Canada · 1 center
- London Health Sciences Centre — London
Identifiers
NCT: NCT07234890 · 15976