Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-Blind, Placebo Controlled, Exploratory Group 1 (N-20) Placebo Group 2 (N-20) AV-001 Low dose Group 3 (N-20) Av-001 High dose

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

AV-001 or Placebo Injection

Intervention Type DRUG

AV-001 or Placebo administered via IV bolus injection.

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.

Group Type EXPERIMENTAL

AV-001 or Placebo Injection

Intervention Type DRUG

AV-001 or Placebo administered via IV bolus injection.

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.

Group Type EXPERIMENTAL

AV-001 or Placebo Injection

Intervention Type DRUG

AV-001 or Placebo administered via IV bolus injection.

Interventions

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AV-001 or Placebo Injection

AV-001 or Placebo administered via IV bolus injection.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No