NCT07234890 Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.
| NCT ID | NCT07234890 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | London Health Sciences Centre Research Institute |
| Condition | Hemodialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-16 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-12-16 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Christopher W McIntyre, MD/PhD
PRINCIPAL INVESTIGATOR
London Health Science Centre
Frequently Asked Questions
Who can join the NCT07234890 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hemodialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07234890 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07234890 currently recruiting?
Yes, NCT07234890 is actively recruiting participants. Contact the research team at jarrin.penny@lhsc.on.ca for enrollment information.
Where is the NCT07234890 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT07234890 clinical trial?
NCT07234890 is sponsored by London Health Sciences Centre Research Institute. The principal investigator is Christopher W McIntyre, MD/PhD at London Health Science Centre. The trial plans to enroll 60 participants.