HAV vs AVF for Hemodialysis Access

Recruiting at 30 trial locations

Overseen By Mark Tulchinskiy, MD, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Humacyte, Inc.

Must not be taking: Immunosuppressants, Cytotoxic agents

Disqualifiers: Uncontrolled diabetes, Peripheral arterial disease, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 24 months

240 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, certain medications like high-dose glucocorticoids and specific immunosuppressive agents are not allowed during the trial.

What data supports the effectiveness of the treatment Arteriovenous fistula (AVF) for Hemodialysis Access?

Research shows that arteriovenous fistulas (AVF) are the preferred choice for hemodialysis access because they have lower complication rates and last longer compared to other options like grafts and catheters. ^{1 2 3 4 5}

Is the Human Acellular Vessel (HAV) safe for use in hemodialysis access surgery?

The Human Acellular Vessel (HAV) has been used in complex vascular access surgeries and aneurysm repairs with technical success, especially in high-risk patients who had no other care options. This suggests it may be a safe option for hemodialysis access, although it was used under special circumstances with FDA authorization. ^{1 2 3 6 7}

How is the treatment with Human Acellular Vessel (HAV) different from other treatments for hemodialysis access?

The Human Acellular Vessel (HAV) is unique because it is a biocompatible, regenerative medicine conduit used when traditional arteriovenous fistulas (AVFs) are not viable due to complications like aneurysms or infections. Unlike standard AVFs, HAVs offer a promising alternative for patients with complex vascular needs, potentially improving safety and effectiveness in high-risk cases. ^{1 2 3 6 8}

What is the purpose of this trial?

The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access

Research Team

Shamik Parikh, MD

Principal Investigator

Humacyte, Inc.

Eligibility Criteria

This trial is for adults with end-stage renal disease who are on hemodialysis and suitable for a new forearm or upper arm vascular access. They should not have certain blood conditions, active cancer treatments, severe allergies to aspirin, uncontrolled diabetes, or be pregnant. Participants must agree to use contraception if applicable and have a life expectancy of at least 2 years.

Inclusion Criteria

My arm's structure allows for a specific type of vascular access creation.

Your hemoglobin level is at least 8 grams per deciliter and your platelet count is at least 100,000 per cubic millimeter.

Your blood clotting test result (INR) should be less than 1.5.

Exclusion Criteria

I am not taking any immune-suppressing drugs like tacrolimus, mycophenolate mofetil, cyclosporine, or sirolimus.

Previous enrollment in this study or any other study with HAV.

Employees of Humacyte and employees or relatives of an investigator.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

6 weeks

1 visit (in-person)

Treatment

Participants receive either a Human Acellular Vessel (HAV) or an arteriovenous fistula (AVF) for hemodialysis access

24 months

Routine study visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Routine study visits

Treatment Details

Interventions

• Arteriovenous fistula (AVF)
• Human Acellular Vessel (HAV)

Trial Overview The study compares two methods used to create access for hemodialysis: the Human Acellular Vessel (HAV) and the traditional arteriovenous fistula (AVF). The goal is to see which one works better as a conduit for dialysis in patients with kidney failure.

Participant Groups

Group I: Human Acellular Vessel (HAV) Experimental Treatment 2 Interventions

The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. It will be surgically implanted in the forearm or upper arm on Study Day 0.

Group II: Arteriovenous fistula (AVF) Active Control 2 Interventions

The comparator is an autologous arteriovenous fistula created in the forearm or upper arm on Study Day 0.

Who Is Running the Clinical Trial?

Humacyte, Inc.

Lead Sponsor

Trials

11

Recruited

960+

California Institute for Regenerative Medicine (CIRM)

Collaborator

Trials

70

Recruited

3,300+

CTI Clinical Trial and Consulting Services

Collaborator

Trials

36

Recruited

3,700+

Findings from Research

In a study of 532 hemodialysis patients followed for a median of 28 months, those using arteriovenous fistulas (AVF) had significantly lower mortality rates compared to those using central venous catheters (CVC), with a hazard ratio of 1.58 after adjustments for other factors.

The research identified that older age, female gender, and higher comorbidity scores were associated with a higher likelihood of using non-AVF access methods, highlighting the importance of promoting AVF use to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodialysis vascular access and clinical outcomes: an observational multicenter study. Soleymanian, T., Sheikh, V., Tareh, F., et al.[2017]

In a study of 2200 patients, arteriovenous fistulas (AVF) showed better survival benefits and vascular access (VA) patency compared to arteriovenous grafts (AVG) in patients under 80 years old, particularly in those aged 70-79.

For patients aged 80 and older, both AVF and AVG demonstrated similar patency rates, indicating that the advantages of AVF may diminish in this older age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of vascular access patency and patient survival between native arteriovenous fistula and synthetic arteriovenous graft according to age group. Choi, J., Ban, TH., Choi, BS., et al.[2021]

The use of human acellular vessels (HAV) as a conduit for vascular access in hemodialysis shows promise in improving safety and efficacy for patients with end-stage renal disease, particularly in complex cases where standard options are limited.

In a high-risk population with significant comorbidities, the technical success of surgeries using HAV for aneurysm repairs suggests that this regenerative medicine approach could expand treatment options for patients needing vascular access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair. Nickerson, MC., Thamba, A., Rao, V., et al.[2023]

In a study of 205 patients undergoing hemodialysis, the use of hemodialysis catheters (KT) was primarily for waiting on arteriovenous fistula (AVF) creation, with a notable 39.2% infection rate linked to prolonged use and low hemoglobin levels, although antiseptic locks significantly reduced infection risk.

The study found that AVF complications, such as thrombosis and aneurysm, were common, with diabetes and obesity being significant risk factors; however, antiplatelet therapy was shown to improve AVF patency, highlighting the need for timely AVF creation and better management of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolutive profile of hemodialysis vascular accesses Hemodialysis accesses. Gorsane, I., Chermiti, M., Mechri, E., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hemodialysis vascular access and clinical outcomes: an observational multicenter study. [2017]

2. Canada pubmed.ncbi.nlm.nih.gov

Comparison of vascular access patency and patient survival between native arteriovenous fistula and synthetic arteriovenous graft according to age group. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Medicare Costs Associated With Arteriovenous Fistulas Among US Hemodialysis Patients. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Creating arteriovenous fistulas using surgeon-performed ultrasound. [2017]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of Outcomes with Arteriovenous Fistula and Arteriovenous Graft for Vascular Access in Hemodialysis: A Prospective Cohort Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Patency Outcomes of Arteriovenous Fistulas and Grafts for Hemodialysis Access: A Trade-Off between Nonmaturation and Long-Term Complications. [2022]

8. Tunisia pubmed.ncbi.nlm.nih.gov

Evolutive profile of hemodialysis vascular accesses Hemodialysis accesses. [2022]