HAV vs AVF for Hemodialysis Access

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods for creating access for hemodialysis in patients with end-stage kidney disease. Researchers are testing a new type of blood vessel, the Human Acellular Vessel (HAV), against the traditional arteriovenous fistula (AVF) to determine which is more effective. Patients with end-stage kidney disease currently using a catheter for dialysis might find this trial suitable. As a Phase 3 trial, this study is the final step before FDA approval, offering participants the chance to contribute to potentially groundbreaking advancements in dialysis treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Human Acellular Vessel (HAV) has been tested in patients with severe kidney disease requiring dialysis. Studies have found that HAV provides a reliable way to access the bloodstream for dialysis. In these studies, most patients tolerated HAV well. Although some side effects occurred, serious issues were rare.

Since this trial is in a later stage, evidence already suggests that HAV is safe for people. HAV has undergone testing for several years, providing some confidence in its safety for use in dialysis. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Human Acellular Vessel (HAV) for hemodialysis access because it offers a unique, tissue-engineered alternative to traditional methods like the arteriovenous fistula (AVF). Unlike AVFs, which use the patient's own blood vessels, HAVs are bioengineered to reduce the risk of complications and improve long-term durability. This innovative approach could potentially enhance the quality of life for patients with end-stage renal disease by providing a more reliable and possibly safer option for hemodialysis access.

What evidence suggests that this trial's treatments could be effective for hemodialysis access?

This trial will compare the Human Acellular Vessel (HAV) with the arteriovenous fistula (AVF) for hemodialysis access. Research has shown that the HAV can be a good option for creating a dialysis access point in patients with severe kidney disease. Studies have found that HAV provides a strong and effective way to access dialysis, with successful results lasting over five years. This durability makes HAV a promising choice compared to traditional methods. While the AVF is commonly used, HAV offers a specially designed solution that might suit those needing long-term dialysis access. ^{1 2 3 5 6}

Who Is on the Research Team?

Shamik Parikh, MD

Principal Investigator

Humacyte, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8881722/

Five Year Outcomes in Patients with End Stage Renal ... Conclusion. This phase II long term follow up shows that the human acellular vessel (HAV) may provide durable and functional haemodialysis access for patients ...

2. journals.lww.com journals.lww.com/jasn/fulltext/2021/10001/five_year_outcome_in_patients_with_esrd_who.820.aspx

Five-Year Outcome in Patients with ESRD Who Received ... Conclusions: This long-term follow up shows that the HAV provides durable and functional hemodialysis access for patients with end-stage renal disease who ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02644941

Comparison of the Human Acellular Vessel (HAV) With ... The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03183245

Study Details | NCT03183245 | Comparison of the Human ... The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35243473/

Five Year Outcomes in Patients with End Stage Renal ... Conclusion: This phase II long term follow up shows that the human acellular vessel (HAV) may provide durable and functional haemodialysis ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04135417

Safety and Efficacy Assessment of HAV in Patients ... The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. HAV for this study will be ...