HAV vs AVF for Hemodialysis Access

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Humacyte, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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.

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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.

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Treatment Details

Interventions

Arteriovenous fistula (AVF) (Vascular Access Device)
Human Acellular Vessel (HAV) (Vascular Access Device)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Active Control

Group I: Human Acellular Vessel (HAV)Experimental Treatment2 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 Control2 Interventions

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