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Vascular Access Device

HAV vs AVF for Hemodialysis Access

Phase 3

Waitlist Available

Research Sponsored by Humacyte, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight or looped HAV in either the forearm or upper arm.

Subject, or legal representative, able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.

Must not have

The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial: tacrolimus or FK506 [Prograf], mycophenolate mofetil [Cellcept], cyclosporine [Sandimmune or Gengraf], sirolimus [Rapamune] (this only includes systemically administered, drug eluting stents are acceptable).

Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL of the following criteria: No previous failed AVF, Cephalic vein diameter on ultrasound of more than 3.5mm, Radial artery diameter on ultrasound of more than 3mm, Vein depth of less than 0.5cm from the skin, Normal Allen's test indicating that ulnar artery flow to the hand is sufficient, No calcification in the wall of the distal radial artery, Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment, No evidence of iatrogenic injury to target artery or vein.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post sa creation

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is comparing the two most common types of hemodialysis access: Human Acellular Vessel (HAV) and arteriovenous fistula (AVF).

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include complications at the site where HAV or AVF is created such as infection, clotting issues, bleeding problems, or vessel narrowing that could affect dialysis treatment effectiveness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can communicate well, agree to participate, and can follow the study plan.

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I am 18 years old or older.

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I plan to have hemodialysis at a participating center for at least 6 months after creating a surgical access.

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I have severe kidney disease and am on dialysis, suitable for a new dialysis access.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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You have a specific type of blood vessel that is suitable for a certain kind of procedure, based on several measurements and tests.

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I don't have or have treated any vein blockages where my surgical access is planned.

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I am scheduled for a special procedure to create a fistula for dialysis that doesn't use stitches or clips.

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I haven't used any experimental drugs or devices in the last 60 days.

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I have a bleeding disorder.

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I have an active immune disease not controlled by low-dose medication.

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I am expected to have a kidney transplant within the next 6 months.

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I have severe artery problems in the limb where the implant will be placed.

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I am scheduled for a multi-stage procedure to create a fistula for dialysis.

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I am currently receiving chemotherapy for my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post sa creation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post sa creation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post sa creation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of subjects with functional patency at 6 months post study access (SA) creation

Proportion of subjects with secondary patency of SA at 12 months post SA creation.

Side effects data

From 2023 Phase 2 trial • 15 Patients • NCT02887859

67%

Arthralgia, Back pain, Muscle necrosis, Musculoskeletal pain, Pain in extremity, Tenosynovitis

60%

Anastomic stenosis, Arterial bypass stenosis, Arterial bypass thrombosis, continued in description

60%

Arterial stenosis, Haematoma, Intermittent claudication, Continued in description

27%

Cough, Pleural effusion, Pulmonary mass

27%

Bronchitis, Diverticulitis, Groin infection, Osteomyelitis, Rhinovirus infection

27%

Impaired healing, Oedema peripheral, Pain, Vascular stent restenosis

27%

Implant site extravasation, Peripheral swelling

20%

Gout, Hyperuricaemia, Vitamin B12 deficiency

20%

Dermatitis, Skin hyperpigmentation, Skin ulcer

20%

Dizziness, Headache, Neuralgia

13%

Pleural effusion, Respiratory failure

13%

Pulse absent, Scan myocardial perfusion abnormal

13%

Angina pectoris, Coronary artery disease

13%

Anxiety, Insomnia

13%

Post procedural swelling, Seroma, Vascular pseudoaneurysm thrombosis, Wound decomposition

Adenocarcinoma of colon

Arterial insufficiency

Anemia

Lymphadenopathy

Cardiac failure acute

Gastrointestinal hemorrhage

Corona virus infection

Cholecystitis

Renal cyst

Nausea

Hyperglycaemic hyperosmolar nonketotic syndrome

Acute kidney injury

100%

80%

60%

40%

20%

Study treatment Arm

HAV Treatment

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Human Acellular Vessel (HAV)Experimental Treatment1 Intervention

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 Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Human Acellular Vessel (HAV)

2016

Completed Phase 3

~370

0 / 16Eligibility criteria met