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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12, 24, and 60 months post sa creation
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12, 24, and 60 months post sa creation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12, 24, and 60 months post sa creation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
Frequency and severity of AEs.
Histopathological remodeling of HAV and AVF - based on histological examination of SA samples explanted for clinical reasons
Incidence rate of HD access related interventions over the period from SA creation until SA abandonment or 12 months post SA creation
+10 moreSide effects data
From 2023 Phase 2 trial • 15 Patients • NCT0288785967%
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%
Implant site extravasation, Peripheral swelling
27%
Bronchitis, Diverticulitis, Groin infection, Osteomyelitis, Rhinovirus infection
27%
Impaired healing, Oedema peripheral, Pain, Vascular stent restenosis
20%
Dizziness, Headache, Neuralgia
20%
Gout, Hyperuricaemia, Vitamin B12 deficiency
20%
Dermatitis, Skin hyperpigmentation, Skin ulcer
13%
Post procedural swelling, Seroma, Vascular pseudoaneurysm thrombosis, Wound decomposition
13%
Pleural effusion, Respiratory failure
13%
Angina pectoris, Coronary artery disease
13%
Anxiety, Insomnia
13%
Pulse absent, Scan myocardial perfusion abnormal
7%
Corona virus infection
7%
Hyperglycaemic hyperosmolar nonketotic syndrome
7%
Lymphadenopathy
7%
Anemia
7%
Gastrointestinal hemorrhage
7%
Acute kidney injury
7%
Arterial insufficiency
7%
Nausea
7%
Cholecystitis
7%
Renal cyst
7%
Cardiac failure acute
7%
Adenocarcinoma of colon
100%
80%
60%
40%
20%
0%
Study treatment Arm
HAV 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
Find a Location
Who is running the clinical trial?
Humacyte, Inc.Lead Sponsor
10 Previous Clinical Trials
719 Total Patients Enrolled
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385 Patients Enrolled for Vascular Access
California Institute for Regenerative Medicine (CIRM)OTHER
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2,908 Total Patients Enrolled
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355 Patients Enrolled for Vascular Access
CTI Clinical Trial and Consulting ServicesOTHER
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3,495 Total Patients Enrolled
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking any immune-suppressing drugs like tacrolimus, mycophenolate mofetil, cyclosporine, or sirolimus.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.You have a specific type of blood vessel that is suitable for a certain kind of procedure, based on several measurements and tests.You have experienced a condition called heparin-induced thrombocytopenia in the past.The vein used for the study cannot be located closer to the center of the body than the vein used for any previous unsuccessful access in that arm.You have a serious allergy or intolerance to aspirin or other medications that prevent blood from clotting.I can communicate well, agree to participate, and can follow the study plan.I am 18 years old or older.I don't have or have treated any vein blockages where my surgical access is planned.I am scheduled for a special procedure to create a fistula for dialysis that doesn't use stitches or clips.I have a bleeding disorder.I do not currently have an infection, or if I did, it has been resolved for at least a week.I plan to have hemodialysis at a participating center for at least 6 months after creating a surgical access.I haven't used any experimental drugs or devices in the last 60 days.I have an active immune disease not controlled by low-dose medication.I am expected to have a kidney transplant within the next 6 months.I am not able to have children, or I will use birth control during the study.I have severe artery problems in the limb where the implant will be placed.You have a medical record showing a condition that makes your blood more likely to clot.I am scheduled for a multi-stage procedure to create a fistula for dialysis.Your diabetes is not well controlled, with a high HbA1c level above 10%.I have severe kidney disease and am on dialysis, suitable for a new dialysis access.You are expected to live for at least 2 more years.I am currently receiving chemotherapy for my cancer.Any other health condition that the investigator thinks would make it difficult to measure how safe and effective the study treatment is for you.
Research Study Groups:
This trial has the following groups:- Group 1: Human Acellular Vessel (HAV)
- Group 2: Arteriovenous fistula (AVF)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Human Acellular Vessel (HAV) for use?
"There is both anecdotal and clinical evidence in support of Human Acellular Vessels (HAVs), thus we rate its safety as a 3."
Answered by AI
Are there other ongoing or previously completed studies that have used Human Acellular Vessels (HAV)?
"HAV was first studied in Leicester General Hospital in 2016 and there have been 7 completed trials to date. Right now, there are 6 ongoing clinical trials with a significant presence in Darien, Connecticut."
Answered by AI
Where are patients able to receive this treatment?
"30 different medical facilities are currently running this trial; however, it may be more convenient for you to enroll at the location nearest to you to minimize travel. The 30 sites are located in Darien, West Springfield, Decatur and other locations."
Answered by AI
How many research subjects are included in the current iteration of this experiment?
"In order to proceed, this clinical study requires the recruitment of 240 participants that meet the specific inclusion criteria. These patients can come from different medical facilities, such as The Vascular Experts in Darien, Connecticut and Kidney Care & Transplant Services of New England in West Springfield, Massachusetts."
Answered by AI
Are new participants being brought in for this experiment?
"Yes, this trial is open and recruiting patients. The original posting was on September 29th, 2017, with the most recent update on August 18th, 2022."
Answered by AI
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