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Synthetic Graft

HAV vs ePTFE Grafts for Hemodialysis Access in Kidney Failure

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
At least 18 years of age at Screening
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 12,18, 24, & 60 months post-implantation
Awards & highlights

Study Summary

This trial will compare the effects of using Human Acellular Vessels (HAV) vs ePTFE grafts for hemodialysis access.

Who is the study for?
Adults with end-stage renal disease (ESRD) needing hemodialysis access, who can't have an autologous AV fistula. They should have suitable anatomy for graft implantation, stable blood counts, and agree to use contraception if of childbearing potential. Excluded are those with severe vascular disease in the arm for implantation, active cancer treatment, certain blood disorders or infections.Check my eligibility
What is being tested?
The trial is testing whether a new type of vessel called Human Acellular Vessel (HAV) is better than the standard ePTFE graft used to create access points for hemodialysis in patients with chronic kidney failure.See study design
What are the potential side effects?
Potential side effects may include local complications at the site of surgery like infection or clotting, body's reaction to foreign material if any (immunological response), and typical surgical risks such as bleeding or pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Your arm has the right size and shape for the implantation of a straight or looped conduit, either in the forearm or upper arm, but not crossing the elbow.
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You have kidney failure and cannot have a certain type of blood vessel connection for hemodialysis.
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You are on hemodialysis or will need to start hemodialysis within 12 weeks of the study's procedure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12,18, 24, & 60 months post-implantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12,18, 24, & 60 months post-implantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Access-related infections
Anastomotic bleeding or rupture
Frequency and severity of AEs
+9 more

Side effects data

From 2023 Phase 2 trial • 15 Patients • NCT02887859
67%
Arthralgia, Back pain, Muscle necrosis, Musculoskeletal pain, Pain in extremity, Tenosynovitis
60%
Arterial stenosis, Haematoma, Intermittent claudication, Continued in description
60%
Anastomic stenosis, Arterial bypass stenosis, Arterial bypass thrombosis, continued in description
27%
Cough, Pleural effusion, Pulmonary mass
27%
Implant site extravasation, Peripheral swelling
27%
Impaired healing, Oedema peripheral, Pain, Vascular stent restenosis
27%
Bronchitis, Diverticulitis, Groin infection, Osteomyelitis, Rhinovirus infection
20%
Dizziness, Headache, Neuralgia
20%
Gout, Hyperuricaemia, Vitamin B12 deficiency
20%
Dermatitis, Skin hyperpigmentation, Skin ulcer
13%
Pleural effusion, Respiratory failure
13%
Angina pectoris, Coronary artery disease
13%
Anxiety, Insomnia
13%
Pulse absent, Scan myocardial perfusion abnormal
13%
Post procedural swelling, Seroma, Vascular pseudoaneurysm thrombosis, Wound decomposition
7%
Corona virus infection
7%
Lymphadenopathy
7%
Anemia
7%
Hyperglycaemic hyperosmolar nonketotic syndrome
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: ePTFEActive Control1 Intervention
The comparator (one of two commercially available 6mm ePTFE grafts) will be surgically implanted 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
604 Total Patients Enrolled
2 Trials studying Kidney Failure
270 Patients Enrolled for Kidney Failure
CTI Clinical Trial and Consulting ServicesOTHER
34 Previous Clinical Trials
3,380 Total Patients Enrolled
3 Trials studying Kidney Failure
363 Patients Enrolled for Kidney Failure
California Institute for Regenerative Medicine (CIRM)OTHER
63 Previous Clinical Trials
2,793 Total Patients Enrolled
1 Trials studying Kidney Failure
240 Patients Enrolled for Kidney Failure

Media Library

Kidney Failure Research Study Groups: Human Acellular Vessel (HAV), ePTFE

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the use of HAV for medical procedures backed by the FDA?

"HAV's safety is rated highly by our team at Power, who gave it a score of 3. This is because it is a Phase 3 trial, which means that not only is there some data supporting its efficacy, but multiple rounds of data supporting its safety."

Answered by AI

What are the most similar tests that have been completed using Human Acellular Vessels (HAV)?

"HAV was first trialled in 2016 at Leicester General. There have been 7 completed clinical trials to date, with the most recent ones being based out of Greenwood, Mississippi."

Answered by AI

What makes this experiment unique compared to others like it?

"First studied in 2016, HAV has progressed through the clinical trial process and is now in Phase 3. There are currently 6 active trials being conducted in 69 cities and 8 countries."

Answered by AI

Are there any unfilled participant positions for this experiment?

"According to information available on clinicaltrials.gov, this particular trial is not currently looking for new patients. This study was first posted on May 24th, 2016 and was last updated on August 18th, 2022. There are, however, 259 other trials that are accepting patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis
2016. "Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02644941.
~40 spots leftby Apr 2025
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