Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis

Completed · Phase 3

Conditions studied: Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access

In brief

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

Key facts

Study ID: NCT03183245
Run by: Humacyte, Inc.
People needed: 242
Starts: 2017-09-29
Expected to finish: 2025-06-19
Last updated by the study team: 2025-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitable for the creation of an AVF or implantation of AVG for HD access.
Subjects who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 6 months after SA creation.
Subjects aged at least 18 years at Screening.
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.
Hemoglobin ≥8 g/dL and platelet count ≥100,000 /mm3.
International Normalized Ratio (INR) ≤ 1.5.
Female subjects must be either:
Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).
Or, of childbearing potential, in which case:
i. Must have a negative urine or serum pregnancy test at Screening, and ii. Must agree to use at least one form of the following birth control methods for the duration of the study:
Established use of oral, injectable or implanted hormonal methods of contraception.
Placement of an intrauterine device or intrauterine system.
Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.
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.
Life expectancy of at least 2 years.

You may not qualify if…

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.
Uncontrolled diabetes;
a. HbA1c >10% (at Screening).
History or evidence of severe peripheral arterial disease in the extremity selected for implant.
Known or suspected central vein stenosis or obstruction on the side of planned SA creation, unless corrected prior to randomization.
Planned AVF creation that requires more than one stage to complete. (e.g. basilic vein transposition AVF performed in 2 stages).
Planned AVF creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices).
Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product.
Cancer that is actively being treated with a cytotoxic agent.
Documented hyper-coagulable state.
Bleeding diathesis.
Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
Low dose glucocorticoid therapy (e.g. 5-10mg prednisone [Deltason]) is acceptable.
High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
tacrolimus or FK506 [Prograf]

Where it is running

Arizona Kidney Disease and Hypertension Center (AKDHC) — Phoenix, Arizona, United States
University of Arizona — Tucson, Arizona, United States
University of California, Irvine — Irvine, California, United States
University of California San Diego, Jacobs Medical Center — La Jolla, California, United States
University of CA, San Diego - LaJolla VA Hospital — La Jolla, California, United States
Alliance Research — Laguna Hills, California, United States
VA Long Beach Healthcare System — Long Beach, California, United States
University of Southern California — Los Angeles, California, United States
Huntington Hospital — Pasadena, California, United States
UC Davis — Sacramento, California, United States
Balboa Nephrology — San Diego, California, United States
Mills Peninsula Hospital — San Mateo, California, United States
Olive View- UCLA Medical Center — Sylmar, California, United States
Denver Health Medical Center — Denver, Colorado, United States
The Vascular Experts — Darien, Connecticut, United States
Memorial Healthcare System — Pembroke Pines, Florida, United States
Coastal Vascular & Interventional, PLLC — Pensacola, Florida, United States
Tampa General Hospital — Tampa, Florida, United States
Grady Memorial Hospital — Atlanta, Georgia, United States
Decatur Memorial Hospital — Decatur, Illinois, United States
United Surgical Associates — Lexington, Kentucky, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
Kidney Care & Transplant Services of New England — West Springfield, Massachusetts, United States
Rutgers University — Newark, New Jersey, United States
Overlook Medical Center — Summit, New Jersey, United States

Full record on ClinicalTrials.gov

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