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

NCT03183245 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: CLN-PRO-V007
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 31

Brief Summary

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

Conditions

Renal Failure; End Stage Renal Disease; Hemodialysis; Vascular Access

Outcome Measures

Primary Outcomes (2)

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

  Co-primary endpoint #1: Proportion of subjects with functional patency at 6 months post study access (SA) creation The definition of "functional patency" is: Dialysis with "2 needles for ≥75% of dialysis sessions over a continuous 4-week period and either: (1) 4 consecutive sessions during the 4-week period in which 2 needles are used and the mean dialysis machine blood pump speed is ≥300 mL/min, or (2) a measured spKt/Vurea is ≥ 1.4 or urea reduction ratio \>70% during any session in which 2 needles are used within the 4-week period. SpKt/Vurea is calculated from pre and post-treatment serum urea nitrogen concentrations, body weight, and dialysis session duration." The functional patency ascertainment period will take place between the 1st day of Week 21 (Day 140) and the last day of Week 26 (Day 181) after AVF creation or HAV placement. The endpoint is met when the functional patency criteria are satisfied within any consecutive 4 week period within this ascertainment period.

  6 months post SA creation

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

  Co-primary endpoint #2: Proportion of subjects with secondary patency of SA at 12 months post SA creation. The SA maintains secondary patency until it is abandoned, irrespective of interventions to maintain or restore patency. Abandonment is defined as AVF or HAV that can no longer be used for 2-needle, prescribed dialysis as it may be unable to provide adequate flows and/or is deemed unsafe for the subject, and the associated problem cannot be corrected by any intervention, including medical, surgical, or radiological interventions or rest.

  12 months post SA creation

Secondary Outcomes (13)

• Time to loss of secondary patency (abandonment).

  12, 24, and 60 months post SA creation

• Incidence rate of HD access related interventions over the period from SA creation until SA abandonment or 12 months post SA creation

  12 months post SA creation

• Incidence rate of infections related to any HD access in situ over the period from SA creation until 12 months post SA creation, irrespective of SA abandonment.

  12 months post SA creation

• Proportion of subjects with unassisted functional patency at 6 months post SA creation.

  6 months post SA creation

• Incidence rate of HD access-related interventions over the period from SA creation until SA abandonment or the conclusion of the suitability ascertainment period (6 months).

  6 months post SA creation

Study Arms (2)

Human Acellular Vessel (HAV)

EXPERIMENTAL

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.

Biological: Human Acellular Vessel (HAV); Other: Hemodialysis

Arteriovenous fistula (AVF)

ACTIVE COMPARATOR

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

Procedure: Arteriovenous fistula (AVF); Other: Hemodialysis

Interventions

Human Acellular Vessel (HAV) BIOLOGICAL

Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

Human Acellular Vessel (HAV)

Arteriovenous fistula (AVF) PROCEDURE

Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

Arteriovenous fistula (AVF)

Hemodialysis OTHER

Procedure that filters a person's blood when their kidneys are no longer functioning properly

Arteriovenous fistula (AVF); Human Acellular Vessel (HAV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Humacyte, Inc.: lead
• CTI Clinical Trial and Consulting Services: collaborator
• California Institute for Regenerative Medicine (CIRM): collaborator

Study Sites (31)

Arizona Kidney Disease and Hypertension Center (AKDHC)

Phoenix, Arizona, 85012, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California, Irvine

Irvine, California, 92868, United States

Location

University of California San Diego, Jacobs Medical Center

La Jolla, California, 92103, United States

Location

University of CA, San Diego - LaJolla VA Hospital

La Jolla, California, 92161, United States

Location

Alliance Research

Laguna Hills, California, 92653, United States

Location

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

Huntington Hospital

Pasadena, California, 91105, United States

Location

UC Davis

Sacramento, California, 95817, United States

Location

Balboa Nephrology

San Diego, California, 92123, United States

Location

Mills Peninsula Hospital

San Mateo, California, 94401, United States

Location

Olive View- UCLA Medical Center

Sylmar, California, 91342, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

The Vascular Experts

Darien, Connecticut, 06820, United States

Location

Memorial Healthcare System

Pembroke Pines, Florida, 33021, United States

Location

Coastal Vascular & Interventional, PLLC

Pensacola, Florida, 32503, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

United Surgical Associates

Lexington, Kentucky, 40504, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Kidney Care & Transplant Services of New England

West Springfield, Massachusetts, 01089, United States

Location

Rutgers University

Newark, New Jersey, 07103, United States

Location

Overlook Medical Center

Summit, New Jersey, 07901, United States

Location

Surgical Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

Location

Kaiser Permanente Sunnsyide

Portland, Oregon, 97015, United States

Location

VA Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

The Regional Medical Center

Orangeburg, South Carolina, 29118, United States

Location

University of Tennessee Knoxville

Knoxville, Tennessee, 37920, United States

Location

South Plains Surgery Center

Lubbock, Texas, 79416, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

Interventions

Arteriovenous Shunt, Surgical; Renal Dialysis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Shamik Parikh, MD

  Humacyte, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: June 12, 2017
• Study Start: September 29, 2017
• Primary Completion: April 22, 2024
• Study Completion: June 19, 2025
• Last Updated: November 20, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)