To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis (HUMAXX)

A Phase 3 Randomized Study to Compare the Efficacy and Safety of the Humacyte Acellular Tissue Engineered Vessel (ATEV) With That of an Autogenous Arteriovenous Fistula (AVF) in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the ATEV and AVF groups over 12 months in patients with end-stage renal disease (ESRD) needing hemodialysis (HD).

Participants will be stratified by location of the vascular access (forearm versus upper arm) and by type of AVF creation procedure planned by the surgeon at randomization (1-stage AVF versus 2-stage AVF). The comparator is an upper extremity arterio-venous fistula (AVF) for HD access surgically created per the institution's Standard of Care (SoC).

Study Overview

• Status: Recruiting
• Conditions: End Stage Renal Disease (ESRD)
• Intervention / Treatment: Other: AVF; Biological: Acellular Tissue Engineered Vessel (ATEV)

Detailed Description

This is a prospective, multicenter, randomized, two-arm, comparative Phase 3 study of female patients with ESRD, who are receiving clinically successful hemodialysis (HD) via a central venous dialysis catheter (DC).

Approximately 150 female patients will be randomized 1:1 to either the ATEV or the AVF treatment arm. Patients will be stratified by location of the vascular access (forearm versus upper arm) and by type of AVF creation procedure planned by the surgeon at randomization (1-stage AVF versus 2-stage AVF).

All patients will be followed through Month 12 regardless of SA patency status. Patients who have a patent SA at Month 12 will then be followed in the Long-Term Extension study for an additional 12 months with evaluation of exploratory long-term endpoints.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

• Study Contact: Name: Elizabeth Taylor; Phone Number: 185 919.313.9633; Email: etaylor@humacyte.com
• Study Contact Backup: Name: Jordanna Foster; Phone Number: 919.313.9633; Email: jfoster@humacyte.com

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Recruiting
      • Honor Health Scottsdale Shea Medical Center
      • Contact: Hasan Aldailami, MD
  • California
    • El Centro, California, United States, 92243
      • Recruiting
      • El Centro Regional Medical Center
      • Contact: Luis Cajas-Monson, MD
    • La Jolla, California, United States, 92037
      • Recruiting
      • Jacob's Medical Center at UC San Diego Health
      • Contact: Mahmoud Malas, MD
  • Colorado
    • Denver, Colorado, United States, 80204
      • Recruiting
      • Denver Health and Hospital Authority
      • Contact: Ernest Moore, MD
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Recruiting
      • Yale New Haven Hospital
      • Contact: Cassius Chaar, MD
  • Florida
    • Brooksville, Florida, United States, 34613
      • Recruiting
      • Access Research Institute
      • Contact: Lyle Breeding, MD
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • University of FL Health Heart and Vascular Hospital
      • Contact: Samir Shah, MD
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida
      • Contact: Young Erben, MD
    • Miami, Florida, United States, 33156
      • Recruiting
      • American Access Care of Miami, LLC
      • Contact: Jose Ramirez, MD
    • Tampa, Florida, United States, 33606
      • Recruiting
      • USF Health South Tampa
      • Contact: Aurelia Calero, MD
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Recruiting
      • Grady Memorial Hospital
      • Contact: Manuel Garcia-Toca, MD
    • Atlanta, Georgia, United States, 30046
      • Recruiting
      • Georgia Nephrology
      • Contact: James Tumlin, MD
  • Indiana
    • Bloomington, Indiana, United States, 47408
      • Recruiting
      • IU health Bloomington Hospital
      • Contact: David Peterson, MD
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • John Hopkins University School of Medicine
      • Contact: Ying Wei Lum, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
      • Contact: Mohamad Hussain, MD
    • Boston, Massachusetts, United States, 02118
      • Recruiting
      • Boston Medical Center
      • Contact: Jeffrey Siracuse, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Karthik Ramani, MD
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Recruiting
      • Rutgers University_Medical
      • Contact: Michael Curi, MD
    • Paterson, New Jersey, United States, 07503
      • Recruiting
      • St.Joseph's University Medical Center
      • Contact: John Danks, MD
    • Pennington, New Jersey, United States, 08534
      • Recruiting
      • Capital Health Medical Center- Hopewell
      • Contact: Jillian Walsh, MD
  • New York
    • Flushing, New York, United States, 11355
      • Recruiting
      • New York-Presbyterian Queens_The Lang Center for Research & Education
      • Contact: Sheng Kuo, MD
    • Valhalla, New York, United States, 10595
      • Recruiting
      • Ambulatory Care Pavilion Westchester Medical Center
      • Contact: Romeo Mateo, MD
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Recruiting
      • Surgical Specialists of Charlotte
      • Contact: Jason Burgess, MD
    • Durham, North Carolina, United States, 27704
      • Recruiting
      • Duke Regional Hospital
      • Contact: Tristen Chun, MD
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist
      • Contact: Justin Hurie, MD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Recruiting
      • Temple University
      • Contact: Kenneth Chavin, MD
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Recruiting
      • University of Tennessee Medical Center
      • Contact: Oscar Grandas, MD
  • Texas
    • Austin, Texas, United States, 78701
      • Recruiting
      • Dell Seton Medical Center at the University of Texas at Austin
      • Contact: Pedro Teixeira, MD
    • Lubbock, Texas, United States, 79407
      • Recruiting
      • Dr. Ruben Villa__Nephrology
      • Contact: Ruben Villa, MD; Email: villaruben@att.net
      • Contact: Natalie Armendariz; Phone Number: 806-368-8782; Email: narmendariz@drvillalubbock.com
    • Lubbock, Texas, United States, 79410
      • Recruiting
      • Cataract & Surgery Center Lubbock
      • Contact: Ruben Villa, MD
    • San Antonio, Texas, United States, 78221
      • Recruiting
      • San Antonio Vascular and Endovascular Clinic PLLC
      • Contact: Lyssa Ochoa, MD; Email: lochoa@thesaveclinic.com
      • Contact: Carl Negley; Phone Number: 210-259-5836; Email: carl@mdvo.co
    • San Antonio, Texas, United States, 78221
      • Recruiting
      • The San Antonio Vascular and Endovascular Clinic
      • Contact: Lyssa Ochoa, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Female patients with ESRD, currently receiving hemodialysis via dialysis catheter and who are candidates for the creation of an AVF (see Inclusion Criterion #4 below) or implantation of an ATEV for HD access.
2. Patients who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least 12 months after SA creation.
3. Patients aged ≥ 18 years at Screening.

4. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight, curved, or looped ATEV in either the forearm or upper arm.

   NOTE: Suitable anatomy will be determined by both physical examination and ultrasound imaging or vessel imaging modality in addition to consideration of all vascular sites available, prior access failure, future access sites and possibilities to preserve patients' future alternate accesses. Vessel mapping is the preferred method to assess the vascular anatomy, and will evaluate the following attributes during Screening:

   • Vein diameter
   • Arterial diameter
   • Presence of arterial calcification
   • Depth of the intended fistula conduit from the surface of the skin
   • Central vein patency
   • Previous vascular access location The ultimate decision of anatomic suitability belongs to the surgeon and/or the investigator.
5. Hemoglobin ≥ 7 g/dL and platelet count ≥ 100,000 /mm3

6. Patients must either:

   1. Be of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile (i.e., total hysterectomy or tubal ligation, or complete bilateral oophorectomy) at least 1 month prior to Screening.
   2. Or, if of childbearing potential:

   Must have a negative serum pregnancy test at Screening, and

   Must agree to use at least one form of the following birth control methods for the duration of the study:

   i. Established use of oral, injectable or implanted hormonal methods of contraception.

   ii. Placement of an intrauterine device or intrauterine system at least 5 days prior to Screening.

   iii. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.

7. Patient or their legal representative can communicate effectively with investigative staff, is competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.
8. Life expectancy of at least 1 year confirmed by Charlson Comorbidity Index ≤ 9.

Exclusion Criteria:

1. Male sex at birth.
2. Planned AVF creation by means other than suture or vascular anastomotic clips (e.g., endovascular surgery or other anastomotic creation devices). Venous outflow from study access cannot be located more distally than the venous outflow of any previous failed access in that extremity.
3. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.
4. Pregnancy, or women intending to become pregnant during the course of the trial.
5. Treatment with any investigational drug or device within 60 days or 5 half-lives after taking the last dose (whichever is longer) prior to study entry (Day 1) or ongoing participation in a clinical trial of an investigational product.

6. Documented hyper-coagulable state, as defined as either:

   1. Documented hyper-coagulable state, as defined as either: A biochemical diagnosis (e.g., Factor V Leiden, Protein C deficiency, etc.) - OR -
   2. A clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g., deep vein thrombosis (DVT), pulmonary embolism (PE), etc.) within the previous 5 years.
7. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g., von Willebrand's disease, etc.).
8. Cancer actively being treated with a cytotoxic agent.
9. Planned or anticipated renal transplant within 6 months after randomization.
10. Any other condition that in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA.
11. Previous exposure to ATEV.
12. Any of the following within 8 weeks prior to screening: acute coronary syndrome, stroke or congestive heart failure NYHA Stage IV
13. Employees of Humacyte and employees or relatives of an investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AVF treatment arm; AVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm	Other: AVF; AVF creation procedure
Experimental: ATEV treatment arm; ATEV will be implanted as an arterio-venous (AV) access into the forearm or upper arm	Biological: Acellular Tissue Engineered Vessel (ATEV); ATEV implantation; Other Names: Human Acellular Vessel (HAV)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of catheter-free days since randomization to Month 12.	To determine the number of days free from indwelling catheter (catheter-free days) since randomization to 365 days (Month 12), or until SA abandonment, whichever occurs first.	12 months
The rate of infections related to any HD access.	To determine the rate of infections, related to any HD access over the period from SA creation (Day 1) until 12 months (365 days) after SA placement, without regard to SA abandonment.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of catheter-free days since randomization to Month 6.	To determine the number of days free from indwelling catheter (catheter-free days) from randomization to 183 days (Month 6), or until SA abandonment, whichever occurs first.	6 months
The number of days of the study access (SA) functional patency	To determine the number of days of Duration of functional patency of the SA over 12 months from randomization.	12 months
The rate of the study access (SA) secondary patency	To determine the rate of the SA secondary patency at 6 and 12 months from randomization.	6 - 12 months
The number of days from the study access (SA) maturation to abandonment	To determine the number of days from the study access (SA) maturation to abandonment.	12 months
The rate of complications related to any HD access after the study access (SA) creation.	To determine the rate of complications related to any HD access during the 12 months after SA creation, without regard to SA abandonment. For the purposes of this endpoint, HD access refers to any surgically created access or device to provide a route for HD after randomization (e.g., SA, new AVF or AVG, or catheter).	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of HD access-related interventions	Incidence rate of HD access-related interventions over the period from randomization until SA abandonment, or a defined timepoint after randomization (e.g., 12 months).	12 months
The number of days from randomization to first day of functional dialysis	To determine the number of days from randomization to the first day of functional dialysis using the SA.	12 months
Incidence rate of Study Access (SA) abandonment	To determine the incidence rate of SA abandonment.	12 months
Health-related quality of life (HRQoL) of patients (a scale from 0 to 45, with higher scores meaning best outcome)	Health-related quality of life (HRQoL) of patients using the PROMIS-10 Questionnaire, a scale from 0 to 45, where the higher scores mean the best outcome.	12 months
Vascular Access Questionnaire (VAQ) score (range 0-68 with higher scores mean worst outcome).	Vascular Access Questionnaire (VAQ) Questionnaire. The Vascular Access Questionnaire (VAQ) is a patient reported outcome instrument containing 17 items pertaining to the impact of 17 access-related problems. Responses to the questionnaire are summed to produce a total VAQ score (range from 0-68) with higher values indicating more negative views of vascular access.	12 months
The incidence rate of aneurysm or pseudoaneurysm	To determine the incidence rate of clinically significant aneurysm or pseudoaneurysm of the SA over the period from SA creation to 12 months.	12 months
The incidence rate of adverse events (AEs)	To determine the incidence rate of adverse events (AEs) from SA creation to 12 months.	12 months

Collaborators and Investigators

• Sponsor: Humacyte, Inc.
• Collaborators: IQVIA Biotech

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: June 8, 2023
• First Posted (Actual): June 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: hemodialysis (HD); dialysis catheter
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: CLN-PRO-V012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No