🏛️ Verified NIH Record • Updated 2026-06-23

To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis (NCT05908084)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Humacyte, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Honor Health Scottsdale Shea Medical Center — Scottsdale, Arizona

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (32 Sites)

Showing the first 25 of 32 sites.

  • Honor Health Scottsdale Shea Medical Center — Scottsdale, Arizona
  • El Centro Regional Medical Center — El Centro, California
  • Jacob's Medical Center at UC San Diego Health — La Jolla, California
  • Denver Health and Hospital Authority — Denver, Colorado
  • Yale New Haven Hospital — New Haven, Connecticut
  • Access Research Institute — Brooksville, Florida
  • University of FL Health Heart and Vascular Hospital — Gainesville, Florida
  • Mayo Clinic Florida — Jacksonville, Florida
  • American Access Care of Miami, LLC — Miami, Florida
  • USF Health South Tampa — Tampa, Florida
  • Georgia Nephrology — Atlanta, Georgia
  • Grady Memorial Hospital — Atlanta, Georgia
  • IU Health Bloomington Hospital — Bloomington, Indiana
  • John Hopkins University School of Medicine — Baltimore, Maryland
  • Brigham and Women's Hospital — Boston, Massachusetts
  • Boston Medical Center — Boston, Massachusetts
  • University of Michigan — Ann Arbor, Michigan
  • Rutgers University_Medical — Newark, New Jersey
  • St.Joseph's University Medical Center — Paterson, New Jersey
  • Capital Health Medical Center- Hopewell — Pennington, New Jersey
  • New York-Presbyterian Queens_The Lang Center for Research & Education — Flushing, New York
  • Ambulatory Care Pavilion Westchester Medical Center — Valhalla, New York
  • Surgical Specialists of Charlotte — Charlotte, North Carolina
  • Duke Regional Hospital — Durham, North Carolina
  • Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗