To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
Active, not recruiting · Phase 3 · NCT05908084
Conditions: End Stage Renal Disease (ESRD)
At a glance
- Research payments reported, 2025
- $712,156
- U.S. investigators named
- 28
- Sites paid
- 28
- Planned or actual enrollment
- 121
About the trial
- Sponsor
- Humacyte, Inc. (with IQVIA Biotech)
- Tested
- Acellular Tissue Engineered Vessel (ATEV) (biological), AVF (other)
- Dates
- Started 2023-09-07; completion 2028-06
- Results posted
- Not yet
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).
From ClinicalTrials.gov, last updated 2026-06-26. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Humacyte Global, Inc. reported $712,156 in research payments for this study in 2025 (172 payments).
Products named: Symvess
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Hasan Aldailami, M.D. Vascular Surgery · Scottsdale, AZ
- Manuel Garcia-toca, MD Vascular Surgery · Stanford, CA
- Mahmoud Malas, M.D. Vascular Surgery · La Jolla, CA
- Ernest E. Moore, MD General Surgery · Denver, CO
- Cassius Iyad N. Ochoa Chaar, M.D., M.S. Vascular Surgery · New Haven, CT
- Young M. Erben, M.D. Vascular Surgery · Jacksonville, FL
- Jose A. Ramirez, M.D. Vascular Surgery · Miami, FL
- Samir K. Shah, MD Vascular Surgery · Gainesville, FL
- Aurelia F. Thibonnier, MD Vascular Surgery · Wesley Chapel, FL
- James A. Tumlin, M.D. Nephrology (Kidney) · Lawrenceville, GA
- Mohamad A. Hussain, MD, PHD Vascular Surgery · Boston, MA
- Jeffrey J. Siracuse, M.D. Vascular Surgery · Boston, MA
- Ying Wei Lum, M.D. Vascular Surgery · Baltimore, MD
- Jason S. Burgess, MD General Surgery · Charlotte, NC
- Justin Hurie, MD Vascular Surgery · Winston Salem, NC
- David A. Peterson, MD Vascular Surgery · Angier, NC
- Michael A. Curi, MD Vascular Surgery · Newark, NJ
- Jillian P. Walsh, MD. Vascular Surgery · Pennington, NJ
- Sheng F. Kuo, M.D. Nephrology (Kidney) · Bronx, NY
- Romeo Mateo, MD Vascular Surgery · Hawthorne, NY
- Kenneth D. Chavin, MD, PHD General Surgery · Philadelphia, PA
- Eric T. Choi, MD Vascular Surgery · Philadelphia, PA
- Tristen Chun, M.D. General Surgery · Providence, RI
- Oscar H. Grandas, MD Vascular Surgery · Knoxville, TN
- Karthik Ramani, MD Nephrology (Kidney) · Brentwood, TN
- Lyssa N. Ochoa, MD Vascular Surgery · San Antonio, TX
- Pedro G. Teixeira, MD Vascular Surgery · Austin, TX
- Ruben D. Villa, M.D. Nephrology (Kidney) · Lubbock, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Nephronet Cro LLC $110,235
- Brigham and Women's Hospital, MA $99,204
- Yale University $81,254
- University of Michigan Health System, MI $49,462
- Boston Medical Center, MA $46,288
- Duke University $40,447
- Johns Hopkins University $30,325
- University of South Florida $26,750
- Denver Health & Hospital Authority, CO $25,392
- Mayo Clinic Jacksonville $23,925
- Wake Forest University Health Sciences $23,118
- Ascension Seton Medical Center Austin, TX $15,814
- St Joseph's University Medical Center Inc, NJ $14,221
- Honor Health John C. Lincoln Medical Center, AZ $13,900
- Capital Health Medical Center - Hopewell, NJ $12,651
- Indiana University Health, IN $11,219
- University of Florida $10,841
- Surgical Specialists of Charlotte PA $9,686
- Ruben Villa $8,620
- Temple University of the Commonwealth System of Higher Education $8,459
- Emory University Hospital, GA $7,510
- American Access Care of Miami, LLC $7,272
- New York Medical College $7,270
- University Health System, Inc, TN $7,007
- San Antonio Vascular and Endovascular Clinic PLLC $6,663
- New York-Presbyterian/queens, NY $5,617
- Uci Health-Orange, CA $5,353
- Rutgers, the State University $3,653
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.