Actively Recruiting
To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
Led by Humacyte, Inc. · Updated on 2025-03-18
150
Participants Needed
32
Research Sites
212 weeks
Total Duration
On this page
Sponsors
H
Humacyte, Inc.
Lead Sponsor
I
IQVIA Biotech
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with ESRD currently on hemodialysis via dialysis catheter and candidates for AVF creation or ATEV implantation
- Plan to undergo hemodialysis at a participating dialysis unit for at least 12 months after access creation
- Age 18 years or older at screening
- Suitable anatomy for forearm or upper arm AVF creation or ATEV implantation as determined by physical exam and vessel imaging
- Hemoglobin level of at least 7 g/dL and platelet count of at least 100,000/mm3
- Either non-childbearing potential (post-menopausal or surgically sterile) or if of childbearing potential, negative pregnancy test and agreement to use approved birth control methods
- Ability to communicate effectively, provide informed consent, and comply with study procedures
- Life expectancy of at least 1 year with Charlson Comorbidity Index of 9 or less
You will not qualify if you...
- Male sex at birth
- Planned AVF creation using methods other than suture or vascular anastomotic clips
- Known serious allergy or intolerance to aspirin or alternative antiplatelet therapy
- Pregnancy or intention to become pregnant during the study
- Treatment with investigational drug or device within 60 days or 5 half-lives prior to study entry or ongoing investigational product participation
- Documented hyper-coagulable state by biochemical diagnosis or clinical history of thrombophilia with multiple thrombotic events in last 5 years
- Documented bleeding disorders within last 5 years
- Active cancer treatment with cytotoxic agents
- Planned or anticipated renal transplant within 6 months after randomization
- Any condition that would prevent adequate evaluation of safety and efficacy
- Previous exposure to ATEV
- Acute coronary syndrome, stroke, or congestive heart failure NYHA Stage IV within 8 weeks prior to screening
- Employees of Humacyte or relatives of investigators
AI-Screening
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Trial Site Locations
Total: 32 locations
1
Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona, United States, 85260
Actively Recruiting
2
El Centro Regional Medical Center
El Centro, California, United States, 92243
Actively Recruiting
3
Jacob's Medical Center at UC San Diego Health
La Jolla, California, United States, 92037
Actively Recruiting
4
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Actively Recruiting
5
Yale New Haven Hospital
New Haven, Connecticut, United States, 06519
Actively Recruiting
6
Access Research Institute
Brooksville, Florida, United States, 34613
Actively Recruiting
7
University of FL Health Heart and Vascular Hospital
Gainesville, Florida, United States, 32608
Actively Recruiting
8
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
9
American Access Care of Miami, LLC
Miami, Florida, United States, 33156
Actively Recruiting
10
USF Health South Tampa
Tampa, Florida, United States, 33606
Actively Recruiting
11
Georgia Nephrology
Atlanta, Georgia, United States, 30046
Actively Recruiting
12
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Actively Recruiting
13
IU Health Bloomington Hospital
Bloomington, Indiana, United States, 47408
Actively Recruiting
14
John Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
15
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
16
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
17
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
18
Rutgers University_Medical
Newark, New Jersey, United States, 07103
Actively Recruiting
19
St.Joseph's University Medical Center
Paterson, New Jersey, United States, 07503
Actively Recruiting
20
Capital Health Medical Center- Hopewell
Pennington, New Jersey, United States, 08534
Actively Recruiting
21
New York-Presbyterian Queens_The Lang Center for Research & Education
Flushing, New York, United States, 11355
Actively Recruiting
22
Ambulatory Care Pavilion Westchester Medical Center
Valhalla, New York, United States, 10595
Actively Recruiting
23
Surgical Specialists of Charlotte
Charlotte, North Carolina, United States, 28207
Actively Recruiting
24
Duke Regional Hospital
Durham, North Carolina, United States, 27704
Actively Recruiting
25
Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
26
Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
27
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
28
Dell Seton Medical Center at The University of Texas at Austin
Austin, Texas, United States, 78701
Actively Recruiting
29
Dr. Ruben Villa__Nephrology
Lubbock, Texas, United States, 79407
Actively Recruiting
30
Cataract & Surgery Center Lubbock
Lubbock, Texas, United States, 79410
Actively Recruiting
31
San Antonio Vascular and Endovascular Clinic PLLC
San Antonio, Texas, United States, 78221
Actively Recruiting
32
The San Antonio Vascular and Endovascular Clinic
San Antonio, Texas, United States, 78221
Actively Recruiting
Research Team
J
Jordanna Foster
CONTACT
E
Elizabeth Taylor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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