To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
NCT ID: NCT05908084
Last Updated: 2025-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2023-09-07
2027-10-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Members of the Data Monitoring Committee and the Clinical Evaluation Committee, as well as members of the CRO staff may be unblinded to treatment assignment to perform their functions.
All Sponsor staff, with exception of Chief Medical Officer (CMO) and Head of Biometrics will be unblinded to treatment allocation. Humacyte CMO and Head of Biometrics will be blinded to treatment allocation until the time of the prespecified interim analysis, approximately 12 months after the 80th participant is randomized.
Study Groups
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ATEV treatment arm
ATEV will be implanted as an arterio-venous (AV) access into the forearm or upper arm
Acellular Tissue Engineered Vessel (ATEV)
ATEV implantation
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
AVF
AVF creation procedure
Interventions
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Acellular Tissue Engineered Vessel (ATEV)
ATEV implantation
AVF
AVF creation procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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IQVIA Biotech
INDUSTRY
Humacyte, Inc.
INDUSTRY
Responsible Party
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Locations
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Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona, United States
El Centro Regional Medical Center
El Centro, California, United States
Jacob's Medical Center at UC San Diego Health
La Jolla, California, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
Yale New Haven Hospital
New Haven, Connecticut, United States
Access Research Institute
Brooksville, Florida, United States
University of FL Health Heart and Vascular Hospital
Gainesville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
American Access Care of Miami, LLC
Miami, Florida, United States
USF Health South Tampa
Tampa, Florida, United States
Georgia Nephrology
Atlanta, Georgia, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
IU Health Bloomington Hospital
Bloomington, Indiana, United States
John Hopkins University School of Medicine
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Rutgers University_Medical
Newark, New Jersey, United States
St.Joseph's University Medical Center
Paterson, New Jersey, United States
Capital Health Medical Center- Hopewell
Pennington, New Jersey, United States
New York-Presbyterian Queens_The Lang Center for Research & Education
Flushing, New York, United States
Ambulatory Care Pavilion Westchester Medical Center
Valhalla, New York, United States
Surgical Specialists of Charlotte
Charlotte, North Carolina, United States
Duke Regional Hospital
Durham, North Carolina, United States
Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Dell Seton Medical Center at The University of Texas at Austin
Austin, Texas, United States
Dr. Ruben Villa__Nephrology
Lubbock, Texas, United States
Cataract & Surgery Center Lubbock
Lubbock, Texas, United States
San Antonio Vascular and Endovascular Clinic PLLC
San Antonio, Texas, United States
The San Antonio Vascular and Endovascular Clinic
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Hasan Aldailami, MD
Role: primary
Luis Cajas-Monson, MD
Role: primary
Mahmoud Malas, MD
Role: primary
Ernest Moore, MD
Role: primary
Cassius Chaar, MD
Role: primary
Lyle Breeding, MD
Role: primary
Samir Shah, MD
Role: primary
Young Erben, MD
Role: primary
Jose Ramirez, MD
Role: primary
Aurelia Calero, MD
Role: primary
James Tumlin, MD
Role: primary
Manuel Garcia-Toca, MD
Role: primary
David Peterson, MD
Role: primary
Ying Wei Lum, MD
Role: primary
Mohamad Hussain, MD
Role: primary
Jeffrey Siracuse, MD
Role: primary
Karthik Ramani, MD
Role: primary
Michael Curi, MD
Role: primary
John Danks, MD
Role: primary
Jillian Walsh, MD
Role: primary
Sheng Kuo, MD
Role: primary
Romeo Mateo, MD
Role: primary
Jason Burgess, MD
Role: primary
Tristen Chun, MD
Role: primary
Justin Hurie, MD
Role: primary
Kenneth Chavin, MD
Role: primary
Oscar Grandas, MD
Role: primary
Pedro Teixeira, MD
Role: primary
Ruben Villa, MD
Role: primary
Lyssa Ochoa, MD
Role: primary
Other Identifiers
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CLN-PRO-V012
Identifier Type: -
Identifier Source: org_study_id
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