RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2023-09-07
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05908084

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 3. Patients aged ≥ 18 years at Screening.
  4. 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.
  5. * Vein diameter
  6. * Arterial diameter
  7. * Presence of arterial calcification
  8. * Depth of the intended fistula conduit from the surface of the skin
  9. * Central vein patency
  10. * Previous vascular access location The ultimate decision of anatomic suitability belongs to the surgeon and/or the investigator.
  11. 5. Hemoglobin ≥ 7 g/dL and platelet count ≥ 100,000 /mm3
  12. 6. Patients must either:
  13. 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.
  14. 2. Or, if of childbearing potential:
  15. 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.
  16. 8. Life expectancy of at least 1 year confirmed by Charlson Comorbidity Index ≤ 9.
  1. 1. Male sex at birth.
  2. 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. 3. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.
  4. 4. Pregnancy, or women intending to become pregnant during the course of the trial.
  5. 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. 6. Documented hyper-coagulable state, as defined as either:
  7. 1. Documented hyper-coagulable state, as defined as either: A biochemical diagnosis (e.g., Factor V Leiden, Protein C deficiency, etc.) - OR -
  8. 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.
  9. 7. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g., von Willebrand's disease, etc.).
  10. 8. Cancer actively being treated with a cytotoxic agent.
  11. 9. Planned or anticipated renal transplant within 6 months after randomization.
  12. 10. Any other condition that in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA.
  13. 11. Previous exposure to ATEV.
  14. 12. Any of the following within 8 weeks prior to screening: acute coronary syndrome, stroke or congestive heart failure NYHA Stage IV
  15. 13. Employees of Humacyte and employees or relatives of an investigator.

Contacts and Locations

Study Contact

Jordanna Foster
CONTACT
919.313.9633
jfoster@humacyte.com
Elizabeth Taylor
CONTACT
919.313.9633
etaylor@humacyte.com

Study Locations (Sites)

Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260
United States
El Centro Regional Medical Center
El Centro, California, 92243
United States
Jacob's Medical Center at UC San Diego Health
La Jolla, California, 92037
United States
Denver Health and Hospital Authority
Denver, Colorado, 80204
United States
Yale New Haven Hospital
New Haven, Connecticut, 06519
United States
Access Research Institute
Brooksville, Florida, 34613
United States
University of FL Health Heart and Vascular Hospital
Gainesville, Florida, 32608
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
American Access Care of Miami, LLC
Miami, Florida, 33156
United States
USF Health South Tampa
Tampa, Florida, 33606
United States
Georgia Nephrology
Atlanta, Georgia, 30046
United States
Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
IU Health Bloomington Hospital
Bloomington, Indiana, 47408
United States
John Hopkins University School of Medicine
Baltimore, Maryland, 21287
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Rutgers University_Medical
Newark, New Jersey, 07103
United States
St.Joseph's University Medical Center
Paterson, New Jersey, 07503
United States
Capital Health Medical Center- Hopewell
Pennington, New Jersey, 08534
United States
New York-Presbyterian Queens_The Lang Center for Research & Education
Flushing, New York, 11355
United States
Ambulatory Care Pavilion Westchester Medical Center
Valhalla, New York, 10595
United States
Surgical Specialists of Charlotte
Charlotte, North Carolina, 28207
United States
Duke Regional Hospital
Durham, North Carolina, 27704
United States
Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
Temple University
Philadelphia, Pennsylvania, 19140
United States
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
United States
Dell Seton Medical Center at The University of Texas at Austin
Austin, Texas, 78701
United States
Dr. Ruben Villa__Nephrology
Lubbock, Texas, 79407
United States
Cataract & Surgery Center Lubbock
Lubbock, Texas, 79410
United States
San Antonio Vascular and Endovascular Clinic PLLC
San Antonio, Texas, 78221
United States
The San Antonio Vascular and Endovascular Clinic
San Antonio, Texas, 78221
United States

Collaborators and Investigators

Sponsor: Humacyte, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-07
Study Completion Date2027-10

Study Record Updates

Study Start Date2023-09-07
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • hemodialysis (HD)
  • dialysis catheter

Additional Relevant MeSH Terms

  • End Stage Renal Disease (ESRD)