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

NCT05908084 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: CLN-PRO-V012
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 32

Brief Summary

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

End Stage Renal Disease (ESRD)

Keywords

hemodialysis (HD); dialysis catheter

Outcome Measures

Primary Outcomes (2)

• The number of catheter-free days since randomization to Month 12.

  To determine the number of days free from indwelling catheter (catheter-free days) since randomization to 365 days (Month 12), or until SA abandonment, whichever occurs first.

  12 months

• The rate of infections related to any HD access.

  To determine the rate of infections, related to any HD access over the period from SA creation (Day 1) until 12 months (365 days) after SA placement, without regard to SA abandonment.

  12 months

Secondary Outcomes (5)

• The number of catheter-free days since randomization to Month 6.

  6 months

• The number of days of the study access (SA) functional patency

  12 months

• The rate of the study access (SA) secondary patency

  6 - 12 months

• The number of days from the study access (SA) maturation to abandonment

  12 months

• The rate of complications related to any HD access after the study access (SA) creation.

  12 months

Other Outcomes (7)

• Incidence rate of HD access-related interventions

  12 months

• The number of days from randomization to first day of functional dialysis

  12 months

• Incidence rate of Study Access (SA) abandonment

  12 months

Study Arms (2)

ATEV treatment arm

EXPERIMENTAL

ATEV will be implanted as an arterio-venous (AV) access into the forearm or upper arm

Biological: Acellular Tissue Engineered Vessel (ATEV)

AVF treatment arm

ACTIVE COMPARATOR

AVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm

Other: AVF

Interventions

Acellular Tissue Engineered Vessel (ATEV) BIOLOGICAL

ATEV implantation

Also known as: Human Acellular Vessel (HAV)

ATEV treatment arm

AVF OTHER

AVF creation procedure

AVF treatment arm

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least 12 months after SA creation.
• Patients aged ≥ 18 years at Screening.
• 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.
• Hemoglobin ≥ 7 g/dL and platelet count ≥ 100,000 /mm3
• Patients must either:
• 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.
• Or, if of childbearing potential:
• Must have a negative serum pregnancy test at Screening, and

You may not qualify if:

• Male sex at birth.
• 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.
• Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.
• Pregnancy, or women intending to become pregnant during the course of the trial.
• 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.
• Documented hyper-coagulable state, as defined as either:
• Documented hyper-coagulable state, as defined as either: A biochemical diagnosis (e.g., Factor V Leiden, Protein C deficiency, etc.) - OR -
• 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.
• Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g., von Willebrand's disease, etc.).
• Cancer actively being treated with a cytotoxic agent.
• Planned or anticipated renal transplant within 6 months after randomization.
• Any other condition that in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA.
• Previous exposure to ATEV.
• Any of the following within 8 weeks prior to screening: acute coronary syndrome, stroke or congestive heart failure NYHA Stage IV
• Employees of Humacyte and employees or relatives of an investigator.

Sponsors & Collaborators

• Humacyte, Inc.: lead
• IQVIA Biotech: collaborator

Study Sites (32)

Honor Health Scottsdale Shea Medical Center

Scottsdale, Arizona, 85260, United States

RECRUITING

El Centro Regional Medical Center

El Centro, California, 92243, United States

RECRUITING

Jacob's Medical Center at UC San Diego Health

La Jolla, California, 92037, United States

RECRUITING

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

RECRUITING

Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

RECRUITING

Access Research Institute

Brooksville, Florida, 34613, United States

RECRUITING

University of FL Health Heart and Vascular Hospital

Gainesville, Florida, 32608, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

American Access Care of Miami, LLC

Miami, Florida, 33156, United States

RECRUITING

USF Health South Tampa

Tampa, Florida, 33606, United States

RECRUITING

Georgia Nephrology

Atlanta, Georgia, 30046, United States

RECRUITING

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

IU Health Bloomington Hospital

Bloomington, Indiana, 47408, United States

RECRUITING

John Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Rutgers University_Medical

Newark, New Jersey, 07103, United States

RECRUITING

St.Joseph's University Medical Center

Paterson, New Jersey, 07503, United States

RECRUITING

Capital Health Medical Center- Hopewell

Pennington, New Jersey, 08534, United States

RECRUITING

New York-Presbyterian Queens_The Lang Center for Research & Education

Flushing, New York, 11355, United States

RECRUITING

Ambulatory Care Pavilion Westchester Medical Center

Valhalla, New York, 10595, United States

RECRUITING

Surgical Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

RECRUITING

Duke Regional Hospital

Durham, North Carolina, 27704, United States

RECRUITING

Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States

RECRUITING

Dell Seton Medical Center at The University of Texas at Austin

Austin, Texas, 78701, United States

RECRUITING

Dr. Ruben Villa__Nephrology

Lubbock, Texas, 79407, United States

RECRUITING

Cataract & Surgery Center Lubbock

Lubbock, Texas, 79410, United States

RECRUITING

San Antonio Vascular and Endovascular Clinic PLLC

San Antonio, Texas, 78221, United States

RECRUITING

The San Antonio Vascular and Endovascular Clinic

San Antonio, Texas, 78221, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jordanna Foster

CONTACT

919.313.9633; jfoster@humacyte.com

Elizabeth Taylor

CONTACT

919.313.9633; etaylor@humacyte.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study team at each site, including the surgeon performing the AVF creation or ATEV implantation, the operating room staff, the dispensing pharmacist, and the Principal Investigator will be unblinded to treatment allocation. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: Randomized 1:1 to either the ATEV or the AVF treatment arm.

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: June 18, 2023
• Study Start: September 7, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (32)