Home › Trials › NCT05908084

Comparing two methods for hemodialysis access in women with end-stage renal disease

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

Phase 3 Interventional Humacyte, Inc. · NCT05908084

This study is testing whether a new type of blood vessel made from tissue can work better and be safer than the standard method for connecting blood vessels in women with end-stage kidney disease who need hemodialysis.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexFemale
SponsorHumacyte, Inc. Industry-sponsored
Locations32 sites (Scottsdale, Arizona and 31 other locations)
Trial IDNCT05908084 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the efficacy and safety of an Acellular Tissue Engineered Vessel (ATEV) versus an Arterio-Venous Fistula (AVF) in female patients with end-stage renal disease (ESRD) who require hemodialysis. Approximately 150 participants will be randomly assigned to either treatment group and followed for 12 months to assess the number of catheter-free days and the incidence of dialysis access-related infections. Participants will be stratified based on the location of vascular access and the type of AVF creation procedure planned. The study seeks to provide insights into the effectiveness of ATEV compared to the standard AVF approach.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 and older with ESRD currently receiving hemodialysis via a catheter and suitable anatomy for AVF or ATEV creation.

Not a fit: Patients who are not female, those under 18 years old, or those without suitable vascular anatomy for the procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved hemodialysis access options for female patients with ESRD, potentially reducing infection rates and increasing quality of life.

How similar studies have performed: Other studies have shown promise in using tissue-engineered vessels for vascular access, but this specific comparison is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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. 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:

1. Male sex at birth.
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.

Where this trial is running

Scottsdale, Arizona and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions End Stage Renal Diseasehemodialysisdialysis catheter
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.