A Phase 3 interventional study of Acellular Tissue Engineered Vessel (ATEV) and AVF in End Stage Renal Disease (ESRD), sponsored by Humacyte, Inc.. Active, not recruiting at 32 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Humacyte, Inc. · Phase 3, Interventional, and Treatment
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).
This is a prospective, multicenter, randomized, two-arm, comparative Phase 3 study of female patients with ESRD, who are receiving clinically successful hemodialysis (HD) via a central venous dialysis catheter (DC).
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.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's enrollment of 121 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →Humacyte, Inc. is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Patients must either:
Must have a negative serum pregnancy test at Screening, and
Must agree to use at least one form of the following 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.
Exclusion Criteria:
Documented hyper-coagulable state, as defined as either:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ATEV will be implanted as an arterio-venous (AV) access into the forearm or upper arm
Biological: Acellular Tissue Engineered Vessel (ATEV)
AVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm
Other: AVF
ATEV implantation
Also known as: Human Acellular Vessel (HAV)
AVF creation procedure
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.
Time frame: 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.
Time frame: 12 months
The number of catheter-free days since randomization to Month 6.
To determine the number of days free from indwelling catheter (catheter-free days) from randomization to 183 days (Month 6), or until SA abandonment, whichever occurs first.
Time frame: 6 months
The number of days of the study access (SA) functional patency
To determine the number of days of Duration of functional patency of the SA over 12 months from randomization.
Time frame: 12 months
The rate of the study access (SA) secondary patency
To determine the rate of the SA secondary patency at 6 and 12 months from randomization.
Time frame: 6 - 12 months
The number of days from the study access (SA) maturation to abandonment
To determine the number of days from the study access (SA) maturation to abandonment.
Time frame: 12 months
The rate of complications related to any HD access after the study access (SA) creation.
To determine the rate of complications related to any HD access during the 12 months after SA creation, without regard to SA abandonment. For the purposes of this endpoint, HD access refers to any surgically created access or device to provide a route for HD after randomization (e.g., SA, new AVF or AVG, or catheter).
Time frame: 12 months
Incidence rate of HD access-related interventions
Incidence rate of HD access-related interventions over the period from randomization until SA abandonment, or a defined timepoint after randomization (e.g., 12 months).
Time frame: 12 months
The number of days from randomization to first day of functional dialysis
To determine the number of days from randomization to the first day of functional dialysis using the SA.
Time frame: 12 months
Incidence rate of Study Access (SA) abandonment
To determine the incidence rate of SA abandonment.
Time frame: 12 months
Health-related quality of life (HRQoL) of patients (a scale from 0 to 45, with higher scores meaning best outcome)
Health-related quality of life (HRQoL) of patients using the PROMIS-10 Questionnaire, a scale from 0 to 45, where the higher scores mean the best outcome.
Time frame: 12 months
Vascular Access Questionnaire (VAQ) score (range 0-68 with higher scores mean worst outcome).
Vascular Access Questionnaire (VAQ) Questionnaire. The Vascular Access Questionnaire (VAQ) is a patient reported outcome instrument containing 17 items pertaining to the impact of 17 access-related problems. Responses to the questionnaire are summed to produce a total VAQ score (range from 0-68) with higher values indicating more negative views of vascular access.
Time frame: 12 months
The incidence rate of aneurysm or pseudoaneurysm
To determine the incidence rate of clinically significant aneurysm or pseudoaneurysm of the SA over the period from SA creation to 12 months.
Time frame: 12 months
The incidence rate of adverse events (AEs)
To determine the incidence rate of adverse events (AEs) from SA creation to 12 months.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Jun 2027, 45 months after the start.
Of 42 industry-sponsored phase 3 interventional studies under Kidney Failure, Chronic, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 40. This study's planned 45 months is above that.
Counting every sponsor, half of 66 studies reached it within 32 months; a quarter within 21 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Human acellular vessel extra-cellular matrix