End Stage Renal Disease (ESRD)Phase 3NCT05908084
To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
A Phase 3 study testing Acellular Tissue Engineered Vessel (ATEV) and AVF in people with End Stage Renal Disease (ESRD), run by Humacyte, Inc. at 32 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- End Stage Renal Disease (ESRD)
- What is being tested?
- Acellular Tissue Engineered Vessel (ATEV) and AVF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 32 sitesUnited States
- Study dates
- 7 Sep 2023to Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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
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- 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
- Must agree to use at least one form of the following birth control methods for the duration of the study:
- Established use of oral, injectable or implanted hormonal methods of contraception.
- Placement of an intrauterine device or intrauterine system at least 5 days prior to Screening.
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.
- 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.
- Life expectancy of at least 1 year confirmed by Charlson Comorbidity Index ≤ 9.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
University of Michigan
Ann Arbor, Michigan, 48109
Georgia Nephrology
Atlanta, Georgia, 30046
Grady Memorial Hospital
Atlanta, Georgia, 30303
Dell Seton Medical Center at The University of Texas at Austin
Austin, Texas, 78701
John Hopkins University School of Medicine
Baltimore, Maryland, 21287
IU Health Bloomington Hospital
Bloomington, Indiana, 47408
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boston Medical Center
Boston, Massachusetts, 02118
Access Research Institute
Brooksville, Florida, 34613
Surgical Specialists of Charlotte
Charlotte, North Carolina, 28207
Denver Health and Hospital Authority
Denver, Colorado, 80204
Duke Regional Hospital
Durham, North Carolina, 27704
El Centro Regional Medical Center
El Centro, California, 92243
New York-Presbyterian Queens_The Lang Center for Research & Education
Flushing, New York, 11355
University of FL Health Heart and Vascular Hospital
Gainesville, Florida, 32608
Mayo Clinic Florida
Jacksonville, Florida, 32224
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Jacob's Medical Center at UC San Diego Health
La Jolla, California, 92037
Dr. Ruben Villa__Nephrology
Lubbock, Texas, 79407
Cataract & Surgery Center Lubbock
Lubbock, Texas, 79410
American Access Care of Miami, LLC
Miami, Florida, 33156
Yale New Haven Hospital
New Haven, Connecticut, 06519
Rutgers University_Medical
Newark, New Jersey, 07103
St.Joseph's University Medical Center
Paterson, New Jersey, 07503
Capital Health Medical Center- Hopewell
Pennington, New Jersey, 08534
Temple University
Philadelphia, Pennsylvania, 19140
San Antonio Vascular and Endovascular Clinic PLLC
San Antonio, Texas, 78221
The San Antonio Vascular and Endovascular Clinic
San Antonio, Texas, 78221
Honor Health Scottsdale Shea Medical Center
Scottsdale, Arizona, 85260
USF Health South Tampa
Tampa, Florida, 33606
Ambulatory Care Pavilion Westchester Medical Center
Valhalla, New York, 10595
Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
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
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).
Read the detailed description
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.
- Conditions
- End Stage Renal Disease (ESRD)
- Being tested
- Acellular Tissue Engineered Vessel (ATEV), AVF
- Keywords
- hemodialysis (HD), dialysis catheter
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Tissue Engineered Vessel (ATEV)Biological
Also called Human Acellular Vessel (HAV)
ATEV implantation
AVFOther
AVF creation procedure
| Study group | Role | What they receive |
|---|---|---|
| ATEV treatment arm | Experimental | ATEV will be implanted as an arterio-venous (AV) access into the forearm or upper arm Receives: 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 Receives: Other: AVF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start7 Sep 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized 1:1 to either the ATEV or the AVF treatment arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Biotech
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05908084
- Sponsor's protocol ID
- CLN-PRO-V012
- Status last verified
- Jun 2026
- First submitted
- 28 Apr 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quinn RR, Oliver MJ, Wald R, Hiremath S, Pauly RP, Miller L, Barrett B, Nesrallah G, Gallagher M, Kotwal S, Gray NA, Hassan HC, Talaulikar GS, Thorpe K, Graham J, Clarke A, Bian J, MacRae J, Santana M, Bohm C, Mamdani M, Nagpal S, Yilmaz S, Moist L, Ravani P. Comparing Catheters with Fistulas in Older Patients Starting Hemodialysis: A Pilot Randomized Controlled Trial. J Am Soc Nephrol. 2026 Jun 22. doi: 10.1681/ASN.0000001160. Online ahead of print.
PubMed 42319856
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05908084
- Acronym / sponsor ID
- CLN-PRO-V012
- Conditions
- End Stage Renal Disease (ESRD)
- Keywords
- hemodialysis (HD), dialysis catheter
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Biotech
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized 1:1 to either the ATEV or the AVF treatment arm.
| Arm | Type | Receives |
|---|---|---|
| ATEV treatment arm | Experimental | Biological: Acellular Tissue Engineered Vessel (ATEV)ATEV will be implanted as an arterio-venous (AV) access into the forearm or upper arm |
| AVF treatment arm | Active comparator | Other: AVFAVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
- 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:
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acellular Tissue Engineered Vessel (ATEV)Also: Human Acellular Vessel (HAV)ATEV implantation | Biological | ATEV treatment arm |
| AVFAVF creation procedure | Other | AVF treatment arm |
Primary outcome
The number of catheter-free days since randomization to Month 12.
Time frame: 12 months
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.
The rate of infections related to any HD access.
Time frame: 12 months
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.
5 secondary outcomes
The number of catheter-free days since randomization to Month 6.
Time frame: 6 months
The number of days of the study access (SA) functional patency
Time frame: 12 months
The rate of the study access (SA) secondary patency
Time frame: 6 - 12 months
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.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Derived from this study: PubMed 42319856Quinn RR, Oliver MJ, Wald R, Hiremath S, Pauly RP, Miller L, Barrett B, Nesrallah G, Gallagher M, Kotwal S, Gray NA, Hassan HC, Talaulikar GS, Thorpe K, Graham J, Clarke A, Bian J, MacRae J, Santana M, Bohm C, Mamdani M, Nagpal S, Yilmaz S, Moist L, Ravani P. Comparing Catheters with Fistulas in Older Patients Starting Hemodialysis: A Pilot Randomized Controlled Trial. J Am Soc Nephrol. 2026 Jun 22. doi: 10.1681/ASN.0000001160. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acellular Tissue Engineered Vessel (ATEV) and AVF in people with End Stage Renal Disease (ESRD), run by Humacyte, Inc. at 32 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of catheter-free days since randomization to Month 12. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05908084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.