Renal FailurePhase 3NCT03183245
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
A Phase 3 study testing Human Acellular Vessel (HAV), Arteriovenous fistula (AVF) and Hemodialysis in people with Renal Failure and End Stage Renal Disease, run by Humacyte, Inc. at 31 sites in United States.
Trial summary
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, End Stage Renal Disease, Hemodialysis
- What is being tested?
- Human Acellular Vessel (HAV), Arteriovenous fistula (AVF) and Hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 31 sitesUnited States
- Study dates
- 29 Sep 2017to 19 Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitable for the creation of an AVF or implantation of AVG for HD access.
- Subjects who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 6 months after SA creation.
- Subjects aged at least 18 years at Screening.
- Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight or looped HAV in either the forearm or upper arm.
- Hemoglobin ≥8 g/dL and platelet count ≥100,000 /mm3.
- International Normalized Ratio (INR) ≤ 1.5.
Show all 15Show fewer
- Female subjects must be either:
- Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).
- Or, of childbearing potential, in which case:
- Must have a negative urine or serum pregnancy test at Screening, and ii. 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.
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.
- Subject, or legal representative, able to communicate effectively with investigative staff, 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 2 years.
Who cannot join
- Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL of the following criteria:
- No previous failed AVF.
- Cephalic vein diameter on ultrasound of more than 3.5mm.
- Radial artery diameter on ultrasound of more than 3mm.
- Vein depth of less than 0.5cm from the skin.
- Normal Allen's test indicating that ulnar artery flow to the hand is sufficient.
Show all 37Show fewer
- No calcification in the wall of the distal radial artery.
- Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment.
- No evidence of iatrogenic injury to target artery or vein.
- Uncontrolled diabetes;
- HbA1c >10% (at Screening).
- History or evidence of severe peripheral arterial disease in the extremity selected for implant.
- Known or suspected central vein stenosis or obstruction on the side of planned SA creation, unless corrected prior to randomization.
- Planned AVF creation that requires more than one stage to complete. (e.g. basilic vein transposition AVF performed in 2 stages).
- Planned AVF creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices).
- Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product.
- Cancer that is actively being treated with a cytotoxic agent.
- Documented hyper-coagulable state.
- Bleeding diathesis.
- Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
- Low dose glucocorticoid therapy (e.g. 5-10mg prednisone [Deltason]) is acceptable.
- High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
- Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
- The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
- tacrolimus or FK506 [Prograf]
- mycophenolate mofetil [Cellcept],
- cyclosporine [Sandimmune or Gengraf]
- sirolimus [Rapamune] (this only includes systemically administered, drug eluting stents are acceptable)
- Anticipated renal transplant within 6 months.
- History of heparin-induced thrombocytopenia.
- Venous outflow from SA cannot be located more centrally than the venous outflow of any previous failed access in that extremity.
- Active local or systemic infection (white blood cells [WBC] > 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least one week post resolution of that infection before SA creation.
- Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.
- Pregnant women, or women intending to become pregnant during the course of the trial.
- Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA.
- Previous enrollment in this study or any other study with HAV.
- Employees of Humacyte and employees or relatives of an investigator.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Surgical Specialists of Charlotte
Charlotte, North Carolina, 28207
The Vascular Experts
Darien, Connecticut, 06820
Decatur Memorial Hospital
Decatur, Illinois, 62526
Denver Health Medical Center
Denver, Colorado, 80204
University of California, Irvine
Irvine, California, 92868
University of Tennessee Knoxville
Knoxville, Tennessee, 37920
University of California San Diego, Jacobs Medical Center
La Jolla, California, 92103
University of CA, San Diego - LaJolla VA Hospital
La Jolla, California, 92161
Alliance Research
Laguna Hills, California, 92653
United Surgical Associates
Lexington, Kentucky, 40504
VA Long Beach Healthcare System
Long Beach, California, 90822
University of Southern California
Los Angeles, California, 90033
South Plains Surgery Center
Lubbock, Texas, 79416
Rutgers University
Newark, New Jersey, 07103
The Regional Medical Center
Orangeburg, South Carolina, 29118
Huntington Hospital
Pasadena, California, 91105
Memorial Healthcare System
Pembroke Pines, Florida, 33021
Coastal Vascular & Interventional, PLLC
Pensacola, Florida, 32503
Arizona Kidney Disease and Hypertension Center (AKDHC)
Phoenix, Arizona, 85012
VA Pittsburgh
Pittsburgh, Pennsylvania, 15213
Kaiser Permanente Sunnsyide
Portland, Oregon, 97015
UC Davis
Sacramento, California, 95817
Balboa Nephrology
San Diego, California, 92123
Mills Peninsula Hospital
San Mateo, California, 94401
Overlook Medical Center
Summit, New Jersey, 07901
Olive View- UCLA Medical Center
Sylmar, California, 91342
Tampa General Hospital
Tampa, Florida, 33606
University of Arizona
Tucson, Arizona, 85724
Kidney Care & Transplant Services of New England
West Springfield, Massachusetts, 01089
About this study
Official title: A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
Read the detailed description
This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative study. Subjects who sign informed consent will undergo study-specific screening assessments within 45 days from the day of informed consent.
Eligible study subjects will be randomized to receive either an HAV or AVF. The randomization will be stratified by upper arm or forearm placement based on the investigator's determination of where the study access (SA) should be located. Subjects will be followed to 24 months post SA creation at routine study visits regardless of patency status. After 24 months, AVF subjects with a patent SA will be followed (while the SA remains patent) for up to 5 years (60 months) post SA creation at routine study visits. After 24 months, HAV subjects will be followed (regardless of SA patency) for 5 years (60 months) post SA creation at routine study visits.
- Conditions
- Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
- Being tested
- Human Acellular Vessel (HAV), Arteriovenous fistula (AVF), Hemodialysis
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Acellular Vessel (HAV)Biological
Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Arteriovenous fistula (AVF)Procedure or surgery
Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
HemodialysisOther
Procedure that filters a person's blood when their kidneys are no longer functioning properly
| Study group | Role | What they receive |
|---|---|---|
| Human Acellular Vessel (HAV) | Experimental | The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. It will be surgically implanted in the forearm or upper arm on Study Day 0. Receives: Biological: Human Acellular Vessel (HAV); Other: Hemodialysis |
| Arteriovenous fistula (AVF) | Active comparator | The comparator is an autologous arteriovenous fistula created in the forearm or upper arm on Study Day 0. Receives: Procedure: Arteriovenous fistula (AVF); Other: Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with functional patency at 6 months post study access (SA) creation
Co-primary endpoint #1: Proportion of subjects with functional patency at 6 months post study access (SA) creation
The definition of "functional patency" is: Dialysis with "2 needles for ≥75% of dialysis sessions over a continuous 4-week period and either: (1) 4 consecutive sessions during the 4-week period in which 2 needles are used and the mean dialysis machine blood pump speed is ≥300 mL/min, or (2) a measured spKt/Vurea is ≥ 1.4 or urea reduction ratio >70% during any session in which 2 needles are used within the 4-week period. SpKt/Vurea is calculated from pre and post-treatment serum urea nitrogen concentrations, body weight, and dialysis session duration."
The functional patency ascertainment period will take place between the 1st day of Week 21 (Day 140) and the last day of Week 26 (Day 181) after AVF creation or HAV placement. The endpoint is met when the functional patency criteria are satisfied within any consecutive 4 week period within this ascertainment period.
Measured: 6 months post SA creation
Proportion of subjects with secondary patency of SA at 12 months post SA creation.
Co-primary endpoint #2: Proportion of subjects with secondary patency of SA at 12 months post SA creation.
The SA maintains secondary patency until it is abandoned, irrespective of interventions to maintain or restore patency.
Abandonment is defined as AVF or HAV that can no longer be used for 2-needle, prescribed dialysis as it may be unable to provide adequate flows and/or is deemed unsafe for the subject, and the associated problem cannot be corrected by any intervention, including medical, surgical, or radiological interventions or rest.
Measured: 12 months post SA creation
Secondary outcomes (13)
Time to loss of secondary patency (abandonment).
Measured: 12, 24, and 60 months post SA creation
Incidence rate of HD access related interventions over the period from SA creation until SA abandonment or 12 months post SA creation
Measured: 12 months post SA creation
Incidence rate of infections related to any HD access in situ over the period from SA creation until 12 months post SA creation, irrespective of SA abandonment.
Measured: 12 months post SA creation
Proportion of subjects with unassisted functional patency at 6 months post SA creation.
Measured: 6 months post SA creation
Incidence rate of HD access-related interventions over the period from SA creation until SA abandonment or the conclusion of the suitability ascertainment period (6 months).
Measured: 6 months post SA creation
Time to loss of primary unassisted patency
Measured: 12, 24, and 60 months post SA creation
Proportion of HD sessions completed via DC (1 or 2 lines) over the period from SA creation until 12 months post SA creation, irrespective of SA abandonment.
Measured: 12 months post SA creation
Number of days with DC in situ "catheter contact time" over the period from SA creation until 12 months post SA creation, irrespective of SA abandonment
Measured: 12 months post SA creation
Histopathological remodeling of HAV and AVF - based on histological examination of SA samples explanted for clinical reasons
Measured: 12, 24, and 60 months post SA creation
Incidence rate of HD access-related infections over the period from SA creation until SA abandonment.
Measured: 12, 24, and 60 months post SA creation
Incidence rate of clinically significant aneurysm or pseudoaneurysm over the period from SA creation until SA abandonment
Measured: 12, 24, and 60 months post SA creation
Incidence rate of SA site infections (CDC definition) over the period from SA creation until SA abandonment.
Measured: 12, 24, and 60 months post SA creation
Frequency and severity of AEs.
Measured: 12, 24, and 60 months post SA creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start29 Sep 2017
- Primary completion22 Apr 2024
- Study completion19 Jun 2025
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 Renal FailureStudies 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
- Masking
- None (open label)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services, California Institute for Regenerative Medicine (CIRM)
- Responsible party
- Sponsor
- Investigators
- Shamik Parikh, MD, Study director, Humacyte, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03183245
- Sponsor's protocol ID
- CLN-PRO-V007
- Status last verified
- Nov 2024
- First submitted
- 8 Jun 2017
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hussain MA, Moore EE, Villa R, Khondker Z, Niklason LE, Parikh S; CLN-PRO-V007 Investigators. Bioengineered acellular tissue engineered vessels versus autogenous fistulae for haemodialysis access: a multicentre, randomised, controlled, phase 3 trial. Lancet Digit Health. 2027 Jun 22:101036. doi: 10.1016/j.landig.2026.101036. Online ahead of print.
PubMed 42613284
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT03183245
- Acronym / sponsor ID
- CLN-PRO-V007
- Conditions
- Renal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CTI Clinical Trial and Consulting Services, California Institute for Regenerative Medicine (CIRM)
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 19 Jun 2025 (actual)
- First posted
- 12 Jun 2017 (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 main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
Detailed description
This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative study. Subjects who sign informed consent will undergo study-specific screening assessments within 45 days from the day of informed consent.
Eligible study subjects will be randomized to receive either an HAV or AVF. The randomization will be stratified by upper arm or forearm placement based on the investigator's determination of where the study access (SA) should be located. Subjects will be followed to 24 months post SA creation at routine study visits regardless of patency status. After 24 months, AVF subjects with a patent SA will be followed (while the SA remains patent) for up to 5 years (60 months) post SA creation at routine study visits. After 24 months, HAV subjects will be followed (regardless of SA patency) for 5 years (60 months) post SA creation at routine study visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Acellular Vessel (HAV) | Experimental | Biological: Human Acellular Vessel (HAV), Other: HemodialysisThe HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. It will be surgically implanted in the forearm or upper arm on Study Day 0. |
| Arteriovenous fistula (AVF) | Active comparator | Procedure: Arteriovenous fistula (AVF), Other: HemodialysisThe comparator is an autologous arteriovenous fistula created in the forearm or upper arm on Study Day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitable for the creation of an AVF or implantation of AVG for HD access.
- Subjects who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 6 months after SA creation.
- Subjects aged at least 18 years at Screening.
- Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight or looped HAV in either the forearm or upper arm.
- Hemoglobin ≥8 g/dL and platelet count ≥100,000 /mm3.
Key exclusion criteria (37 listed)
- Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL of the following criteria:
- Uncontrolled diabetes;
- History or evidence of severe peripheral arterial disease in the extremity selected for implant.
- Known or suspected central vein stenosis or obstruction on the side of planned SA creation, unless corrected prior to randomization.
- Planned AVF creation that requires more than one stage to complete. (e.g. basilic vein transposition AVF performed in 2 stages).
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 |
|---|---|---|
| Human Acellular Vessel (HAV)Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access. | Biological | Human Acellular Vessel (HAV) |
| Arteriovenous fistula (AVF)Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access. | Procedure or surgery | Arteriovenous fistula (AVF) |
| HemodialysisProcedure that filters a person's blood when their kidneys are no longer functioning properly | Other | Arteriovenous fistula (AVF), Human Acellular Vessel (HAV) |
Primary outcome
Proportion of subjects with functional patency at 6 months post study access (SA) creation
Time frame: 6 months post SA creation
Co-primary endpoint #1: Proportion of subjects with functional patency at 6 months post study access (SA) creation The definition of "functional patency" is: Dialysis with "2 needles for ≥75% of dialysis sessions over a continuous 4-week period and either: (1) 4 consecutive sessions during the 4-week period in which 2 needles are used and the mean dialysis machine blood pump speed is ≥300 mL/min, or (2) a measured spKt/Vurea is ≥ 1.4 or urea reduction ratio >70% during any session in which 2 needles are used within the 4-week period. SpKt/Vurea is calculated from pre and post-treatment serum urea nitrogen concentrations, body weight, and dialysis session duration." The functional patency ascertainment period will take place between the 1st day of Week 21 (Day 140) and the last day of Week 26 (Day 181) after AVF creation or HAV placement. The endpoint is met when the functional patency criteria are satisfied within any consecutive 4 week period within this ascertainment period.
Proportion of subjects with secondary patency of SA at 12 months post SA creation.
Time frame: 12 months post SA creation
Co-primary endpoint #2: Proportion of subjects with secondary patency of SA at 12 months post SA creation. The SA maintains secondary patency until it is abandoned, irrespective of interventions to maintain or restore patency. Abandonment is defined as AVF or HAV that can no longer be used for 2-needle, prescribed dialysis as it may be unable to provide adequate flows and/or is deemed unsafe for the subject, and the associated problem cannot be corrected by any intervention, including medical, surgical, or radiological interventions or rest.
13 secondary outcomes
Time to loss of secondary patency (abandonment).
Time frame: 12, 24, and 60 months post SA creation
Incidence rate of HD access related interventions over the period from SA creation until SA abandonment or 12 months post SA creation
Time frame: 12 months post SA creation
Incidence rate of infections related to any HD access in situ over the period from SA creation until 12 months post SA creation, irrespective of SA abandonment.
Time frame: 12 months post SA creation
Proportion of subjects with unassisted functional patency at 6 months post SA creation.
Time frame: 6 months post SA creation
Incidence rate of HD access-related interventions over the period from SA creation until SA abandonment or the conclusion of the suitability ascertainment period (6 months).
Time frame: 6 months post SA creation
Time to loss of primary unassisted patency
Time frame: 12, 24, and 60 months post SA creation
Proportion of HD sessions completed via DC (1 or 2 lines) over the period from SA creation until 12 months post SA creation, irrespective of SA abandonment.
Time frame: 12 months post SA creation
Number of days with DC in situ "catheter contact time" over the period from SA creation until 12 months post SA creation, irrespective of SA abandonment
Time frame: 12 months post SA creation
Histopathological remodeling of HAV and AVF - based on histological examination of SA samples explanted for clinical reasons
Time frame: 12, 24, and 60 months post SA creation
Incidence rate of HD access-related infections over the period from SA creation until SA abandonment.
Time frame: 12, 24, and 60 months post SA creation
Incidence rate of clinically significant aneurysm or pseudoaneurysm over the period from SA creation until SA abandonment
Time frame: 12, 24, and 60 months post SA creation
Incidence rate of SA site infections (CDC definition) over the period from SA creation until SA abandonment.
Time frame: 12, 24, and 60 months post SA creation
Frequency and severity of AEs.
Time frame: 12, 24, and 60 months post SA creation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Derived from this study: PubMed 42613284Hussain MA, Moore EE, Villa R, Khondker Z, Niklason LE, Parikh S; CLN-PRO-V007 Investigators. Bioengineered acellular tissue engineered vessels versus autogenous fistulae for haemodialysis access: a multicentre, randomised, controlled, phase 3 trial. Lancet Digit Health. 2027 Jun 22:101036. doi: 10.1016/j.landig.2026.101036. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Shamik Parikh, MD study director
Humacyte, Inc.
31 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 Human Acellular Vessel (HAV), Arteriovenous fistula (AVF) and Hemodialysis in people with Renal Failure and End Stage Renal Disease, run by Humacyte, Inc. at 31 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 15 inclusion and 37 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: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects with functional patency at 6 months post study access (SA) creation (time frame: 6 months post SA creation). 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 NCT03183245, 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 20 Nov 2025.