End-Stage Renal DiseaseNCT05880537
Decellularized Femoral Artery Allograft (Nexeon AVX) Prospective Registry
An observational study of End-Stage Renal Disease, run by LifeNet Health at 4 sites in United States.
Trial summary
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery, Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- Nexeon Arterial Venous Allograft
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Jun 2023to 15 Dec 2028
- How long will I take part?
- 24 Months
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The registry subject population will consist of male and female research subjects, 18 years of age or older at the time of graft placement, who require vascular access for hemodialysis that the surgeon determines, in their medical judgement, to be a candidate to receive the Nexeon AVX graft. The target study enrollment is 100 subjects. Each subject will be followed for a maximum of two (2) years or 24 months post-graft placement.
Who may be able to join
- Be male or female, ≥18 years of age at the time of graft placement
- Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis
- Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option.
- Have the ability themselves, or through their legal guardian, to understand the requirements of the study, to provide written informed consent/assent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and to agree to abide by the study restrictions and return to the site for the required assessments
- Have provided written authorization for use and disclosure of protected health information
Who cannot join
- Be participating in a study of another investigational drug or device
- Have a known sensitivity to any of the processing reagents utilized in the manufacture of this product such as antibiotics (Lincomycin, Polymyxin B, Ciprofloxacin, Meropenum, Gentamicin, or Vancomycin) and processing reagents (N-lauroyl sarcosine, Denarase and glycerol/glycerin)
- Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment
- Have a history or evidence of severe peripheral vascular disease in the upper extremities
- Have the inability or be unable or unwilling to follow the study visit schedule
- Have the presence of any condition that, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Infirmary Heath
Mobile, Alabama, 36607
Wendy Blount, MSN, 251-435-5931, wendy.blount@infirmaryhealth.org
Cullen McCarthy, MD
- Recruiting
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Amanda Anderson, 757-388-2407, aganders@sentara.com
Animesh Rathore, MD
- Recruiting
Olive View - UCLA Medical Center
Sylmar, California, 91342
Rosario Machicado, 747-210-8811, rmachicado@dhs.lacounty.gov
Warren Chow, MD
- Recruiting
Harbor-UCLA Medical Center
Torrance, California, 90502
Elizabeth Hernandez, 949-422-6701, ehernandez@lundquist.org
Rowena Buwalda, 949-422-6701, rbuwalda@dhs.lacounty.gov
About this study
Official title: Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
Read the detailed description
The clinical objective of this prospective, observational, post market registry study, CR-21-005, is to assess the safety and efficacy of a decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery, LifeNet Health, Virginia Beach, VA) in the creation of vascular access for hemodialysis in patients with ESRD.
- Conditions
- End-Stage Renal Disease
- Being tested
- Nexeon Arterial Venous Allograft
- 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.
Nexeon Arterial Venous AllograftOther
Nexeon AVX allograft for hemodialysis access in end stage renal disease
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Open Label for subjects with End-Stage Renal Disease Receives: Other: Nexeon Arterial Venous Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
UltraSound evaluation of allograft functional patency.
Ultrasound proof of vessel patency and blood flow
Measured: 24 months
Secondary outcomes (1)
Secondary Endpoint:
Evaluating the emergent adverse events as it pertains to the hemodialysis access anatomical site
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start6 Jun 2023
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- LifeNet Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05880537
- Sponsor's protocol ID
- CR-21-005
- Status last verified
- Sep 2026
- First submitted
- 1 Mar 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Efficacy, & Use of Decellularized Femoral Artery Allograft for Arteriovenous Access for Hemodialysis: A Multi-center Prospective Registry Study
- ClinicalTrials.gov ID
- NCT05880537
- Acronym / sponsor ID
- CR-21-005
- Conditions
- End-Stage Renal Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LifeNet HealthIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 30 May 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.
Post market registry to assess the safety and efficacy of a novel decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery,
Detailed description
The clinical objective of this prospective, observational, post market registry study, CR-21-005, is to assess the safety and efficacy of a decellularized human femoral artery allograft (Nexeon AVX Decellularized Femoral Artery, LifeNet Health, Virginia Beach, VA) in the creation of vascular access for hemodialysis in patients with ESRD.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label | – | Other: Nexeon Arterial Venous AllograftOpen Label for subjects with End-Stage Renal Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The registry subject population will consist of male and female research subjects, 18 years of age or older at the time of graft placement, who require vascular access for hemodialysis that the surgeon determines, in their medical judgement, to be a candidate to receive the Nexeon AVX graft. The target study enrollment is 100 subjects. Each subject will be followed for a maximum of two (2) years or 24 months post-graft placement.
Key inclusion criteria (5 listed)
- Be male or female, ≥18 years of age at the time of graft placement
- Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis
- Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option.
- Have the ability themselves, or through their legal guardian, to understand the requirements of the study, to provide written informed consent/assent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and to agree to abide by the study restrictions and return to the site for the required assessments
- Have provided written authorization for use and disclosure of protected health information
Key exclusion criteria (6 listed)
- Be participating in a study of another investigational drug or device
- Have a known sensitivity to any of the processing reagents utilized in the manufacture of this product such as antibiotics (Lincomycin, Polymyxin B, Ciprofloxacin, Meropenum, Gentamicin, or Vancomycin) and processing reagents (N-lauroyl sarcosine, Denarase and glycerol/glycerin)
- Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment
- Have a history or evidence of severe peripheral vascular disease in the upper extremities
- Have the inability or be unable or unwilling to follow the study visit schedule
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 |
|---|---|---|
| Nexeon Arterial Venous AllograftNexeon AVX allograft for hemodialysis access in end stage renal disease | Other | Open Label |
Primary outcome
UltraSound evaluation of allograft functional patency.
Time frame: 24 months
Ultrasound proof of vessel patency and blood flow
1 secondary outcome
Secondary Endpoint:
Time frame: 24 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 15 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for End-Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-Stage Renal Disease, run by LifeNet Health at 4 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
Contact Kimberly Dorsch (757-609-4378, kimberly_dorsch@lifenethealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UltraSound evaluation of allograft functional patency. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.