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Donated artery grafts tested as lifeline for dialysis patients

NCT ID NCT05880537

Disease control Sponsor: LifeNet Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

People with end-stage kidney disease need a reliable way to connect to a dialysis machine, and their own veins sometimes cannot handle it. This study follows about 100 adults who receive a decellularized human femoral artery graft, a donated blood vessel stripped of living cells, to create that access. Researchers use ultrasound to check whether the graft stays open and carries blood flow, and they track problems at the access site. The goal is to see how well this graft performs as a dialysis access option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a decellularized human femoral artery allograft used to create dialysis access
What this could lead to
If it holds up, this graft could give people on dialysis another option for access when their own veins are not usable.
What could go wrong
This is a registry study, not a randomized trial, so it can show patterns but not prove the graft beats other options. Grafts can clot, narrow, or get infected, and some may fail early.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Be male or female, ≥18 years of age at the time of graft placement 2. Have a diagnosis of ESRD or renal dysfunction requiring hemodialysis 3. Subject requires dialysis access to start or maintain dialysis treatment and placement of an AV access graft is a viable access option. 4. 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 5. Have provided written authorization for use and disclosure of protected health information Exclusion Criteria: 1. Be participating in a study of another investigational drug or device 2. 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) 3. Have a history or evidence of severe cardiac disease, myocardial infarction within 6 months, ventricular arrhythmias, or unstable angina requiring continuing treatment 4. Have a history or evidence of severe peripheral vascular disease in the upper extremities 5. Have the inability or be unable or unwilling to follow the study visit schedule 6. 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

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End-stage renal disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Harbor-UCLA Medical Center

    RECRUITING

    Torrance, California, 90502, United States

  • Infirmary Heath

    RECRUITING

    Mobile, Alabama, 36607, United States

  • Olive View - UCLA Medical Center

    RECRUITING

    Sylmar, California, 91342, United States

  • Sentara Norfolk General Hospital

    RECRUITING

    Norfolk, Virginia, 23507, United States

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