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Comparing ATEV and AVF for Hemodialysis in Women with End-Stage Kidney Disease

This study is comparing two ways to create access for hemodialysis (a treatment for kidney failure) in women with end-stage kidney disease. It's looking at an Acellular Tissue Engineered Vessel (ATEV) and a standard AVF (arteriovenous fistula) creation procedure. The main goals are to see how many days you can go without needing a catheter (a tube for dialysis) and to track any infections related to your dialysis access over 12 months. You might be able to join if you are a woman with end-stage kidney disease, are currently on hemodialysis using a catheter, and are a candidate for either an AVF or ATEV. The study is currently unclear on its recruitment status.

Study design
This is a randomized study, meaning participants will be assigned by chance to receive either the ATEV or AVF. About 150 female patients will participate.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
All patients will be followed for 12 months. If your access is still working at 12 months, you will be followed for an additional 12 months in a long-term study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05908084

To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
Humacyte, Inc.
~121 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:Acellular Tissue Engineered Vessel (ATEV)AVF

At a glance

Recruiting sites
0 of 32 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of catheter-free days since randomization to Month 12.
Measured over 12 months
+1 more outcome measured

Conditions

End Stage Renal Disease (ESRD)

Explore related trials

Chronic Kidney Disease, Stage 5

Where it's being run

32 sites across 16 states
Florida5
Texas5
New Jersey3
North Carolina3
California2
Georgia2
Massachusetts2
New York2

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Vein diameter
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. 5. Hemoglobin ≥ 7 g/dL and platelet count ≥ 100,000 /mm3 6. Patients must either:

What this trial measures

  • The number of catheter-free days since randomization to Month 12.12 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.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.