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Study identifier: NCT05908084 Synced from ClinicalTrials.gov · August 05, 2026
● Active Not Recruiting

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

Condition: End Stage Renal Disease (ESRD)  ·  Sponsor: Humacyte, Inc.

PhasePhase 3
Planned participants121
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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).

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (32)

Honor Health Scottsdale Shea Medical CenterScottsdale, Arizona, United States
El Centro Regional Medical CenterEl Centro, California, United States
Jacob's Medical Center at UC San Diego HealthLa Jolla, California, United States
Denver Health and Hospital AuthorityDenver, Colorado, United States
Yale New Haven HospitalNew Haven, Connecticut, United States
Access Research InstituteBrooksville, Florida, United States
University of FL Health Heart and Vascular HospitalGainesville, Florida, United States
Mayo Clinic FloridaJacksonville, Florida, United States
American Access Care of Miami, LLCMiami, Florida, United States
USF Health South TampaTampa, Florida, United States
Georgia NephrologyAtlanta, Georgia, United States
Grady Memorial HospitalAtlanta, Georgia, United States

+ 20 more locations — full list on the registry record.

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