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RECRUITING Phase 3

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

NCT05908084 · View on ClinicalTrials.gov ↗

Study Summary

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).

Interventions

  • BIOLOGICAL Acellular Tissue Engineered Vessel (ATEV)
  • OTHER AVF

Study Locations (20)

Florida

  • Access Research Institute — Brooksville
  • University of FL Health Heart and Vascular Hospital — Gainesville
  • Mayo Clinic Florida — Jacksonville
  • American Access Care of Miami, LLC — Miami
  • USF Health South Tampa — Tampa

New Jersey

  • Rutgers University_Medical — Newark
  • St.Joseph's University Medical Center — Paterson
  • Capital Health Medical Center- Hopewell — Pennington

California

  • El Centro Regional Medical Center — El Centro
  • Jacob's Medical Center at UC San Diego Health — La Jolla

Georgia

  • Georgia Nephrology — Atlanta
  • Grady Memorial Hospital — Atlanta

Massachusetts

  • Brigham and Women's Hospital — Boston
  • Boston Medical Center — Boston

Arizona

  • Honor Health Scottsdale Shea Medical Center — Scottsdale

Colorado

  • Denver Health and Hospital Authority — Denver

Connecticut

  • Yale New Haven Hospital — New Haven

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2023-09-07
Est. Completion 2027-10
Phase Phase 3

Sponsor

Humacyte

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05908084

The ClinicalTrials.gov registry entry for NCT05908084 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Humacyte, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with End Stage Renal Disease (ESRD) appearing as the primary indexed condition, and to 2 interventions — of which Acellular Tissue Engineered Vessel (ATEV) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05908084 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, New Jersey, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05908084 about?

NCT05908084 is a clinical study titled "To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis". 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 str...

What is the current status of trial NCT05908084?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2023-09-07. Estimated completion is 2027-10.

What conditions does trial NCT05908084 study?

This clinical trial studies the following conditions: End Stage Renal Disease (ESRD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05908084?

The interventions under investigation include: Acellular Tissue Engineered Vessel (ATEV) (BIOLOGICAL), AVF (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05908084?

This trial is sponsored by Humacyte, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05908084 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial