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NCT05908084 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of End Stage Renal Disease (ESRD), sponsored by Humacyte.

Recruiting
Registry status
Phase 3
Development phase
150
Enrollment target
20
Study locations

NCT05908084 is a Phase 3 study of End Stage Renal Disease (ESRD) that is actively recruiting participants, run by Humacyte. The registered enrollment target is 150 participants, below the 361-participant average among 10 other End Stage Renal Disease (ESRD) trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT05908084, a Phase 3 study of End Stage Renal Disease (ESRD), is actively recruiting participants, sponsored by Humacyte.

RECRUITING
Registry status
Phase 3
Development phase
150 participants
Enrollment target
20
Study locations

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).

Conditions Studied

End Stage Renal Disease (ESRD)

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

6 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, categorized as Phase 3. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 361-participant average among 10 other End Stage Renal Disease (ESRD) trials with a reported enrollment target (58% lower). The listed sponsor is Humacyte, which has 6 total studies on file at ClinicalTrials.gov.

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.

NCT05908084 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, New Jersey, California.

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).

What interventions are being tested in trial NCT05908084?

The interventions under investigation include: Acellular Tissue Engineered Vessel (ATEV) (BIOLOGICAL), AVF (OTHER).

Who is sponsoring clinical trial NCT05908084?

This trial is sponsored by Humacyte, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.