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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: Recruiting Phase 3 study of End Stage Renal Disease (ESRD), sponsored by Humacyte.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2023-09-07 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
What NCT05908084 shows while recruiting
NCT05908084 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 361-participant average among 10 other End Stage Renal Disease (ESRD) trials with a reported enrollment target (58% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05908084's enrollment target sits among peer trials
150 2nd of 10 higher than 8 of 10 other End Stage Renal Disease (ESRD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other End Stage Renal Disease (ESRD) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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