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

StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion date: Oct 2026 to Jun 2027v10 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 150 to confirmed 121
    • Study completion date: Oct 2027 to Jun 2028
    • Site details revised at 32 of 32 sites
  2. Study sites: 25 to 32v9 Show 5 more changesShow less
    • Interventions: AVF (Other), HAV (Biological) to AVF (Other), Acellular Tissue Engineered Vessel (ATEV) (Biological)
    • Eligibility criteria revised
    • Study description expanded, about 13 words
    • Study title revised
    • Collaborators expanded, about 2 words
  3. Primary completion date: Oct 2025 to Oct 2026v8
  4. Study sites: 17 to 25v7
  5. Site contacts updated at 17 of 17 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 11 to 17v5
  2. Study sites: 2 to 11v4
  3. Study sites: 1 to 2v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2023 to Sep 7, 2023
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05908084
Lead Sponsor Humacyte, Inc.
Collaborators: IQVIA Biotech
Conditions
(from sponsor)		 End Stage Renal Disease (ESRD)
Related terms Kidney Failure, Chronic
Enrollment 121 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov