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Acellular Tissue Engineered Vessel

Phase 3

End Stage Renal Disease (ESRD) | Monoclonal antibody | Nephrology |Humacyte, Inc.|Last Updated: Jun 26, 2026

Success Probability
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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment121
FDA Designations
No designations recorded
Clinical trial landscape

Acellular Tissue Engineered Vessel · 1 trial · 1 indication

Phase 3 1
NCT05908084To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring HemodialysisEnd Stage Renal Disease (ESRD)
ACTIVE NOT_RECRUITING121 Analytics
PHASE3ACTIVE NOT_RECRUITING
To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
End Stage Renal Disease (ESRD)
NCT05908084121
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Study Endpoints
Primary Endpoints
The number of catheter-free days since randomization to Month 12.
12 months

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.

The rate of infections related to any HD access.
12 months

To determine the rate of infections, related to any HD access over the period from SA creation (Day 1) until 12 months (365 days) after SA placement, without regard to SA abandonment.

Secondary Endpoints
The number of catheter-free days since randomization to Month 6.
6 months
The number of days of the study access (SA) functional patency
12 months
The rate of the study access (SA) secondary patency
6 - 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATEV treatment armEXPERIMENTALATEV will be implanted as an arterio-venous (AV) access into the forearm or upper arm
AVF treatment armACTIVE_COMPARATORAVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm
Interventions
NameTypeDescription
Acellular Tissue Engineered Vessel (ATEV)BIOLOGICALATEV implantation
AVFOTHERAVF creation procedure
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Eligibility Criteria
Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: 1. Female patients with ESRD, currently receiving hemodialysis via dialysis catheter and who are candidates for the creation of an AVF (see Inclusion Criterion #4 below) or implantation of an ATEV for HD access. 2. Patients who plan to undergo HD at a dialysis unit of a particip...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMJun 26, 2026NCT05908084Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 26, 2026NCT05908084Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT05908084primaryCompletionDate: changed
LOWMay 24, 2026NCT05908084studyFirstPostDate: changed