To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
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).
Timeline
- Start
- 2023-09-07
- Primary completion
- 2027-06
- Completion
- 2028-06
Outcome
Met primary endpoint
release “positive top-line results from the V007 Phase 3 Clinical Trial of the acellular tissue engineered vessel (ATEV)” humacyte.com ↗
release “the ATEV demonstrated superior function and patency at six and 12 months (co-primary endpoints) compared to autogenous fistula” humacyte.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acellular Tissue Engineered Vessel (ATEV) | Unknown | — | Other |