Humacyte at ASN Kidney Week: Phase 3 Trial Built for Women Shows ATEV Advantage Over Fistula, Getting Patients Off Catheters Months Sooner
Humacyte presented positive interim results from the V012 Phase 3 trial at ASN Kidney Week, showing its ATEV beat AV fistula on the primary endpoint of catheter-free days in female hemodialysis patients. Women implanted with the ATEV averaged 220.4 catheter-free days in year one versus 129.3 with a fistula (p<0.001), reached usable access in a median of 1.7 months versus 5.3 months, and had fewer access infections (6 vs 23 per 100 patient-years). The trial met its primary endpoint and enrollment was stopped early.
Key figures
- Drug Name
- Symvess (ATEV / acellular tissue engineered vessel)
- Phase Of Trial
- Phase 3
- Planned enrollment
- 150
- Catheter free days atev
- 220.4
- P value primary endpoint
- p<0.001
- Interim analysis patients
- 80
- Catheter free days fistula
- 129.3
- Fistula maturation rate month12 pct
- 65
- Infections atev per 100 patient years
- 6
- Infections fistula per 100 patient years
- 23
- Median time to functional access atev months
- 1.7
- Median time to functional access fistula months
- 5.3
AI analysis
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