To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
← catalyst calendarNCT05908084 · readout ≤ 315 d
Sponsored by Humacyte, Inc. (industry) · HUMA — their whole pipeline →. With IQVIA Biotech.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
121actual
Sites
32
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-09-07 | actual | When the study began enrolling |
| Primary completion | Jun 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2023-06-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-26 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- End Stage Renal Disease (ESRD)
Interventions
- Biological: Acellular Tissue Engineered Vessel (ATEV) — also filed as Human Acellular Vessel (HAV)
- Other: AVF
Primary outcomes
what the primary-completion date above is the date OFThe number of catheter-free days since randomization to Month 12.
measured 12 months
The rate of infections related to any HD access.
measured 12 months
Publications
- PMID 42319856 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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