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NCT03183245 · ClinicalTrials.gov registry record · Phase 3
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
A Phase 3 study, sponsored by Humacyte.
- Completed
- Registry status
- Phase 3
- Development phase
- 242
- Enrollment target
NCT03183245: Completed Phase 3 study, sponsored by Humacyte.
NCT03183245 is a Phase 3 study that has completed, run by Humacyte. The registered enrollment target is 242 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03183245, a Phase 3 study, has completed, sponsored by Humacyte.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 242 participants
- Enrollment target
Study Summary
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
Primary Outcome
Co-primary endpoint #1: Proportion of subjects with functional patency at 6 months post study access (SA) creation The definition of "functional patency" is: Dialysis with "2 needles for ≥75% of dialysis sessions over a continuous 4-week period and either: (1) 4 consecutive sessions during the 4-week period in which 2 needles are used and the mean dialysis machine blood pump speed is ≥300 mL/min, or (2) a measured spKt/Vurea is ≥ 1.4 or urea reduction ratio \>70% during any session in which 2 n
Interventions
- BIOLOGICAL Human Acellular Vessel (HAV)
- OTHER Hemodialysis
- PROCEDURE Arteriovenous fistula (AVF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 242 participants |
| Start Date | 2017-09-29 |
| Est. Completion | 2025-06-19 |
| Phase | Phase 3 |
What the finished NCT03183245 record still lists
NCT03183245 is an interventional study that assigns participants to a tested intervention. The registered 242 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 3 interventions - of which Human Acellular Vessel (HAV) is the first listed.
NCT03183245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03183245 about?
NCT03183245 is a clinical study titled "Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis". The main purpose of this study is to compare the Human Acellular Vessel (HAV) with arteriovenous fistula (AVF) when used for hemodialysis access
What is the current status of trial NCT03183245?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 242 participants. The study started on 2017-09-29. Estimated completion is 2025-06-19.
What interventions are being tested in trial NCT03183245?
The interventions under investigation include: Human Acellular Vessel (HAV) (BIOLOGICAL), Hemodialysis (OTHER), Arteriovenous fistula (AVF) (PROCEDURE).
Who is sponsoring clinical trial NCT03183245?
This trial is sponsored by Humacyte, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03183245's enrollment target sits among peer trials
242 1270th of 2000 higher than 729 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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