NCT03183245Phase 3Completed

Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-04-22Actual

Enrollment · participants242Actual

Source updated2025-11-20Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2025-11-20 · 3 fields changed

Participant count type

Recorded edit

− Previous value

Estimated

+ Updated value

Actual

Enrollment · participant count

Recorded edit

− Previous value

count: 240; type: ESTIMATED

+ Updated value

count: 242; type: ACTUAL

Recruitment status

Recorded edit

− Previous value

Active not recruiting

+ Updated value

Completed

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Study details

Conditions studied

Renal Failure; End Stage Renal Disease; Hemodialysis; Vascular Access

Treatments or interventions studied

Human Acellular Vessel (HAV)Biological

Primary outcomes · main study measures

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measure: Proportion of subjects with functional patency at 6 months post study access (SA) creation; description: 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 needles are used within the 4-week period. SpKt/Vurea is calculated from pre and post-treatment serum urea nitrogen concentrations, body weight, and dialysis session duration." The functional patency ascertainment period will take place between the 1st day of Week 21 (Day 140) and the last day of Week 26 (Day 181) after AVF creation or HAV placement. The endpoint is met when the functional patency criteria are satisfied within any consecutive 4 week period within this ascertainment period.; timeFrame: 6 months post SA creation; measure: Proportion of subjects with secondary patency of SA at 12 months post SA creation.; description: Co-primary endpoint #2: Proportion of subjects with secondary patency of SA at 12 months post SA creation. The SA maintains secondary patency until it is abandoned, irrespective of interventions to maintain or restore patency. Abandonment is defined as AVF or HAV that can no longer be used for 2-needle, prescribed dialysis as it may be unable to provide adequate flows and/or is deemed unsafe for the subject, and the associated problem cannot be corrected by any intervention, including medical, surgical, or radiological interventions or rest.; timeFrame: 12 months post SA creation

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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