At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 355 enrolled
Drug / intervention
Human Acellular Vessel (HAV) +1 morebiological
Likely dose
Human Acellular Vessel 6mm diameterAI-extracted
Key inclusion· 6
- ✓ESRD requiring AV graft placement in the arm
- ✓On hemodialysis or expected to start within 12 weeks of implantation
- ✓Suitable arm anatomy for straight or looped conduit in forearm or upper arm (not crossing elbow)
- ✓Hemoglobin ≥8 g/dL and platelets ≥100,000 cells/mm3 within 35 days
Key exclusion· 13
- ✕Severe peripheral vascular disease in intended arm
- ✕Central vein stenosis or ipsilateral conduit occlusion unless corrected prior to implantation
- ✕Any investigational drug or device within 60 days
- ✕Active cytotoxic cancer treatment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Assessment of Humacyte's Human Acellular Vessel in Patients Needing Renal Replacement Therapy: A Comparison With ePTFE Grafts as Conduits for Hemodialysis (HUMANITY)
In Brief
A Phase 3 clinical trial evaluating Human Acellular Vessel (HAV) and ePTFE graft for Renal Failure and 3 related conditions. Completed, enrolled 355 participants across 38 sites in 6 countries.
Detailed Summary
The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRenal Failure, End Stage Renal Disease, Hemodialysis, Vascular Access
CountriesGermany, Israel, Poland, Portugal, United Kingdom, United States
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartMay 2016
Primary CompletionMay 2019
Study CompletionSep 2023
TodayJul 2026
First PostedJan 1, 2016
Enrollment StartMay 24, 2016
Primary CompletionMay 1, 2019
Study CompletionSep 1, 2023
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 10.5 years ago
Interventions
Human Acellular Vessel (HAV)biological
HAV-tissue-engineered vascular conduit (6mm diameter)
ePTFE graftdevice
One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)