Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease
The purpose of this study is to assess the safety and efficacy of a novel, tissue-engineered vascular prosthesis, the Human Acellular Vascular Graft, HAVG.
The HAVG is intended as an alternative to synthetic materials and to autologous grafts in the creation of vascular access for dialysis.
End-stage Renal Disease
Kidney Failure, Chronic
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vascular Graft for Use as a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease|
- HAVG graft assessment [ Time Frame: From baseline to week 26 after HAVG implantation. ] [ Designated as safety issue: Yes ]The incidence of aneurysm formation, anastomotic bleeding or rupture, graft infection and irritation/inflammation/infection at the implantation site will be assessed by Doppler ultrasound and tabulated.
- HAVG patency rate [ Time Frame: at Week 26 after HAVG implantation ] [ Designated as safety issue: No ]Determine the patency (primary, primary assisted and secondary) rate of the Humacyte HAVG by Doppler ultrasound.
- Adverse Events [ Time Frame: From baseline to week 26 after HAVG implantation. ] [ Designated as safety issue: Yes ]Frequency and severity of AEs of each patient will be documented.
- HAVG graft interventions [ Time Frame: From baseline to week 26 after HAVG implantation. ] [ Designated as safety issue: Yes ]Graft interventions of each patient will be documented.
- Change from baseline in Panel Reactive Antibody [ Time Frame: From baseline to day 29, weeks 12 and 26 after HAVG implantation. ] [ Designated as safety issue: Yes ]Assess changes in the Panel Reactive Antibody response over the 6 months after graft implantation.
- Development of IgG antibodies [ Time Frame: From baseline to day 29, weeks 12 and 26 after HAVG implantation. ] [ Designated as safety issue: Yes ]Determine whether IgG antibodies to the extracellular matrix material are formed in response to implantation of the HAVG.
- Graft interventions [ Time Frame: At each visit, i.e. day 1, day 4-7, day 15, day 29, day 57, week 12, week 16, 20, 26 after HAVG implantation. ] [ Designated as safety issue: No ]Determine the rates of interventions needed to maintain / restore patency in the graft.
- HAVG patency rates [ Time Frame: at 12, 18, 24 months after HAVG implantation. ] [ Designated as safety issue: No ]Patency rates (primary, primary assisted, and secondary)
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Surgical placement of HAVG
HAVG is implanted into patients' arm.
The HAVG is a sterile, non-pyrogenic, acellular tubular graft composed of human collagens and other natural extra-cellular matrix proteins. Upon implantation, it is anticipated (based on pre-clinical studies) that the collagen-based matrix comprising the graft will be infiltrated with host cells and re-modeled by the host. This will result in a vascular structure more similar to the histological composition of the native vascular tissue that may improve graft longevity and be less likely to become infected.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01840956
|United States, North Carolina|
|Duke University Medical Center Department of Vascular Surgery|
|Durham, North Carolina, United States, 27710|
|United States, Texas|
|The Methodist Hospital|
|Houston, Texas, United States, 77030|
|United States, Virginia|
|Sentara Norfolk General Hospital Vascular & Transplant Specialists|
|Norfolk, Virginia, United States, 23507|
|Principal Investigator:||Jeffrey H Lawson, MD PhD||Department of Vascular Surgery Duke University Medical Center|