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

NCT02644941 | Completed Phase 3 Results DMC

• 2 other identifiers: CLN-PRO-V0062015-003261-28
• Study Type: interventional
• Target: 355
• Locations: 6 countries
• Sites: 38

Brief Summary

The main purpose of this study is to compare the Human Acellular Vessel (HAV) with ePTFE grafts when used for hemodialysis access.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Loss of Secondary Patency

  1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).

  12 months post-implantation

• Number of Participants With Loss of Secondary Patency

  1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).

  18 months post-implantation

• Number of Participants With Loss of Secondary Patency

  1. Defined as 'the interval from the time of access placement until access abandonment', i.e., patent with or without interventions (Sidawy et al. 2002). 2. "Abandonment" defined as no remaining segment of the study conduit was incorporated into the vascular access circuit used for dialysis (conversely, if some portion of the study conduit was still being used for dialysis it was not considered abandoned).

  24 months post-implantation

Secondary Outcomes (29)

• Number of Participants With Loss of Primary Patency

  12 months post-implantation

• Number of Participants With Loss of Primary Patency

  18 months post-implantation

• Number of Participants With Loss of Primary Patency

  24 months post-implantation

• Number of Participants With Loss of Primary Patency

  60 months post-implantation

• Study Conduit Abandonment

  24 months post-implantation

Study Arms (2)

Human Acellular Vessel (HAV)

EXPERIMENTAL

HAV-tissue-engineered vascular conduit (6mm diameter)

Biological: Human Acellular Vessel (HAV)

ePTFE

ACTIVE COMPARATOR

One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)

Device: ePTFE graft

Interventions

Human Acellular Vessel (HAV) BIOLOGICAL

HAV-tissue-engineered vascular conduit (6mm diameter)

Also known as: (regulated as a biological product)

Human Acellular Vessel (HAV)

ePTFE graft DEVICE

One of two commercially available comparators (Bard Impra® and Gore PROPATEN®)

ePTFE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with ESRD who need placement of an AV graft in the arm.
• Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation.
• Suitable anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow).
• Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 0 (within 35 days).
• Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 35 days).
• Adequate liver function prior to Day 0 (within 35 days).
• Female subjects must be either:
• Of non-childbearing potential Or
• Must agree to use at least one form of birth control methods for the duration of the study.
• Subject, or legal representative, able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.
• Life expectancy of at least 1 year.

You may not qualify if:

• History or evidence of severe peripheral vascular disease in the intended arm for implantation.
• Known or suspected central vein stenosis or conduit occlusion on the ipsilateral side of planned implantation, unless the stenosis is corrected prior to study conduit implantation.
• Treatment with any investigational drug or device within 60 days prior to study entry (Day 0).
• Cancer that is actively being treated with a cytotoxic agent.
• Documented hyper-coagulable state.
• Bleeding diathesis.
• Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
• High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
• Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
• tacrolimus or FK506 \[Prograf\]
• mycophenolate mofetil \[Cellcept\],
• Anticipated renal transplant within 6 months.
• Venous outflow from study conduit cannot be placed more centrally than the venous outflow of any previous failed access in that extremity.
• Active local or systemic infection (white blood cells \[WBC\] \> 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least one week post resolution of that infection before implantation.
• Known serious allergy to planned antiplatelet agent.

Sponsors & Collaborators

• Humacyte, Inc.: lead
• CTI Clinical Trial and Consulting Services: collaborator
• California Institute for Regenerative Medicine (CIRM): collaborator

Study Sites (38)

Arizona Kidney Disease and Hypertension Center (AKDHC)

Phoenix, Arizona, 85012, United States

Location

Carondelet St. Mary's Hospital

Tucson, Arizona, 85745, United States

Location

Ladenheim Dialysis Access Center

Fresno, California, 93710, United States

Location

General Surgery and Vascular Access

Fresno, California, 93720, United States

Location

University of California Irvine (UCI) Medical Center

Irvine, California, 92868, United States

Location

VA Long Beach Healthcare System

Long Beach, California, 90822, United States

Location

VA Sacramento Medical Center

Mather, California, 95655, United States

Location

Balboa Nephrology

San Diego, California, 92123, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Southwest Vascular Access Center

Alsip, Illinois, 60803, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Michigan Cardiovascular Institute

Flint, Michigan, 48507, United States

Location

Greenwood Leflore Hospital

Greenwood, Mississippi, 38930, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Rutgers-New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

The Cardiovascular Care Group

Westfield, New Jersey, 07090, United States

Location

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Kaiser Permanente

Portland, Oregon, 97201, United States

Location

Medical University of South Carolina (MUSC)

Orangeburg, South Carolina, 29118, United States

Location

Baylor Scott and White Research Institute

Dallas, Texas, 75226, United States

Location

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Universitätsklinikmn Erlangen, Gefäßchirurgie - Chirurgisches Zentrum

Erlangen, Bavaria, 91054, Germany

Location

Universitätsklinikum Frankfurt Klinik für Gefäß- und Endovascular-Chirurgie

Frankfurt am Main, Hesse, 60590, Germany

Location

The Chaim Sheba Medical Center

Ramat Gan, Tel Aviv, 52621, Israel

Location

Hillel Jaffe Medical Center

Hadera, 38100, Israel

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Sharee Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Yitzhak Shamir Medical Center - Assaf Harofeh

Tzrifin, 70300, Israel

Location

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

Poznan, 61-848, Poland

Location

Samodzielny Publiczyn Centralny Szpital Klinziczny w Warszawie - Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

Warsaw, 02-097, Poland

Location

Wojewódzki Szpital Specjalistyczny we Wrocławiu

Wroclaw, 51-124, Poland

Location

Grupo de Estudos Vasculares

Porto, 4050-190, Portugal

Location

Leicester General Hospital

Leicester, East Midlands/ Leicestershire, LE5 4PW, United Kingdom

Location

Guy´s Hospital, Kings´College London

London, Greater London, SE1 9RT, United Kingdom

Location

Queen Elizabeth Hospital Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Queen Elizabeth University Hospital Glasgow

Glasgow, G51 4TF, United Kingdom

Location

Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

Location

Related Publications (1)

• Wang J, Blalock SKF, Levitan GS, Prichard HL, Niklason LE, Kirkton RD. Biological mechanisms of infection resistance in tissue engineered blood vessels compared to synthetic expanded polytetrafluoroethylene grafts. JVS Vasc Sci. 2023 Jul 14;4:100120. doi: 10.1016/j.jvssci.2023.100120. eCollection 2023.

  PMID: 37662589 DERIVED

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

Interventions

Social Control, Formal

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Care Economics and Organizations

Results Point of Contact

• Title: Shamik Parikh, Chief Medical Officer
• Organization: Humacyte Global Inc

sparikh@humacyte.com

919-313-9633

Study Officials

• Shamik Parikh, MD

  Humacyte, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 1, 2016
• Study Start: May 24, 2016
• Primary Completion: May 1, 2019
• Study Completion: September 1, 2023
• Last Updated: March 30, 2025
• Results First Posted: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (22); PT (1); IL (5); DE (2); GB (5); PL (3)