Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
NCT ID: NCT03183245
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
242 participants
INTERVENTIONAL
2017-09-29
2025-06-19
Brief Summary
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Detailed Description
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Eligible study subjects will be randomized to receive either an HAV or AVF. The randomization will be stratified by upper arm or forearm placement based on the investigator's determination of where the study access (SA) should be located. Subjects will be followed to 24 months post SA creation at routine study visits regardless of patency status. After 24 months, AVF subjects with a patent SA will be followed (while the SA remains patent) for up to 5 years (60 months) post SA creation at routine study visits. After 24 months, HAV subjects will be followed (regardless of SA patency) for 5 years (60 months) post SA creation at routine study visits.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Human Acellular Vessel (HAV)
The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. It will be surgically implanted in the forearm or upper arm on Study Day 0.
Human Acellular Vessel (HAV)
Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Hemodialysis
Procedure that filters a person's blood when their kidneys are no longer functioning properly
Arteriovenous fistula (AVF)
The comparator is an autologous arteriovenous fistula created in the forearm or upper arm on Study Day 0.
Arteriovenous fistula (AVF)
Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Hemodialysis
Procedure that filters a person's blood when their kidneys are no longer functioning properly
Interventions
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Human Acellular Vessel (HAV)
Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Arteriovenous fistula (AVF)
Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
Hemodialysis
Procedure that filters a person's blood when their kidneys are no longer functioning properly
Eligibility Criteria
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Inclusion Criteria
2. Subjects who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 6 months after SA creation.
3. Subjects aged at least 18 years at Screening.
4. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight or looped HAV in either the forearm or upper arm.
5. Hemoglobin ≥8 g/dL and platelet count ≥100,000 /mm3.
6. International Normalized Ratio (INR) ≤ 1.5.
7. Female subjects must be either:
1. Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).
2. Or, of childbearing potential, in which case:
i. Must have a negative urine or serum pregnancy test at Screening, and ii. Must agree to use at least one form of the following birth control methods for the duration of the study:
* Established use of oral, injectable or implanted hormonal methods of contraception.
* Placement of an intrauterine device or intrauterine system.
* Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.
8. 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.
9. Life expectancy of at least 2 years.
Exclusion Criteria
1. No previous failed AVF.
2. Cephalic vein diameter on ultrasound of more than 3.5mm.
3. Radial artery diameter on ultrasound of more than 3mm.
4. Vein depth of less than 0.5cm from the skin.
5. Normal Allen's test indicating that ulnar artery flow to the hand is sufficient.
6. No calcification in the wall of the distal radial artery.
7. Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment.
8. No evidence of iatrogenic injury to target artery or vein.
2. Uncontrolled diabetes;
a. HbA1c \>10% (at Screening).
3. History or evidence of severe peripheral arterial disease in the extremity selected for implant.
4. Known or suspected central vein stenosis or obstruction on the side of planned SA creation, unless corrected prior to randomization.
5. Planned AVF creation that requires more than one stage to complete. (e.g. basilic vein transposition AVF performed in 2 stages).
6. Planned AVF creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices).
7. Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product.
8. Cancer that is actively being treated with a cytotoxic agent.
9. Documented hyper-coagulable state.
10. Bleeding diathesis.
11. Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
1. Low dose glucocorticoid therapy (e.g. 5-10mg prednisone \[Deltason\]) is acceptable.
2. High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
3. Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded.
4. The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
* tacrolimus or FK506 \[Prograf\]
* mycophenolate mofetil \[Cellcept\],
* cyclosporine \[Sandimmune or Gengraf\]
* sirolimus \[Rapamune\] (this only includes systemically administered, drug eluting stents are acceptable)
12. Anticipated renal transplant within 6 months.
13. History of heparin-induced thrombocytopenia.
14. Venous outflow from SA cannot be located more centrally than the venous outflow of any previous failed access in that extremity.
15. 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 SA creation.
16. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.
17. Pregnant women, or women intending to become pregnant during the course of the trial.
18. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA.
19. Previous enrollment in this study or any other study with HAV.
20. Employees of Humacyte and employees or relatives of an investigator.
18 Years
ALL
No
Sponsors
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CTI Clinical Trial and Consulting Services
OTHER
California Institute for Regenerative Medicine (CIRM)
OTHER
Humacyte, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shamik Parikh, MD
Role: STUDY_DIRECTOR
Humacyte, Inc.
Locations
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Arizona Kidney Disease and Hypertension Center (AKDHC)
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
University of California, Irvine
Irvine, California, United States
University of California San Diego, Jacobs Medical Center
La Jolla, California, United States
University of CA, San Diego - LaJolla VA Hospital
La Jolla, California, United States
Alliance Research
Laguna Hills, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
University of Southern California
Los Angeles, California, United States
Huntington Hospital
Pasadena, California, United States
UC Davis
Sacramento, California, United States
Balboa Nephrology
San Diego, California, United States
Mills Peninsula Hospital
San Mateo, California, United States
Olive View- UCLA Medical Center
Sylmar, California, United States
Denver Health Medical Center
Denver, Colorado, United States
The Vascular Experts
Darien, Connecticut, United States
Memorial Healthcare System
Pembroke Pines, Florida, United States
Coastal Vascular & Interventional, PLLC
Pensacola, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
United Surgical Associates
Lexington, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Kidney Care & Transplant Services of New England
West Springfield, Massachusetts, United States
Rutgers University
Newark, New Jersey, United States
Overlook Medical Center
Summit, New Jersey, United States
Surgical Specialists of Charlotte
Charlotte, North Carolina, United States
Kaiser Permanente Sunnsyide
Portland, Oregon, United States
VA Pittsburgh
Pittsburgh, Pennsylvania, United States
The Regional Medical Center
Orangeburg, South Carolina, United States
University of Tennessee Knoxville
Knoxville, Tennessee, United States
South Plains Surgery Center
Lubbock, Texas, United States
Countries
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Other Identifiers
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CLN-PRO-V007
Identifier Type: -
Identifier Source: org_study_id
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