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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:1/20/2019
Start Date:September 29, 2017
End Date:December 2023
Contact:Angela Rose, MBA
Email:rose@humacyte.com
Phone:919-313-9633

Use our guide to learn which trials are right for you!

A Phase 3 Study to Compare the Efficacy and Safety of Humacyte's Human Acellular Vessel With That of an Autologous Arteriovenous Fistula in Subjects With End Stage Renal Disease

The main purpose of this study is to compare the Human Acellular Vessel (HAV) with
arteriovenous fistula (AVF) when used for hemodialysis access

This is a Phase 3, prospective, multicenter, open-label, randomized, two-arm, comparative
study. Subjects who sign informed consent will undergo study-specific screening assessments
within 45 days from the day of informed consent.

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.

Inclusion Criteria:

1. Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitable for
the creation of an AVF or implantation of AVG for HD access.

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. Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL
of the following 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.
We found this trial at
28
sites
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
?
mi
from
Boston, MA
Click here to add this to my saved trials
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
?
mi
from
Tampa, FL
Click here to add this to my saved trials
80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
1918 Randolph Road
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
?
mi
from
Decatur, IL
Click here to add this to my saved trials
777 Bannock St
Denver, Colorado 80204
(303) 436-6000
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
?
mi
from
Denver, CO
Click here to add this to my saved trials
Fresno, California 92123
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
?
mi
from
Irvine, CA
Click here to add this to my saved trials
Knoxville, Tennessee 37996
(865) 974-1000
University of Tennessee - Knoxville Founded in 1794, we're big on tradition and proud of...
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
3350 La Jolla Village Drive
La Jolla, California 92161
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Long Beach, California 90822
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90048
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Miami, Florida 33140
?
mi
from
Miami, FL
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
185 University Avenue
Newark, New Jersey 07103
?
mi
from
Newark, NJ
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Portland, Oregon 97015
?
mi
from
Portland, OR
Click here to add this to my saved trials
Sacramento, California 95817
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
7910 Frost Street
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
1635 Divisadero Street
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
San Mateo, California 94401
?
mi
from
San Mateo, CA
Click here to add this to my saved trials
Summit, New Jersey 07901
?
mi
from
Summit, NJ
Click here to add this to my saved trials
Sylmar, California 91342
?
mi
from
Sylmar, CA
Click here to add this to my saved trials
Tucson, Arizona 85721
(520) 621-2211
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials