Comparison of Humacyte's Human Acellular Vessel with ePTFE Grafts for Hemodialysis Access

Phase 1

Conditions: End-stage renal disease (ESRD) requiring placement of an arteriovenous (AV) graft in the arm (upper- or forearm) to start or maintain hemodialysis therapy.
MedDRA version: 20.0Level: SOCClassification code 10042613Term: Surgical and medical proceduresSystem Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 20.1Level: LLTClassification code 10066772Term: Vascular access operationSystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2015-003261-28-GB

Lead Sponsor: Humacyte, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 350

Inclusion Criteria

1. Subjects with ESRD who are not, or who are no longer candidates for creation of an autologous AV fistula and therefore need placement of an AV graft in the arm (upper- or forearm) to start or maintain hemodialysis therapy.
2. Either on hemodialysis or expected to start hemodialysis within 12 weeks of conduit formation.
3. At least 18 years of age at Screening.
4. Suitable anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow).
5. Hemoglobin =8 g/dL and platelet count =100,000 cells/mm3 prior to Day 0 (within 35 days).
6. Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 35 days).
7. Adequate liver function prior to Day 0 (within 35 days), defined as both of the following:
a. =2x upper limit of normal (ULN) for serum bilirubin, aspartate transaminase (AST), and alanine transaminase (ALT)
b. =1.5 for International Normalized Ratio (INR) or prothrombin time (PT) = 18 seconds unless the subject is taking an anticoagulant at the time
8. Female subjects must be either:
a. 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)
b. Or, of childbearing potential, in which case:
i. Must have a negative serum or urine 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:
1. Established use of oral, injectable or implanted hormonal methods of contraception
2. Placement of an intrauterine device or intrauterine system
3. Barrier methods of contraception:
condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository
9. 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.
10. Life expectancy of at least 1 year.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. History or evidence of severe peripheral vascular disease in the intended arm for implantation.
2. Known or suspected central vein stenosis or conduit occlusion on the ipsilateral side of the planned implantation, unless the stenosis is corrected prior to study conduit implantation.
3. 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.
4. Cancer that is actively being treated with a cytotoxic agent.
5. Documented hyper-coagulable state.
6. Bleeding diathesis.
7. Active clinically significant immune mediated disease, not controlled by maintenance immunosuppression.
a. Low dose glucocorticoid therapy (e.g. up to 10mg a day prednisone or prednisolone) is acceptable.
b. High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded.
c. Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post
allograft failure are excluded.
d. The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial:
i. tacrolimus or FK506 [Prograf]
ii. mycophenolate mofetil [Cellcept],
iii. cyclosporine [Sandimmune or Gengraf]
iv. Sirolimus administered systemically (Sirolimus in drug eluting stents is NOT an exclusion)
8. Anticipated renal transplant within 6 months.
9. Venous outflow from study conduit cannot be placed more centrally than the venous outflow of any previous failed access in that extremity.
10. 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.
11. Known serious allergy to planned antiplatelet agent.
12. Pregnant women, or women intending to become pregnant during the course of the trial.
13. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the study conduit.
14. Previous enrollment in this study or any other study with the HAV.
15. Employees of Humacyte and employees or relatives of the investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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