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: 20.0 Level: SOC Classification code 10042613 Term: Surgical and medical procedures System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: LLT Classification code 10066772 Term: Vascular access operation System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Humacyte’s Human Acellular Vessel
Product Code: HAV
Pharmaceutical Form: Implant
Trade Name: Gore® PROPATEN® Vascular Graft
or
Bard® Impra® Vascular Graft
Product Name: Gore® PROPATEN®
Sponsors
Humacyte, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the Secondary Patency of the HAV with that of the ePTFE graft when used as a conduit for hemodialysis;Secondary Objective: Efficacy To compare the Primary Patency of the HAV with that of the ePTFE graft. Safety To compare the rate of access-related infections for the HAV with that of the ePTFE graft. Other Secondary Objectives: Efficacy 1. To compare the rate of interventions needed to maintain/restore patency of the HAV with that of the ePTFE graft. 2. To compare the Primary Assisted Patency of the HAV with that of the ePTFE graft. 3. To describe the histopathological remodeling of samples from HAV and ePTFE grafts. 4. To compare the efficiency of dialysis with the HAV with that of the ePTFE graft in a subset of subjects. Safety 1. To compare the safety and tolerability of the HAV with that of the ePTFE. 2. To compare the relative rates of true aneurysm and pseudoaneurysm formation.;Primary end point(s): Time to loss of Secondary Patency from implantation * Defined as ‘the interval from the time of access placement until access abandonment’, i.e., patent with or without interventions;Timepoint(s) of evaluation of this end point: Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy Time to loss of Primary Patency from implantation * Defined as ‘the interval from the time of access placement until any intervention designed to maintain or reestablish patency, access thrombosis or the measurement of patency’, i.e., patent without interventions Safety Access-related infections;Timepoint(s) of evaluation of this end point: Month 12 | — |
Countries
Germany, Israel, Poland, Portugal, United Kingdom, United States
Contacts
Public ContactHumacyte Clinical Development
Humacyte, Inc.
Outcome results
None listed