Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis

NCT04135417 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CLN-PRO-V011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase 2, prospective, multicenter, open-label, single-arm study of the Human Acellular Vessel (HAV).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Cumulative Number of Subjects With Adverse Events Indicating Possible Mechanical Failure or Weakness of the HAV

  Frequency and severity of AEs of each patient will be documented

  Up to 3 months post-implantation

• Number of Participants With Baseline Change of Panel Reactive Antibody (PRA) Value

  Assess changes in the PRA response (number of participants) over the 2 months after graft implantation

  2 months post implantation

• Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESI)

  Frequency and severity of all adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESI) of each patient will be documented.

  Up to 3 months post-implantation

• Number of Participants With Primary Patency, Primary Assisted Patency and Secondary Patency

  3 months post-implantation

Secondary Outcomes (2)

• Number of Participants With Baseline Change of Panel Reactive Antibody (PRA) Value

  12 months post-implantation

• Number of Participants With All AEs/SAEs

  Up to 12 months post-implantation

Study Arms (1)

HAV

EXPERIMENTAL

The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. HAV for this study will be manufactured using the commercial manufacturing system.It will be implanted in the forearm or upper arm using standard vascular surgical techniques. All subjects will be required to start taking daily aspirin (75 or 325 mg) on Day 1 after surgical implantation of HAV unless they are already taking another antiplatelet agent. If low molecular weight heparin (LMWH) is administered post-operatively, aspirin or other antiplatelet agents should be initiated after stopping LMWH. Subjects who are known to be aspirin-sensitive should take another antiplatelet agent at the discretion of the Principal Investigator.

Biological: HAV

Interventions

HAV BIOLOGICAL

Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.

HAV

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 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) for hemodialysis therapy.
• Already established on hemodialysis
• At least 18 years of age at Screening.
• Suitable arterial and venous 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 45 days).
• Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 45 days).
• Normal clotting (international normalized ration \[INR\] ≤ 1.5 or prothrombin time ≤ 18 sec unless the patient is taking an anticoagulant for an approved indication at the time of HAV implantation.
• Female subjects must be either:
• 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)
• 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:
• \. 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.
• \. 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 the planned implantation, unless the stenosis is corrected prior to HAV implantation.
• 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.
• Cancer that is actively being treated with a cytotoxic agent.
• Documented hyper-coagulable state as defined as either:
• a biochemical diagnosis (e.g. Factor V Leiden, Protein C deficiency, etc.) - OR -
• a clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g deep vein thrombosis, pulmonary embolism, etc.) within the 5 previous years.
• Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g. von Willebrand disease, etc.).
• Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression.
• Low dose glucocorticoid therapy (e.g. up to 10 mg a day prednisone or prednisolone) is acceptable.
• 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.
• Anticipated renal transplant within 6 months.
• Venous outflow from HAV cannot be placed more centrally than the venous outflow of any previous failed access on 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 1 week post resolution of that infection before implantation.

Sponsors & Collaborators

• Humacyte, Inc.: lead

Study Sites (2)

Szpital Kliniczny Przemienienia Pańskiego UM w Poznaniu, Klinika Chirurgii Ogólnej i Naczyń

Poznan, 61-848, Poland

Location

Wojewódzki Szpital Specjalistyczny we Wrocławiu, Oddział Chirurgii Naczyniowej

Wroclaw, 51-124, Poland

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Failure, Chronic

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

Results Point of Contact

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

sparikh@humacyte.com

919-313-9633

Study Officials

• Shamik Shamik, MD

  Humacyte, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 22, 2019
• Study Start: November 12, 2019
• Primary Completion: May 15, 2021
• Study Completion: March 2, 2022
• Last Updated: March 19, 2024
• Results First Posted: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)