To Compare the Efficacy and Safety of the HAV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

End Stage Renal Disease (ESRD) Clinical Trial

— HUMAXX  

Official title:

A Phase 3 Randomized Study to Compare the Efficacy and Safety of the Humacyte Human Acellular Vessel (HAV) With That of an Autogenous Arteriovenous Fistula (AVF) in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908084
• Other study ID #: CLN-PRO-V012
• Status: Recruiting
• Phase: Phase 3
• Start date: September 7, 2023
• Est. completion date: October 2027

Study information

• Verified date: April 2024
• Source: Humacyte, Inc.
• Contact: Jordanna Foster
• Phone: 9193139633
• Email: jfoster[@]humacyte.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the number of catheter-free days (CFD) and the rate and severity of any dialysis access-related infections between the HAV and AVF groups over 12 months in patients with end-stage renal disease (ESRD) needing hemodialysis (HD). Participants will be stratified by location of the vascular access (forearm versus upper arm) and by type of AVF creation procedure planned by the surgeon at randomization (1-stage AVF versus 2-stage AVF). The comparator is an upper extremity arterio-venous fistula (AVF) for HD access surgically created per the institution's Standard of Care (SoC).

Description:

This is a prospective, multicenter, randomized, two-arm, comparative Phase 3 study of female patients with ESRD, who are receiving clinically successful hemodialysis (HD) via a central venous dialysis catheter (DC). Approximately 150 female patients will be randomized 1:1 to either the HAV or the AVF treatment arm. Patients will be stratified by location of the vascular access (forearm versus upper arm) and by type of AVF creation procedure planned by the surgeon at randomization (1-stage AVF versus 2-stage AVF). Patients who have a patent SA at Month 12 will then be followed in the Long-Term Extension study for an additional 12 months with evaluation of exploratory long-term endpoints.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2027
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Female patients with ESRD, currently receiving hemodialysis via dialysis catheter and who are candidates for the creation of an AVF (see Inclusion Criterion #4 below) or implantation of an HAV for HD access.

2. Patients who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least 12 months after SA creation.

3. Patients aged = 18 years at Screening.

4. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight, curved, or looped HAV in either the forearm or upper arm. NOTE: Suitable anatomy will be determined by both physical examination and ultrasound imaging or vessel imaging modality in addition to consideration of all vascular sites available, prior access failure, future access sites and possibilities to preserve patients' future alternate accesses. Vessel mapping is the preferred method to assess

the vascular anatomy, and will evaluate the following attributes during Screening:

• Vein diameter
• Arterial diameter
• Presence of arterial calcification
• Depth of the intended fistula conduit from the surface of the skin
• Central vein patency
• Previous vascular access location The ultimate decision of anatomic suitability belongs to the surgeon and/or the investigator.

5. Hemoglobin = 7 g/dL and platelet count = 100,000 /mm3

6. Patients must either:

1. Be of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile (i.e., total hysterectomy or tubal ligation, or complete bilateral oophorectomy) at least 1 month prior to Screening.

2. Or, if of childbearing potential:

Must have a negative serum pregnancy test at Screening, and Must agree to use at least one form of the following birth control methods for the duration of the study: i. Established use of oral, injectable or implanted hormonal methods of contraception. ii. Placement of an intrauterine device or intrauterine system at least 5 days prior to Screening. iii. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository.

7. Patient or their legal representative can communicate effectively with investigative staff, is competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits.

8. Life expectancy of at least 1 year confirmed by Charlson Comorbidity Index = 8.

Exclusion Criteria:

1. Male sex at birth.

2. Planned AVF creation by means other than suture or vascular anastomotic clips (e.g., endovascular surgery or other anastomotic creation devices). Venous outflow from study access cannot be located more distally than the venous outflow of any previous failed access in that extremity.

3. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy.

4. Pregnancy, or women intending to become pregnant during the course of the trial.

5. Treatment with any investigational drug or device within 60 days or 5 half-lives after taking the last dose (whichever is longer) prior to study entry (Day 1) or ongoing participation in a clinical trial of an investigational product.

6. Documented hyper-coagulable state, as defined as either:

1. Documented hyper-coagulable state, as defined as either: A biochemical diagnosis (e.g., Factor V Leiden, Protein C deficiency, etc.) - OR -

2. A clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g., deep vein thrombosis (DVT), pulmonary embolism (PE), etc.) within the previous 5 years.

7. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g., von Willebrand's disease, etc.).

8. Cancer actively being treated with a cytotoxic agent.

9. Planned or anticipated renal transplant within 6 months after randomization.

10. Any other condition that in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA.

11. Previous exposure to HAV.

12. Any of the following within 8 weeks prior to screening: acute coronary syndrome, stroke or congestive heart failure NYHA Stage IV

13. Employees of Humacyte and employees or relatives of an investigator.

Related Conditions & MeSH terms

• End Stage Renal Disease (ESRD)
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Biological:
• HAV
HAV implantation

Other:
• AVF
AVF creation procedure

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Georgia Nephrology	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	John Hopkins Bayview Medical Center	Baltimore	Maryland
United States	IU Health Bloomington Hospital	Bloomington	Indiana
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Surgical Specialists of Charlotte	Charlotte	North Carolina
United States	Ernest E. Moore Shock Trauma Center at Denver Health	Denver	Colorado
United States	New York-Presbyterian Queens_The Lang Center for Research & Education	Flushing	New York
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Dr. Ruben Villa__Nephrology	Lubbock	Texas
United States	Rutgers University_Medical	Newark	New Jersey
United States	St.Joseph's University Medical Center	Paterson	New Jersey
United States	Capital Health Medical Center- Hopewell	Pennington	New Jersey
United States	San Antonio Vascular and Endovascular Clinic PLLC	San Antonio	Texas
United States	Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Humacyte, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence rate of HD access-related interventions	Incidence rate of HD access-related interventions over the period from randomization until SA abandonment, or a defined timepoint after randomization (e.g., 12 months).	12 months
Other	The number of days from randomization to first day of functional dialysis	To determine the number of days from randomization to the first day of functional dialysis using the SA.	12 months
Other	Incidence rate of Study Access (SA) abandonment	To determine the incidence rate of SA abandonment.	12 months
Other	Health-related quality of life (HRQoL) of patients (a scale from 0 to 45, with higher scores meaning best outcome)	Health-related quality of life (HRQoL) of patients using the PROMIS-10 Questionnaire, a scale from 0 to 45, where the higher scores mean the best outcome.	12 months
Other	Vascular Access Questionnaire (VAQ) score (range 0-68 with higher scores mean worst outcome).	Vascular Access Questionnaire (VAQ) Questionnaire.; The Vascular Access Questionnaire (VAQ) is a patient reported outcome instrument containing 17 items pertaining to the impact of 17 access-related problems. Responses to the questionnaire are summed to produce a total VAQ score (range from 0-68) with higher values indicating more negative views of vascular access.	12 months
Other	The incidence rate of aneurysm or pseudoaneurysm	To determine the incidence rate of clinically significant aneurysm or pseudoaneurysm of the SA over the period from SA creation to 12 months.	12 months
Other	The incidence rate of adverse events (AEs)	To determine the incidence rate of adverse events (AEs) from SA creation to 12 months.	12 months
Primary	The number of catheter-free days since randomization to Month 12.	To determine the number of days free from indwelling catheter (catheter-free days) since randomization to 365 days (Month 12), or until SA abandonment, whichever occurs first.	12 months
Primary	The rate of infections related to any HD access.	To determine the rate of infections, related to any HD access over the period from SA creation (Day 1) until 12 months (365 days) after SA placement, without regard to SA abandonment.	12 months
Secondary	The number of catheter-free days since randomization to Month 6.	To determine the number of days free from indwelling catheter (catheter-free days) from randomization to 183 days (Month 6), or until SA abandonment, whichever occurs first.	6 months
Secondary	The number of days of the study access (SA) functional patency	To determine the number of days of Duration of functional patency of the SA over 12 months from randomization.	12 months
Secondary	The rate of the study access (SA) secondary patency	To determine the rate of the SA secondary patency at 6 and 12 months from randomization.	6 - 12 months
Secondary	The number of days from the study access (SA) maturation to abandonment	To determine the number of days from the study access (SA) maturation to abandonment.	12 months
Secondary	The rate of complications related to any HD access after the study access (SA) creation.	To determine the rate of complications related to any HD access during the 12 months after SA creation, without regard to SA abandonment. For the purposes of this endpoint, HD access refers to any surgically created access or device to provide a route for HD after randomization (e.g., SA, new AVF or AVG, or catheter).	12 months