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

Primary Purpose

End Stage Renal Disease (ESRD)

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HAV
AVF
Sponsored by
Humacyte, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease (ESRD) focused on measuring hemodialysis (HD), dialysis catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Patients who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least 12 months after SA creation. Patients aged ≥ 18 years at Screening. 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. Hemoglobin ≥ 7 g/dL and platelet count ≥ 100,000 /mm3 Patients must either: 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. 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. 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. Life expectancy of at least 1 year confirmed by Charlson Comorbidity Index ≤ 8. Exclusion Criteria: Male sex at birth. 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. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy. Pregnancy, or women intending to become pregnant during the course of the trial. 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. Documented hyper-coagulable state, as defined as either: 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 (DVT), pulmonary embolism (PE), etc.) within the previous 5 years. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g., von Willebrand's disease, etc.). Cancer actively being treated with a cytotoxic agent. Planned or anticipated renal transplant within 6 months after randomization. Any other condition that in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA. Previous exposure to HAV. Any of the following within 8 weeks prior to screening: acute coronary syndrome, stroke or congestive heart failure NYHA Stage IV Employees of Humacyte and employees or relatives of an investigator.

Sites / Locations

  • Grady Memorial HospitalRecruiting
  • Georgia NephrologyRecruiting
  • IU Health Bloomington HospitalRecruiting
  • Brigham and Women's HospitalRecruiting
  • St.Joseph's University Medical CenterRecruiting
  • New York-Presbyterian QueensRecruiting
  • Surgical Specialists of CharlotteRecruiting
  • Wake Forest University School of MedicineRecruiting
  • University of Tennessee Medical CenterRecruiting
  • Dr. Ruben Dr. Villa NephrologyRecruiting
  • San Antonio Vascular and Endovascular Clinic PLLCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HAV treatment arm

AVF treatment arm

Arm Description

HAV will be implanted as an arterio-venous (AV) access into the forearm or upper arm

AVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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).

Full Information

First Posted
April 28, 2023
Last Updated
October 17, 2023
Sponsor
Humacyte, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05908084
Brief Title
To Compare the Efficacy and Safety of the HAV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
October 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humacyte, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease (ESRD)
Keywords
hemodialysis (HD), dialysis catheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized 1:1 to either the HAV or the AVF treatment arm.
Masking
Outcomes Assessor
Masking Description
the study team at each site, including the surgeon performing the AVF creation or HAV implantation, the operating room staff, the dispensing pharmacist, and the Principal Investigator will be unblinded to treatment allocation. Members of the Data Monitoring Committee and the Clinical Evaluation Committee, as well as members of the CRO staff may be unblinded to treatment assignment to perform their functions. All Sponsor staff, with exception of Medical Monitor, Safety Scientist, and the HAV Inventory Supply and Tracking group, will remain blinded to treatment allocation while the study is in progress.
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HAV treatment arm
Arm Type
Experimental
Arm Description
HAV will be implanted as an arterio-venous (AV) access into the forearm or upper arm
Arm Title
AVF treatment arm
Arm Type
Active Comparator
Arm Description
AVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm
Intervention Type
Biological
Intervention Name(s)
HAV
Intervention Description
HAV implantation
Intervention Type
Other
Intervention Name(s)
AVF
Intervention Description
AVF creation procedure
Primary Outcome Measure Information:
Title
The number of catheter-free days since randomization to Month 12.
Description
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.
Time Frame
12 months
Title
The rate of infections related to any HD access.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
The number of catheter-free days since randomization to Month 6.
Description
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.
Time Frame
6 months
Title
The number of days of the study access (SA) functional patency
Description
To determine the number of days of Duration of functional patency of the SA over 12 months from randomization.
Time Frame
12 months
Title
The rate of the study access (SA) secondary patency
Description
To determine the rate of the SA secondary patency at 6 and 12 months from randomization.
Time Frame
6 - 12 months
Title
The number of days from the study access (SA) maturation to abandonment
Description
To determine the number of days from the study access (SA) maturation to abandonment.
Time Frame
12 months
Title
The rate of complications related to any HD access after the study access (SA) creation.
Description
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).
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Incidence rate of HD access-related interventions
Description
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).
Time Frame
12 months
Title
The number of days from randomization to first day of functional dialysis
Description
To determine the number of days from randomization to the first day of functional dialysis using the SA.
Time Frame
12 months
Title
Incidence rate of Study Access (SA) abandonment
Description
To determine the incidence rate of SA abandonment.
Time Frame
12 months
Title
Health-related quality of life (HRQoL) of patients (a scale from 0 to 45, with higher scores meaning best outcome)
Description
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.
Time Frame
12 months
Title
Vascular Access Questionnaire (VAQ) score (range 0-68 with higher scores mean worst outcome).
Description
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.
Time Frame
12 months
Title
The incidence rate of aneurysm or pseudoaneurysm
Description
To determine the incidence rate of clinically significant aneurysm or pseudoaneurysm of the SA over the period from SA creation to 12 months.
Time Frame
12 months
Title
The incidence rate of adverse events (AEs)
Description
To determine the incidence rate of adverse events (AEs) from SA creation to 12 months.
Time Frame
12 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Patients who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least 12 months after SA creation. Patients aged ≥ 18 years at Screening. 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. Hemoglobin ≥ 7 g/dL and platelet count ≥ 100,000 /mm3 Patients must either: 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. 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. 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. Life expectancy of at least 1 year confirmed by Charlson Comorbidity Index ≤ 8. Exclusion Criteria: Male sex at birth. 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. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy. Pregnancy, or women intending to become pregnant during the course of the trial. 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. Documented hyper-coagulable state, as defined as either: 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 (DVT), pulmonary embolism (PE), etc.) within the previous 5 years. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g., von Willebrand's disease, etc.). Cancer actively being treated with a cytotoxic agent. Planned or anticipated renal transplant within 6 months after randomization. Any other condition that in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA. Previous exposure to HAV. Any of the following within 8 weeks prior to screening: acute coronary syndrome, stroke or congestive heart failure NYHA Stage IV Employees of Humacyte and employees or relatives of an investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordanna Foster
Phone
9193139633
Email
jfoster@humacyte.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Taylor
Phone
919.313.9633
Ext
185
Email
etaylor@humacyte.com
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgia Nephrology
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Individual Site Status
Recruiting
Facility Name
IU Health Bloomington Hospital
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47408
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
St.Joseph's University Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Individual Site Status
Recruiting
Facility Name
New York-Presbyterian Queens
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Recruiting
Facility Name
Surgical Specialists of Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Ruben Dr. Villa Nephrology
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79407
Country
United States
Individual Site Status
Recruiting
Facility Name
San Antonio Vascular and Endovascular Clinic PLLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78221
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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