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Procedure

HAV vs AVF for Kidney Failure (HUMAXX Trial)

Phase 3
Recruiting
Research Sponsored by Humacyte, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patients with ESRD, currently receiving hemodialysis via dialysis catheter and who are candidates for the creation of an AVF or implantation of an HAV for HD access
Patients aged ≥ 18 years at Screening
Must not have
Male sex at birth
Treatment with any investigational drug or device within 60 days or 5 half-lives after taking the last dose prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 - 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial compares the success of two methods of dialysis access for patients with kidney failure.

Who is the study for?
This trial is for female patients with end-stage renal disease who are on hemodialysis. They must be non-childbearing or using birth control, able to consent and follow study procedures, aged 18+, planning to undergo dialysis at a participating provider for at least 12 months, have suitable anatomy for AVF or HAV implantation, and a life expectancy of at least one year.
What is being tested?
The trial compares the efficacy and safety of two types of vascular access for hemodialysis: the Hemodialysis Access via Vein (HAV) versus the standard Arterio-Venous Fistula (AVF). It measures catheter-free days and infection rates over a year in women stratified by arm location and type of AVF procedure.
What are the potential side effects?
Potential side effects may include complications related to surgery such as infection, clotting issues around the access site, bleeding disorders due to antiplatelet therapy intolerance or allergies. Specific side effects will depend on individual patient responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman with end-stage renal disease on hemodialysis needing a new access for dialysis.
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I am 18 years old or older.
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My arm's structure allows for a specific type of vascular access creation.
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I plan to have hemodialysis at a participating provider for at least a year after creating a surgical access.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was assigned male at birth.
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I haven't taken any experimental drugs or used experimental devices in the last 60 days.
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I am scheduled for a fistula creation without using sutures or clips.
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I am currently receiving chemotherapy for my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 - 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 - 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The number of catheter-free days since randomization to Month 12.
The rate of infections related to any HD access.
Secondary study objectives
The number of catheter-free days since randomization to Month 6.
The number of days from the study access (SA) maturation to abandonment
The number of days of the study access (SA) functional patency
+2 more
Other study objectives
Health-related quality of life (HRQoL) of patients (a scale from 0 to 45, with higher scores meaning best outcome)
Incidence rate of HD access-related interventions
Incidence rate of Study Access (SA) abandonment
+4 more

Side effects data

From 2009 Phase 3 trial • 4545 Patients • NCT00474526
85%
INJECTION SITE PAIN
67%
INJECTION SITE ERYTHEMA
62%
SOMNOLENCE
58%
IRRITABILITY
51%
CRYING
41%
PYREXIA
40%
INJECTION SITE INDURATION
35%
DIARRHOEA
32%
EATING DISORDERS
28%
VOMITING
23%
NASOPHARYNGITIS
17%
RASH
12%
BRONCHITIS
9%
RESPIRATORY TRACT INFECTION
9%
MALAISE
6%
BRONCHIOLITIS
4%
GASTROOESOPHAGEAL REFLUX DISEASE
4%
GASTROENTERITIS
3%
CONJUNCTIVITIS
3%
VIRAL INFECTION
3%
COUGH
2%
OTITIS MEDIA
2%
OTITIS MEDIA ACUTE
2%
DERMATITIS ATOPIC
1%
PNEUMONIA
1%
URINARY TRACT INFECTION
1%
BRONCHOSPASM
1%
BACTERIAL DIARRHOEA
100%
80%
60%
40%
20%
0%
Study treatment Arm
LA2+4+6AB
US1+US3
US2+US4A+US4B
US4C
LA6C
LA1+LA3+LA5

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HAV treatment armExperimental Treatment1 Intervention
HAV will be implanted as an arterio-venous (AV) access into the forearm or upper arm
Group II: AVF treatment armActive Control1 Intervention
AVF creation procedure (1-stage AVF or 2-stage AVF) as an arterio-venous (AV) access into the forearm or upper arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HAV
2007
Completed Phase 3
~4580

Find a Location

Who is running the clinical trial?

Humacyte, Inc.Lead Sponsor
10 Previous Clinical Trials
809 Total Patients Enrolled
~87 spots leftby Oct 2026
Unbiased ResultsWe believe in providing patients with all the options.
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