HAV vs AVF for Kidney Failure

(HUMAXX Trial)

Recruiting at 37 trial locations

Overseen By Elizabeth Taylor

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Humacyte, Inc.

Must not be taking: Aspirin, Antiplatelet therapy, others

Disqualifiers: Male, Pregnancy, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which treatment is better for people with end-stage kidney disease needing dialysis: a new bioengineered blood vessel (HAV) or the usual method using a connection made with the body's own blood vessels (AVF). Researchers will examine how long patients can avoid using a catheter and how often they experience infections related to their dialysis access over 12 months. Women with kidney failure who are already on dialysis and use a catheter might be suitable candidates, especially if they are considering a new way to connect to dialysis. Participants will receive either the HAV or AVF treatment and will be monitored to assess which is more effective and safer. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial staff or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that the Human Acellular Vessel (HAV) used in this trial is generally well-tolerated by patients with advanced kidney disease. Research indicates that serious side effects are rare, and most issues are mild, suggesting the treatment is safe for people. Most patients do not experience severe problems, and the treatment effectively creates access for dialysis. While no treatment is without risk, existing evidence supports the safety of HAV in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for kidney failure, which typically involves creating an arteriovenous fistula (AVF) for dialysis access, the investigational treatment called Human Acellular Vessel (HAV) is a bioengineered blood vessel. Researchers are excited about HAV because it is designed to integrate with the patient's tissue, potentially reducing the risk of infection and the need for repeat surgeries. Additionally, HAV can be produced in a consistent quality and size, which might offer a more reliable and quicker solution compared to traditional AVF procedures that depend on the patient's own vein quality.

What evidence suggests that this trial's treatments could be effective for kidney failure?

This trial will compare the Human Acellular Vessel (HAV) with the Arteriovenous Fistula (AVF) for creating dialysis access in patients with end-stage kidney disease. Research has shown that HAV could be a promising new option, as early studies successfully used it in complex surgeries, indicating it can reliably help blood flow. The HAV is designed to resist infections and blockages, common problems with traditional methods. Patients who used HAV experienced positive results, including fewer complications compared to traditional methods. Overall, evidence suggests that HAV could improve the quality of life for those needing regular dialysis by providing a more stable and durable access point. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a woman with end-stage renal disease on hemodialysis needing a new access for dialysis.

You are expected to live for at least 1 year based on your overall health condition.

My arm's structure allows for a specific type of vascular access creation.

Exclusion Criteria

You have had previous exposure to hepatitis A virus.

I am scheduled for a kidney transplant within the next 6 months.

I haven't had a severe heart attack, stroke, or heart failure in the last 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the ATEV or AVF treatment for hemodialysis access

12 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-Term Extension

Participants with patent SA at Month 12 are followed for an additional 12 months to evaluate long-term endpoints

12 months

What Are the Treatments Tested in This Trial?

Interventions

• AVF
• HAV

Trial Overview 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.

How Is the Trial Designed?

Group I: ATEV treatment arm Experimental Treatment 1 Intervention

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

Group II: AVF treatment arm Active Control 1 Intervention

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

AVF is already approved in United States, European Union for the following indications:

Approved in United States as Arteriovenous Fistula for:

• Hemodialysis access for end-stage renal disease

Approved in European Union as Arteriovenous Fistula for:

• Hemodialysis access for end-stage renal disease

Who Is Running the Clinical Trial?

Humacyte, Inc.

Lead Sponsor

Trials

11

Recruited

960+

IQVIA Biotech

Industry Sponsor

Trials

22

Recruited

5,900+

Published Research Related to This Trial

In a study of 174 maintenance hemodialysis patients over one year, the autogenous arteriovenous fistula (AVF) was the most commonly used vascular access, showing a favorable one-year patency rate of 63.2%.

Despite the overall positive outcomes, complications occurred in 27.3% of patients, with AVF failure being the most common issue, highlighting the need for careful monitoring and management of vascular access in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome and complications of permanent hemodialysis vascular access in Nigerians: a single centre experience. Alhassan, SU., Adamu, B., Abdu, A., et al.[2013]

In a study of 464,547 patients starting hemodialysis, the use of arteriovenous fistula (AVF) for first hemodialysis varied significantly by region, ranging from 11.1% to 22.2%, which is crucial since AVF access is linked to improved survival in end-stage renal disease (ESRD) patients.

The analysis revealed a 28% variation in mortality hazard rates across different regions, indicating that better access to nephrology care can significantly increase the likelihood of starting hemodialysis with an AVF, highlighting the need for improved adherence to best-practice guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Improvement Targets for Regional Variation in Surgical End-Stage Renal Disease Care. Zarkowsky, DS., Hicks, CW., Arhuidese, I., et al.[2022]

In a study of 205 patients undergoing hemodialysis, the use of hemodialysis catheters (KT) was primarily for waiting on arteriovenous fistula (AVF) creation, with a notable 39.2% infection rate linked to prolonged use and low hemoglobin levels, although antiseptic locks significantly reduced infection risk.

The study found that AVF complications, such as thrombosis and aneurysm, were common, with diabetes and obesity being significant risk factors; however, antiplatelet therapy was shown to improve AVF patency, highlighting the need for timely AVF creation and better management of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolutive profile of hemodialysis vascular accesses Hemodialysis accesses. Gorsane, I., Chermiti, M., Mechri, E., et al.[2022]

In a study involving 48 patients, the saphenofemoral arteriovenous fistula (SFAVF) showed a primary patency rate of 44% after 59 months, indicating it can be a viable long-term access option for hemodialysis.

Despite some complications, including thrombosis in 39% of cases, the SFAVF demonstrated a low overall complication rate and effective dialysis for patients lacking other upper limb access options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saphenofemoral arteriovenous fistula as hemodialysis access. Correa, JA., de Abreu, LC., Pires, AC., et al.[2021]

In a study of 532 hemodialysis patients followed for a median of 28 months, those using arteriovenous fistulas (AVF) had significantly lower mortality rates compared to those using central venous catheters (CVC), with a hazard ratio of 1.58 after adjustments for other factors.

The research identified that older age, female gender, and higher comorbidity scores were associated with a higher likelihood of using non-AVF access methods, highlighting the importance of promoting AVF use to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hemodialysis vascular access and clinical outcomes: an observational multicenter study. Soleymanian, T., Sheikh, V., Tareh, F., et al.[2017]

In a study of 9,291 kidney transplant patients, the type of vascular access used during hemodialysis (AVF, AVG, or CVC) did not show a significant association with all-cause mortality or overall allograft loss after transplantation.

However, patients who used central venous catheters (CVC) had a 30% higher risk of allograft loss from causes other than death compared to those who used arteriovenous fistulas (AVF), indicating that CVCs may pose a greater risk for certain complications post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Type of Vascular Access Used in Hemodialysis Patients and Subsequent Kidney Transplant Outcomes. Airy, M., Lenihan, CR., Ding, VY., et al.[2023]

In a study of 536 hemodialysis patients, 47% experienced failure of their autologous arteriovenous fistula (AVF) within 12 months, highlighting a significant challenge in vascular access for dialysis.

Factors linked to higher AVF failure rates included being female, having lower diastolic blood pressure, using a central venous catheter, and requiring aspirin therapy, suggesting these could inform better vascular access planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Arteriovenous Fistula Failure: A Post Hoc Analysis of the FAVOURED Study. See, YP., Cho, Y., Pascoe, EM., et al.[2022]

The use of human acellular vessels (HAV) as a conduit for vascular access in hemodialysis shows promise in improving safety and efficacy for patients with end-stage renal disease, particularly in complex cases where standard options are limited.

In a high-risk population with significant comorbidities, the technical success of surgeries using HAV for aneurysm repairs suggests that this regenerative medicine approach could expand treatment options for patients needing vascular access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair. Nickerson, MC., Thamba, A., Rao, V., et al.[2023]

In a study of 2200 patients, arteriovenous fistulas (AVF) showed better survival benefits and vascular access (VA) patency compared to arteriovenous grafts (AVG) in patients under 80 years old, particularly in those aged 70-79.

For patients aged 80 and older, both AVF and AVG demonstrated similar patency rates, indicating that the advantages of AVF may diminish in this older age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of vascular access patency and patient survival between native arteriovenous fistula and synthetic arteriovenous graft according to age group. Choi, J., Ban, TH., Choi, BS., et al.[2021]

In elderly patients starting hemodialysis, creating an arteriovenous fistula (AVF) leads to greater initial catheter dependence compared to an arteriovenous graft (AVG), with 95.6% of AVF patients dependent on catheters at 1 month versus 92.5% for AVG patients.

However, over a longer period (up to 36 months), AVF patients showed lower long-term catheter dependence, with only 8.2% remaining catheter-dependent compared to 15.0% for AVG patients, indicating that while AVFs may require more initial catheter use, they offer better long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter Dependence After Arteriovenous Fistula or Graft Placement Among Elderly Patients on Hemodialysis. Lyu, B., Chan, MR., Yevzlin, AS., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03183245

Study Details | NCT03183245 | Comparison of the Human ... The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. It will be surgically implanted ...

2. withpower.com withpower.com/trial/phase-3-kidney-diseases-6-2023-9a7ed

HAV vs AVF for Kidney Failure (HUMAXX Trial) The Human Acellular Vessel (HAV) has been used in complex vascular surgeries, including for patients with end-stage renal disease, under the FDA's Expanded ...

3. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/december_18_2024_clinical_review_memo_-_symvess.pdf

Clinical Review Memo - SYMVESS from clinical studies conducted in patients with end-stage renal disease (ESRD), peripheral artery disease (PAD) in addition to vascular trauma ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8108319/

Challenges and novel therapies for vascular access in ... The HAV has been evaluated in phase II trials in patients with kidney failure ... outcomes in incident end-stage renal disease patients. Am. J. Nephrol 48 ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05908084?term=AREA%5BExpandedAccessNCTId%5DNCT03631056&rank=1

Study Details | NCT05908084 | To Compare the Efficacy ... To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis. ClinicalTrials.gov ID ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03183245

Study Details | NCT03183245 | Comparison of the Human ... The HAV is a tissue-engineered vascular conduit (6mm diameter) for hemodialysis access in patients with end-stage renal disease. It will be surgically implanted ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04135417

Safety and Efficacy Assessment of HAV in Patients ... 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4915925/

Bioengineered human acellular vessels for dialysis access in ... The prevalence of comorbid diseases was similar in the Polish cohort and the United States Renal Data System for patients with end-stage renal disease, ...

9. investors.humacyte.com investors.humacyte.com/news-releases/news-release-details/humacyte-present-efficacy-and-safety-results-v007-phase-3-av

Press Release Details ... Safety Results from V007 Phase 3 AV Access Clinical Trial ... Vessel with Autologous AV Fistulas in Patients with End Stage Renal Disease.