HAV vs AVF for Kidney Failure

(HUMAXX Trial)

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Humacyte, Inc.

Must not be taking: Aspirin, Antiplatelet therapy, others

Disqualifiers: Male, Pregnancy, Cancer, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 ATEV 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).

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.

What data supports the effectiveness of the treatment HAV and AVF for kidney failure?

Research shows that arteriovenous fistulas (AVF) are preferred for hemodialysis because they have fewer complications and last longer compared to other methods like arteriovenous grafts (AVG) and central venous catheters (CVC). This suggests that AVF is an effective treatment option for patients with kidney failure. ^{1 2 3 4 5}

Is the Human Acellular Vessel (HAV) safe for use in humans?

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 Access Program. In these high-risk cases, the HAV showed potential for safe use, offering technical success in surgeries and addressing unmet medical needs. ^{2 4 6 7 8}

How is the HAV treatment different from other treatments for kidney failure?

The Human Acellular Vessel (HAV) is a novel treatment for kidney failure that offers an alternative to traditional arteriovenous fistulas (AVF) by using a bioengineered vessel, which may provide better outcomes for patients with poor vessel quality, such as the elderly. Unlike synthetic grafts, HAVs are designed to integrate with the patient's tissue, potentially reducing complications and improving long-term access survival. ^{2 4 6 9 10}

Research Team

Eligibility Criteria

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.

I am 18 years old or older.

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

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.

Trial Timeline

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

Treatment Details

Interventions

• AVF (Procedure)
• HAV (Procedure)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

Humacyte, Inc.

Lead Sponsor

Trials

11

Recruited

960+

IQVIA Biotech

Industry Sponsor

Trials

22

Recruited

5,900+

Findings from Research

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 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]

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 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 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 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 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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Hemodialysis vascular access and clinical outcomes: an observational multicenter study. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Catheter Dependence After Arteriovenous Fistula or Graft Placement Among Elderly Patients on Hemodialysis. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Association Between Type of Vascular Access Used in Hemodialysis Patients and Subsequent Kidney Transplant Outcomes. [2023]

4. Canada 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. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Quality Improvement Targets for Regional Variation in Surgical End-Stage Renal Disease Care. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Outcome and complications of permanent hemodialysis vascular access in Nigerians: a single centre experience. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Predictors of Arteriovenous Fistula Failure: A Post Hoc Analysis of the FAVOURED Study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair. [2023]

9. Tunisia pubmed.ncbi.nlm.nih.gov

Evolutive profile of hemodialysis vascular accesses Hemodialysis accesses. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Saphenofemoral arteriovenous fistula as hemodialysis access. [2021]