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End-Stage Kidney DiseaseNCT04646226

The Arteriovenous Vascular (AV) ACCESS Trial

A study testing AV graft and surgical intervention for creation of a fistula in people with End-Stage Kidney Disease and Hemodialysis Complication, run by Wake Forest University Health Sciences at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
AV graft and surgical intervention for creation of a fistula
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
7 sitesUnited States
Study dates
18 Aug 2022to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 60 years or older
  • End-stage kidney disease on hemodialysis via a central venous catheter
  • Hemodialysis is the long-term modality of treatment for end-stage kidney disease
  • Central venous catheter is the sole vascular access used for hemodialysis at the time of referral for arteriovenous access creation
  • Referred by patient's nephrologist for placement of arteriovenous access
  • At least one of the following comorbid conditions: cardiovascular disease, peripheral vascular disease, and/or diabetes mellitus
Show all 9Show fewer
  • Medically and surgically eligible to undergo surgical placement of an arteriovenous access, deemed by the treating healthcare providers
  • Native vasculature deemed preoperatively to be suitable for surgical creation of either type of arteriovenous access (arteriovenous fistula or arteriovenous graft) in the opinion of the surgeon
  • Patient agreed to study participation and signed the informed consent

Who cannot join

  • Severe cardiac disease defined as presence of either of the following three conditions: congestive heart failure with ejection fraction ≤ 20%, heart transplant, or ventricular assist device
  • Known or suspected central vein stenosis or vascular obstruction on the side of planned study access creation, unless corrected prior to randomization
  • Planned arteriovenous fistula creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices)
  • Anticipated kidney transplant within 12 months
  • Anticipated conversion to peritoneal dialysis within 12 months
  • Anticipated transfer of nephrology care to a clinic outside the study participating centers within 12 months
  • Anticipated non-compliance with medical care based on physician judgment
  • A condition in which, in the opinion of the site PI renders the patient not a good candidate for study participation.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Johns Hopkins School of Medicine

    Baltimore, Maryland, 21205

  • University of Alabama at Birmingham School of Medicine

    Birmingham, Alabama, 35487

  • Prisma Health Upstate

    Greenville, South Carolina, 29601

  • University of Tennessee Medical Center at Knoxville

    Knoxville, Tennessee, 37920

  • UCLA

    Los Angeles, California, 90095

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53726

  • Atrium Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Randomized Trial of Fistula vs. Graft Arteriovenous Vascular Access in Older Adults With End-Stage Kidney Disease on Hemodialysis

This study is to prospectively compare the effectiveness and safety of the two types of arteriovenous access placement (fistula or graft) in older adults with end stage kidney disease and multiple chronic conditions

Read the detailed description

This study will determine the effects of arteriovenous (AV) fistula versus AV graft vascular access strategy on the rate of catheter-free dialysis days and access-related infections - costs associated with the dialysis vascular access - patient-reported satisfaction with different processes of vascular access care (catheter, fistula, or graft) - and the relationship between preoperative functional status and incidence of fistula or graft maturation failure

Being tested
AV graft, surgical intervention for creation of a fistula
Keywords
Hemodialysis, End-Stage Kidney Disease, central venous catheters, arteriovenous fistula [AVF], arteriovenous graft [AVG], Arteriovenous Vascular Access
Medical subject headings
Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AV graftDevice

    The purpose of the surgery is to connect a large vein in the arm to a nearby artery indirectly by inserting a graft material (graft surgery)

  • surgical intervention for creation of a fistulaProcedure or surgery

    The purpose of the surgery is to connect a large vein in the arm to a nearby artery directly (fistula surgery)

Study groups in NCT04646226
Study groupRoleWhat they receive
fistula surgically placedExperimentalRandomized group to have surgically placed fistula for permanent hemodialysis access
Receives: Procedure: surgical intervention for creation of a fistula
graft surgically placedActive comparatorRandomized group to have surgically placed graft for permanent hemodialysis access
Receives: Device: AV graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Catheter-free dialysis days

    Determine the effects of arteriovenous (AV) fistula vs. AV graft vascular access strategy on the rate of catheter-free dialysis days

    Measured: Until death, collected up to 4 years

  2. Number of Infections

    Access-related infections - catheter-related blood-stream infection, with or without sepsis, requiring hospitalization for treatment

    Measured: Until death, collected up to 4 years

Secondary outcomes (6)

  1. Vascular access-related cost per patient-year

    The total cost will represent the sum of costs for adjuvant procedures (endovascular and surgical) related to fistula or graft access; central venous catheter (CVC) - related interventions; infectious complications related to fistula or graft access; infectious complications related to CVC; and hospitalizations related to fistula or graft access and/or CVC. All access-related costs will be expressed as mean cost (in U.S. dollars) per patient per year

    Measured: Year 2

  2. Incidence rate of study fistula/graft primary maturation failure

    Study fistula or graft primary maturation failure is defined as permanent failure of the fistula or graft before hemodialysis suitability, and the study fistula or graft access was abandoned. Causes of fistula or graft primary maturation failure include inadequate vasculature, thrombosis, inability to achieve successful cannulation, and other complications leading to nonfunctional fistula or graft - Abandonment of the study fistula or graft access is defined as the point at which the fistula or graft access cannot be cannulated and no further attempts will be made to rescue or revise the access

    Measured: hour 72, Month 3, Month 6, and Year 4

  3. Time to successful fistula/graft access cannulation

    This is the time from the date of surgical creation of study AV access (fistula or graft) to the date of successful access cannulation. The date of successful access cannulation is defined as the date when the study fistula or graft access became the primary vascular access for hemodialysis (i.e., the fistula or graft access became the sole vascular access for hemodialysis and the CVC was removed)

    Measured: Until death, collected up to 4 years

  4. Incidence rate of fistula/graft access hemodialysis suitability

    Study AV access use (fistula or graft) with two needles for at least 8 out of 12 hemodialysis sessions occurring during the 30-day suitability ascertainment period

    Measured: Month 6

  5. Functional patency of study fistula or graft access

    Total duration of successful use of the study fistula or graft access (i.e., the study fistula or graft access was the sole means of hemodialysis vascular access)

    Measured: Until death, collected up to 4 years

  6. Rate of adjuvant endovascular and surgical procedures

    All endovascular and surgical procedures performed to evaluate the study fistula or graft access, or to aid or maintain study fistula or graft access functional patency will be included in this outcome. Adjuvant endovascular interventions include: percutaneous thrombectomy; percutaneous revision of anastomosis or dilation of vein/artery (e.g., angioplasty) with or without stent placement; and dilation of central venous stenosis. Adjuvant surgical interventions include: surgical thrombectomy; dilation of central venous stenosis; surgical revision of anastomosis or dilation of vein/artery (e.g., angioplasty) with or without stent placement; ligation of tributaries; superficialization of study fistula; second-stage planned procedure for brachio-basilic fistula creation; ligation of fistula or salvage by distal reconstruction and interval ligation due to distal ischemia.

    Measured: Until death, collected up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2020
  2. Study start18 Aug 2022
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Study will determine if placement of a graft access will be more effective at having access switched from catheter to using the graft; have fewer interventions on the graft access; have better arm function; have better self-sufficiency with daily activities; and better quality of life compared to those who receive a fistula - identify strategies that decrease dialysis access failure and improve quality of life
Masking
None (open label)
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04646226
Sponsor's protocol ID
IRB00069593
Other IDs
1R01AG071803-01
Status last verified
May 2026
First submitted
20 Nov 2020
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Available upon investigator request

Publications

  • Quinn RR, Oliver MJ, Wald R, Hiremath S, Pauly RP, Miller L, Barrett B, Nesrallah G, Gallagher M, Kotwal S, Gray NA, Hassan HC, Talaulikar GS, Thorpe K, Graham J, Clarke A, Bian J, MacRae J, Santana M, Bohm C, Mamdani M, Nagpal S, Yilmaz S, Moist L, Ravani P. Comparing Catheters with Fistulas in Older Patients Starting Hemodialysis: A Pilot Randomized Controlled Trial. J Am Soc Nephrol. 2026 Jun 22. doi: 10.1681/ASN.0000001160. Online ahead of print.

    PubMed 42319856

  • Murea M, Gardezi AI, Goldman MP, Hicks CW, Lee T, Middleton JP, Shingarev R, Vachharajani TJ, Woo K, Abdelnour LM, Bennett KM, Geetha D, Kirksey L, Southerland KW, Young CJ, Brown WM, Bahnson J, Chen H, Allon M. Study protocol of a randomized controlled trial of fistula vs. graft arteriovenous vascular access in older adults with end-stage kidney disease on hemodialysis: the AV access trial. BMC Nephrol. 2023 Feb 24;24(1):43. doi: 10.1186/s12882-023-03086-5.

    PubMed 36829135

Questions about this trial

What is this clinical trial studying?

A study testing AV graft and surgical intervention for creation of a fistula in people with End-Stage Kidney Disease and Hemodialysis Complication, run by Wake Forest University Health Sciences at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Catheter-free dialysis days (time frame: Until death, collected up to 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04646226, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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