Xeltis Graft for Kidney Failure

Enrolling by invitation at 7 trial locations

Overseen By Sandra Kohler

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Xeltis

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Severe cardiac disease, Uncontrolled diabetes, Active infection, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of the Xeltis Hemodialysis Access (aXess) graft for individuals with severe kidney disease requiring hemodialysis. Researchers are studying the aXess graft as an option for those unable to have a fistula (a connection between an artery and a vein) created for dialysis. The trial seeks adults with end-stage kidney disease who need dialysis and are not suitable for a fistula, particularly if they have a vein at least 4mm wide in their arm. Participants will help researchers determine if this new graft is effective and safe. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

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

What prior data suggests that the aXess graft is safe for patients with end-stage kidney disease?

Research has shown that the Xeltis Hemodialysis Access (aXess) graft demonstrates promising safety results. In a first-in-human trial, patients exhibited high patency rates, meaning the graft remained open and functioned effectively. Specifically, the study found that 80% of the grafts stayed open without assistance, 95% with some help, and 100% with additional procedures, with no major safety concerns at six months. These early findings suggest that the aXess graft is generally well-tolerated and carries a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Xeltis Hemodialysis Access (aXess) graft because it offers a novel approach to creating vascular access for kidney failure patients requiring dialysis. Unlike traditional options like arteriovenous fistulas or synthetic grafts, the aXess graft is designed to encourage the patient's own tissue to grow into and integrate with the graft, potentially leading to better long-term outcomes and fewer complications. This bioresorbable scaffold technology represents a significant shift towards more natural and sustainable solutions for hemodialysis access, which could improve the quality of life for patients undergoing dialysis.

What evidence suggests that the aXess graft is effective for end-stage kidney disease?

Research has shown that the Xeltis Hemodialysis Access (aXess) graft, which participants in this trial will receive, could benefit patients with end-stage kidney disease. In a European study, the graft remained open and functional over time, which is essential for hemodialysis. An earlier study with 20 patients successfully implanted the aXess graft, demonstrating promising safety and performance. This graft is designed to be a more durable and effective option for those unable to use standard fistulas. Overall, early findings suggest that the aXess graft could significantly improve outcomes for hemodialysis patients. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with end-stage kidney disease who need a graft for hemodialysis but can't have a fistula. They should have veins big enough for the graft, expect to live at least another year, understand the study and agree to follow-ups.

Inclusion Criteria

I understand the study and agree to participate.

I agree to follow-up visits before and after the procedure.

My doctor expects me to live for at least another year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation

Implantation of the aXess graft and monitoring for immediate post-operative success

1 day

1 visit (in-person)

Treatment

Participants undergo hemodialysis using the aXess graft, with monitoring for patency and device-related complications

12 months

Follow-up

Participants are monitored for long-term safety and effectiveness of the aXess graft

60 months

What Are the Treatments Tested in This Trial?

Interventions

• Xeltis Hemodialysis Access (aXess) graft

Trial Overview The trial is testing the safety and performance of the Xeltis Hemodialysis Access (aXess) graft in patients needing dialysis access. It's a single-arm study, meaning all participants receive the same intervention without comparison to another group.

How Is the Trial Designed?

Group I: aXess graft Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Xeltis

Lead Sponsor

Trials

10

Recruited

400+

Published Research Related to This Trial

Hemodialysis is crucial for patients with end-stage renal disease, but the increasing age and comorbidities of these patients have led to a higher reliance on synthetic grafts instead of preferred arterio-venous (A-V) fistulas, which are associated with fewer complications.

The National Kidney Foundation's guidelines emphasize the importance of increasing the use of A-V fistulas due to their lower rates of complications like stenosis and thrombosis, highlighting the need for a multidisciplinary approach to optimize vascular access management in hemodialysis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular access for hemodialysis: thrills and thrombosis. Gilpin, V., Nichols, WK.[2010]

Citations

1. xeltis.com xeltis.com/category/clinical-trials/

Clinical Trials Archives Complete EU pivotal trial data highlights transformative potential of aXess in hemodialysis treatment Primary endpoint met with standout sustained patency…

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06494631

Xeltis Hemodialysis Access Graft (aXess) US Study A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in ...

3. xeltis.com xeltis.com/wp-content/uploads/2023/08/14_221007-Axess-enrolment-and-PVC-press-release_EN.pdf

221007 Axess enrolment and PVC press release FINAL pm Xeltis also reported that enrolment in the trial is now complete, with 20 patients successfully implanted with the aXess graft. During ...

4. evtoday.com evtoday.com/news/xeltis-aXess-restorative-hemodialysis-access-graft-to-be-evaluated-in-axess-fih-study-in-europe

Xeltis aXess Restorative Hemodialysis Access Graft to be ... The AXESS trial will evaluate the preliminary safety and performance of the Xeltis hemodialysis access graft in adult patients with end-stage ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38317272/

First-in-human feasibility study of the aXess graft (aXess-FIH) A prospective, single-arm, multicenter feasibility study that evaluates the early safety and performance of the aXess Hemodialysis Graft.

6. xeltis.com xeltis.com/xeltis-presents-excellent-six-month-first-in-human-data-from-axess-hemodialysis-vascular-graft-trial-at-vascular-access-society-congress/

Xeltis presents excellent six-month first-in-human data from ... In six-month data from the FIH trial, the aXess graft demonstrated high patency rates (80% primary patency, 95% primary assisted patency, 100% secondary ...

7. xeltis.com xeltis.com/xeltis-starts-the-pivotal-clinical-trial-for-axess/

Xeltis starts the pivotal clinical trial for aXess The AXESS European pivotal trial is a prospective, single arm study to evaluate the safety and performance of aXess in patients with end-stage renal disease ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04898153

NCT04898153 | First-in-Human (FIH) Study of the Xeltis ... A feasibility study is to assess the preliminary safety and performance of the Xeltis hemodialysis access (aXess) graft. Detailed Description. A prospective ...