Xeltis Graft for Kidney Failure

Recruiting at 4 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

140 Participants Needed

Trial Summary

What is the purpose of this trial?

A multi-center, prospective, single-arm, non-randomized, staged, pivotal clinical study to evaluate the safety and performance of the aXess graft in subjects aged 18 and above, diagnosed with end-stage kidney disease, and possessing an estimated glomerular filtration rate (eGFR) less than 20 ml/min, who intend to undergo hemodialysis but are considered unsuitable candidates for fistula creation by the investigating surgeon.

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 data supports the effectiveness of the Xeltis Hemodialysis Access (aXess) graft treatment for kidney failure?

The aXess Hemodialysis Graft is designed to become a natural blood vessel over time, potentially reducing issues like infection and blockage that are common with other grafts. This innovative approach may offer better long-term results for patients needing hemodialysis access. ^{1 2 3 4 5}

What makes the Xeltis Hemodialysis Access (aXess) graft treatment unique for kidney failure?

The Xeltis Hemodialysis Access (aXess) graft is unique because it is made from a porous polymeric biomaterial that allows cells to grow into it, eventually turning into a natural blood vessel as the graft is absorbed by the body. This approach aims to reduce the risk of infection and clotting, which are common issues with traditional arteriovenous grafts. ^{1 5 6 7 8}

Eligibility Criteria

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 veins are wide enough for a graft implant.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: aXess graft Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Xeltis

Lead Sponsor

Trials

10

Recruited

400+

Findings from Research

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]

References

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

Kidney allograft dysfunction due to ipsilateral thigh arteriovenous graft. [2020]

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

Vascular access for hemodialysis: thrills and thrombosis. [2010]

3. Germany pubmed.ncbi.nlm.nih.gov

Creation of a novel hemodialysis bridge graft to extend the life of an adolescent. [2018]

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

The straight radial-antecubital PTFE angio-access graft in an era of high-flux dialysis. [2019]

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

Study protocol of a prospective single-arm multicenter clinical study to assess the safety and performance of the aXess hemodialysis graft: The pivotal study. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

[Axillo-axillary access in hemodialysis]. [2017]

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

Renal transplantation for the hemodialysis patient with axillofemoral bypass. [2004]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Single Asian Center Experience Using the Flixene™ Early Cannulation Graft for Hemodialysis Access Creation. [2021]