An interventional study of Xeltis Hemodialysis Access (aXess) graft in End Stage Renal Disease, sponsored by Xeltis. Enrolling by invitation at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Xeltis · Not applicable, Interventional, and Treatment
Among 765 studies in Kidney Failure, Chronic with a site in United States — 65 open to participants now, 97 under way, 9 of them phase 3. Kidney Failure, Chronic · United States.
Among the 765 studies in Kidney Failure, Chronic with a site in United States, this one is the 175th largest by planned enrollment of the 638 interventional ones that give a count, is one of 24 that started in 2024, is one of 287 with no phase, reaches primary completion later than 64 of the 96 other live ones, and was the 725th registered.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
Browse Kidney Failure, Chronic studies →65 of the 765 studies in Kidney Failure, Chronic with a site in United States are open now. Recruiting first, the newest first:
United Therapeutics · Sites in United States
Xeno Holdings (US), LLC dba ChoironeX · Sites in United States
University of California, San Francisco · Sites in United States
Basilea Pharmaceutica · Sites in United States
University of Washington · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 170 Kidney Failure, Chronic studies recruiting now, 109 (64%) set no upper age limit and 32 (19%) stop at 75 or younger; 18 take children under 18; 22 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
765 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 119 · Phase 2 130 · Phase 3 89 · Phase 4 61
First in 1995; this study’s year is marked. 24 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 140 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Median enrollment 48 across the 638 interventional studies, 100 across the 121 observational. Of the 610 that completed or were terminated, 267 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
275 of 765 have an industry lead sponsor. The 10 most frequent:
Xeltis is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Xeltis has 4 studies filed under Kidney Failure, Chronic — fewer than ten, so there is no comparison to draw.
44 of the studies in Kidney Failure, Chronic with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04020055Phase 3Amicus TherapeuticsA Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal Disease | 2026-12-31 |
| NCT05931276Phase 3VA Office of Research and DevelopmentCSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes | 2026-12-31 |
| NCT03321656Phase 3Roberto GedalyImpact of Envarsus XR® on Kidney Biopsy Subclinical Rejection and Blood Immunologic Profile | 2027-03-31 |
| NCT05908084Phase 3Humacyte, Inc.To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis | 2027-06 |
| NCT05422534Phase 3Vanderbilt University Medical CenterCoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease | 2027-06-20 |
Among the 765 studies in Kidney Failure, Chronic with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Intra-operative exclusion criteria:
1. Unsuitable anatomy to implant the aXess graft (e.g., target vein and/or artery diameter not suitable; severe calcification).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Xeltis Hemodialysis Access (aXess) graft
The aXess graft is a sterile, restorative biodegradable polymer-based vascular graft, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess graft is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.
Secondary patency rate in survivors
Secondary patency is defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the vascular access's functionality. Patients who died or changed dialysis modality before 12 months will be excluded from the primary effectiveness analysis if loss of secondary patency was not observed before these events
Time frame: 12 months
Rate of device related infections and bleeding
Infections are defined as: All device or procedure related infections potentially resulting from surgical manipulations or device cannulation, including both minor and major infections., Bleeding (procedure or device related bleeding, at least BARC 2) and device related hematoma defined as blood accumulation around the graft arising from the implantation or cannulation that triggered a medical or surgical action
Time frame: 12 months
Freedom from device-related SAE
Time frame: Discharge, 1, 3, 6, 12, 18, 24, and 60 months
Implantation success rate
Defined as a technically successful aXess graft implantation in the planned configuration, free from kinking and tension in the anastomoses.
Time frame: 1 day, from moment of implant until discharge
Patency (primary, primary assisted, secondary, and functional) rates
Primary patency: defined as the interval between vascular access creation and the first intervention to maintain or restore patency. Assisted primary patency: defined as the interval between vascular access creation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality of the vascular access. Secondary patency: defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the vascular access's functionality Functional patency: defined as an AV access that can be cannulated with two dialysis needles for at least 75% of dialysis sessions within a 4-week period to achieve the prescribed dialysis.
Time frame: 6, 12, 18, 24, and 60 months
Time to first intervention and to access abandonment
Time frame: 60 months
Rate of access-related interventions required to achieve/maintain patency
Time frame: 6, 12, 18, 24, 60 months
Incidence rate of access site infections
Infections are defined as all device or procedure related infections potentially resulting from surgical manipulations or device cannulation, including both minor and major infections.
Time frame: 6, 12, 18, 24, and 60 months
Proportion of hemodialysis sessions completed via a central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment
Time frame: 12 months
Time to the first cannulation
Assessed only in subjects already on dialysis at the time of implant
Time frame: 12 months
Following the first cannulation, the number of days with CVC in situ (catheter contact time) during the first 12 months, irrespective of access abandonment
Time frame: 12 months
Rate of peri-reintervention vascular injuries
Time frame: 6 months
Started Nov 2024 (actual). Primary completion is estimated for Jan 2028, 38 months after the start.
Of 78 industry-sponsored interventional studies with no phase under Kidney Failure, Chronic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 40. This study's planned 38 months is above that.
Counting every sponsor, half of 425 studies reached it within 23 months; a quarter within 8 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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