An interventional study of aXess-E conduit in End Stage Renal Disease, sponsored by Xeltis. Recruiting at 2 sites in 2 countries. 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 19 studies in Kidney Failure, Chronic with a site in Portugal — 4 open to participants now, 6 under way, 2 of them phase 3. Kidney Failure, Chronic · Portugal.
Among the 19 studies in Kidney Failure, Chronic with a site in Portugal, this one is the 14th largest by planned enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2024, is one of 2 with no phase, and was the 19th registered.
2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
Browse Kidney Failure, Chronic studies →4 of the 19 studies in Kidney Failure, Chronic with a site in Portugal are open now. Recruiting first, the newest first:
CSL Behring · Sites in Portugal, United States, Argentina and 32 more countries
Oncorena AB · Sites in Portugal, United States, France and 2 more countries
Rigshospitalet, Denmark · Sites in Portugal, Argentina, Austria and 33 more countries
A study can be open while its sites in Portugal have not opened yet or have stopped. Only those recruiting at a site in Portugal →
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.
19 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 1 · Phase 2 5 · Phase 3 8 · Phase 4 1
First in 1994; this study’s year is marked. 2 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.
Median enrollment 400 across the 15 interventional studies, 8,213 across the 4 observational. Of the 12 that completed or were terminated, 7 (58%) have results posted.
This tab as a report to print or save as PDF → With an account.
16 of 19 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.
2 of the studies in Kidney Failure, Chronic with a site in Portugal that are under way reach primary completion within a year, 1 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 |
| NCT06329310XeltisXeltis Hemodialysis Access (aXess) Conduit: aXess-E Study | 2027-07 |
Among the 19 studies in Kidney Failure, Chronic with a site in Portugal, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
A prospective, single arm, non-randomized feasibility study to confirm the safety and performance of the Xeltis Hemodialysis Access conduit, aXess-E, in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.
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-E conduit (e.g. target vein and/or artery diameter smaller than anticipated; 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.
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 share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is 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.
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.
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.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
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: aXess-E conduit
The aXess-E conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, 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-E conduit is able to support both straight and loop configurations and may be implanted in the upper arm and forearm.
Primary Patency rate
Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Time frame: 6 months
Freedom from device-related Serious Adverse Event (SAE)
Time frame: 6 months
Implantation success rate
Defined as a technically successful aXess-E conduit implantation in the planned configuration, free from kinking and tension in the anastomoses.
Time frame: 1 day, from moment of implant until end of procedure day
Primary patency rate
Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Time frame: 6, 12, 18, and 24 months
Primary assisted patency rate
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 the vascular access.
Time frame: 6, 12, 18, and 24 months
Secondary patency rate
Secondary patency: Defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up).
Time frame: 6, 12, 18, and 24 months
Functional patency rate
Functional patency: Defined as the interval between first cannulation and abandonment, including occurrence of a censored event (death, change of modality, loss of follow-up).
Time frame: 6, 12, 18, and 24 months
Time (expressed in months) to first intervention and to access abandonment
Time frame: 24 months
Rate of access-related interventions required to achieve/maintain patency
Time frame: 6, 12, 18, and 24 months
Freedom from device-related SAE
Time frame: 12, 18, and 24 months
Rate of access site infections
Time frame: 6, 12, 18, and 24 months
Proportion of hemodialysis sessions completed via central venous catheter (CVC) during the first 12 months of access creation and access cannulation, irrespective of access abandonment
Time frame: 24 months
Time to first cannulation
Assessed only in subjects who are already on dialysis at the time of implant.
Time frame: 24 months
Following first cannulation, number of days with CVC in situ (catheter contact time) irrespective of access abandonment
Time frame: 12 months
Started Dec 2024 (actual). Primary completion is estimated for Jul 2027, 31 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 31 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.
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