An observational study in Chronic Kidney Diseases and End Stage Renal Disease on Dialysis, sponsored by W.L.Gore & Associates. Recruiting at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by W.L.Gore & Associates · Observational
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Among 109 studies in Kidney Failure, Chronic with a site in Germany — 9 open to participants now, 15 under way, 4 of them phase 3. Kidney Failure, Chronic · Germany.
Among the 109 studies in Kidney Failure, Chronic with a site in Germany, this one is the 15th largest by planned enrollment of the 23 observational ones that give a count, is one of 4 that started in 2024, is one of 23 observational ones, reaches primary completion later than 5 of the 14 other live ones, and was the 102nd registered.
2,109 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
Browse Kidney Failure, Chronic studies →9 of the 109 studies in Kidney Failure, Chronic with a site in Germany are open now. Recruiting first, the newest first:
CSL Behring · Sites in Germany, United States, Argentina and 32 more countries
Ages 18+
Iperboreal Pharma Srl · Sites in Germany, Denmark, Italy and 3 more countries
Ages 18+
Dicerna Pharmaceuticals, Inc., a Novo Nordisk company · Sites in Germany, United States, France and 7 more countries
University of Sydney · Sites in Germany, Australia, Canada and 3 more countries
Ages 18+
Heidelberg University · Sites in Germany, United States, Austria and 12 more countries
Ages 1 days–90 yrs · Healthy volunteers
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 169 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.
109 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 13 · Phase 2 16 · Phase 3 26 · Phase 4 9
First in 1994; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 72 is below the median of 120 across 443 observational studies indexed under Kidney Failure, Chronic.
Median enrollment 81 across the 86 interventional studies, 119 across the 23 observational. Of the 85 that completed or were terminated, 26 (31%) have results posted.
This tab as a report to print or save as PDF → With an account.
65 of 109 have an industry lead sponsor. The 10 most frequent:
W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
W.L.Gore & Associates has 6 studies filed under Kidney Failure, Chronic — fewer than ten, so there is no comparison to draw.
4 of the studies in Kidney Failure, Chronic with a site in Germany that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03994471Phase 3Iperboreal Pharma SrlEfficacy and Safety of XyloCore Peritoneal Dialysis Solution. | 2026-12-31 |
| NCT05970172Phase 3Astellas Pharma Global Development, Inc.A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease | 2027-10-30 |
| NCT02823821University of SydneyRandomised Evaluation of Sodium Dialysate Levels on Vascular Events | 2026-12 |
| NCT05846581W.L.Gore & AssociatesRegistry of GORE® ACUSEAL Vascular Graft in Dialysis Access | 2027-10-27 |
Add all 4 to your calendar (.ics) → With an account.
Among the 109 studies in Kidney Failure, Chronic with a site in Germany, 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.
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are:
Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.
This is a European, Observational, Non-Interventional, Prospective, Non-Randomized, Single Arm, Multicenter, PMCF Registry to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. There is no comparator device.
The aim of study is to obtain real-world observational evidence about the use of the device.
The AVG 22-09 registry consists of End-Stage Renal Disease (ESRD) patients who require hemodialysis access through Vascular Graft per the evaluating physician.
A total of 72 subjects will be implanted in this registry with a limit of 25 subjects implanted per site.
The registry has been designed with standard eligibility criteria to enroll subjects for which the registry device is intended to treat. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted. All patients must provide informed consent prior to any registry related procedures being performed and the patient is considered enrolled when informed consent is obtained.
The primary objective is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft in hemodialysis access for the treatment of Chronic Kidney Disease (CKD) in patients with End Stage Renal Disease (ESRD).
All patients who sign an informed consent will be considered enrolled and at the completion of study participation, subjects will be advised by their respective clinical centers on the appropriate follow up regimen to be followed but it is expected that the each implanted subject will be evaluated through hospital discharge and return for follow-up visits per site standard of care.
Each enrolled and implanted subject will be followed for 24 months.
2,109 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.
This study's planned enrollment of 72 is below the median of 120 across 443 observational studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →W.L.Gore & Associates is the lead sponsor of 96 studies on the registry; 20 are open to participants now.
Compared within Kidney Failure, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Renal Insufficiency, Chronic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Registry subject population - those patients with CKD in ESRD that require hemodialysis access through the GORE® ACUSEAL Vascular Graft meeting the inclusion and exclusion criteria will be eligible for screening for participation in this registry.
The registry has been designed with broad eligibility criteria to capture real-world GORE® ACUSEAL Vascular Graft use, for which the device is intended to be implanted. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted.
No vulnerable populations are included in this registry.
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:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Patient population - patients with CKD in ESRD that require hemodialysis access through the GORE® ACUSEAL Vascular Graft. Registry subject population - those patients with CKD in ESRD that require hemodialysis access through the GORE® ACUSEAL Vascular Graft meeting the inclusion and exclusion criteria will be eligible for screening for participation in this registry. The registry has been designed with broad eligibility criteria to capture real-world GORE® ACUSEAL Vascular Graft use, for which the device is intended to be implanted. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted. No vulnerable populations are included in this registry.
Device: GORE® ACUSEAL Vascular Graft
The device placement will be performed according to each participating site's standard practice. No specific procedures are required by the protocol. At the time of the GORE® ACUSEAL Vascular Grafts implantation, procedural and adverse event information will be collected.
Primary Safety Endpoint. Number of subjects free from device-related infection at 24 months from device implant.
Events will be computed as follows: 1. All subjects who had a registry device related AE with an Infection MedDRA code within 730 days from device implant will be tabulated as 'Not Free from Infection'. 2. All subjects who completed the registry and were infection free at 24 months from the registry procedure will be considered free from device related infection. All relevant infection MedDRA terms will be agreed upon by the Office of Medical Affairs within Gore. This endpoint will be treated as a patient-based binomial proportion, and no formal hypothesis will be tested. A Kaplan Meir analysis will also be done to account for censoring.
Time frame: 24 months from device implant
Primary Performance Endpoint. Secondary Patency at 24 months: The time from device implant to complete abandonment of the access site for hemodialysis regardless of the number of interventions required to restore or maintain patency.
Events will be computed as follows: 1. All subjects who have an abandonment or explant of the registry graft within 730 days will have lost secondary patency. The date will be noted on the discontinuation form. 2. All subjects who completed the registry within 730 days without a graft abandonment will be considered patent. 3. If a subject did not complete the registry for a reason other than graft abandonment or explant, they will be censored. A Kaplan Meir analysis will be done to account for censoring.
Time frame: 24 months from device implant
Percentage of GORE® ACUSEAL Vascular Grafts cannulated within 1, 2, 3, 7, and 14 days from device implant.
The percentage of GORE® ACUSEAL Grafts cannulated within 24, 48,72,168, and 336 hours post device implant will be computed as follows: 1\. The hours from end time of procedure to the first successful hemodialysis session performed through the GORE® ACUSEAL Graft will be recorded per subject. This endpoint will be treated as a patient-based binomial proportion and will be summarized as percent with a 95% confidence interval.
Time frame: Cannulation within 1, 2, 3, 7 and 14 days from device implant.
Percentage of Subjects free from bleeding events through 6, 12, and 24 months from device implant.
1. All subjects experiencing an adverse event classified as bleeding prior to the end of the designated window will be counted as having a bleeding event within that interval. 2. Subjects not experiencing case 1, who have had a follow-up visit after the beginning of the designated interval, are declared as having no bleeding event. 3. All subjects not experiencing case 1 or 2 will not be included in computations for the corresponding interval. A Kaplan Meir analysis will be done to account for censoring.
Time frame: 6, 12, and 24 months from device implant
Secondary Patency at 6 and 12 months: The time from device implant to complete abandonment of the access site for hemodialysis regardless of the number of interventions required to restore or maintain patency.
Events will be computed as follows: 1. All subjects who have an abandonment or explant of the registry graft within 730 days will have lost secondary patency. The date will be noted on the discontinuation form. 2. All subjects who completed the registry within 730 days without a graft abandonment will be considered patent. 3. If a subject did not complete the registry for a reason other than graft abandonment or explant, they will be censored. A Kaplan Meir analysis will be done to account for censoring.
Time frame: 6 and 12 months from device implant.
Primary patency at 6, 12 and 24 months from device implant. Time interval of uninterrupted patency from device implant to the next access thrombosis or intervention.
Primary Patency will be calculated at 6 months, 12 months, and 24 months from device implant, and will use the following decision rules: 1. Subjects who have a repeat intervention, thrombosis event, abandonment or explant of the registry graft prior to the end of the analysis window will have lost patency. 2. Subjects who have not experienced case 1, and had a follow-up visit within the desired analysis window are considered patent. 3. All other subjects will be censored. A Kaplan Meir analysis will be done to account for censoring.
Time frame: 6, 12 and 24 months from device implant.
Not enrolling at this site.
Started Jan 2024 (actual). Primary completion is estimated for Oct 2027, 45 months after the start.
Of 150 observational studies under Kidney Failure, Chronic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 62. This study's planned 45 months is above that.
How these figures are worked out, and which studies are left out of them.
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