Chronic Kidney Disease Trial, Recruiting NCT06329310 Sponsor: Xeltis Condition: Chronic Kidney Disease
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Chronic Kidney Disease Trial, Recruiting

NCT06329310
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People with kidney failure (end-stage renal disease) who need a type of blood vessel access called an arteriovenous graft (AVG) placed in their arm to start or continue dialysis treatment
  • People who are at least 18 years old at the time of screening
  • People whose arm anatomy is suitable for the device, for example having a target vein of at least 5mm in diameter (confirm with trial site)
  • People who have been fully informed about the study and have signed a written consent form agreeing to take part
  • People who agree to attend follow-up appointments before and after the procedure
  • People with a life expectancy of at least 12 months

Who may not be able to join:

  • People with severe heart disease, a heart attack within the last six months, certain ongoing heart rhythm problems, or unstable chest pain
  • People whose diabetes is not well controlled
  • People with abnormal blood test results that could affect recovery or how the device functions (confirm with trial site)
  • People with significantly reduced liver function, based on specific blood test results
  • People with any active infection, whether local or throughout the body
  • People with a known history of a serious reaction to heparin that affected their platelet count (heparin-induced thrombocytopenia)
  • People with a known active bleeding disorder, clotting disorder, or history of blood clots
  • People with allergies to the device material (nitinol) or to medications such as contrast dye or aspirin, where the allergy cannot be managed medically
  • People expected to receive a kidney transplant within the next 6 months
  • People with a known or suspected blockage in a major vein on the side of the arm where the device would be placed
  • People who have had a previous dialysis access graft in the same arm, unless the new device can be placed further up the arm than the previous one
  • People who have previously taken part in this same study
  • People who are currently participating in another research study
  • Women who are pregnant, breastfeeding, or of childbearing potential who are not using adequate contraception
  • People with any other condition that, in the opinion of the study doctor, would make it difficult to properly assess the safety or performance of the device
  • People found during surgery to have anatomy that is not suitable for the device, such as blood vessels that are too small or heavily calcified

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +31 40 751 7614

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Xeltis
Registry
ClinicalTrials.gov
Start date
16 December 2024
Est. completion
1 December 2025

Where this trial is recruiting

🇵🇹 Portugal 🇷🇸 Serbia

Primary endpoints

Primary Patency rate; Freedom from device-related Serious Adverse Event (SAE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov