Chronic Kidney Disease Trial, Recruiting NCT06314503 Sponsor: UMC Utrecht Condition: Chronic Kidney Disease
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Chronic Kidney Disease Trial, Recruiting

NCT06314503
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 aged 18 or older
  • People who have been receiving peritoneal dialysis (a type of kidney treatment that filters waste through the abdomen) for at least 3 months before joining
  • People whose peritoneal dialysis catheter (the tube used for the treatment) is working well and has not been replaced in the past month
  • People who have not had a dialysis-related infection — such as an infection at the catheter exit site, in the tunnel under the skin, or inside the abdomen — within the past 8 weeks (counted from when treatment for that infection finished)
  • People who have previously used or are currently using a dialysis fluid called Extraneal®, and have no medical reasons preventing its use
  • People who are able to understand the study information and consent forms, and are willing to give their consent to participate
  • People who are willing and able to follow all study procedures and attend all required study visits

Who may not be able to join:

  • People who are unable to give informed consent to participate
  • People who are unable to follow the study procedures
  • People who received a different type of kidney replacement therapy (other than standard peritoneal dialysis) within the past 8 weeks
  • People who took part in another intervention-based clinical trial within the past 8 weeks, or who are currently in one (note: being in an observational study or product monitoring study without any active interventions does not apply here — confirm with trial site)
  • People who had a dialysis-related infection within the past 8 weeks (counted from when treatment for that infection finished)
  • People who had problems with their dialysis catheter not working properly or had mechanical issues with it in the past month
  • People who have never used Extraneal® dialysis fluid, or who have a medical reason preventing its use — including a known allergy to cornstarch or icodextrin, an inability to process maltose or isomaltose, or a condition called glycogen storage disease
  • People whose dialysis connection equipment is not compatible with the study device (for example, those using a Fresenius peritoneal dialysis system)
  • People who had low red blood cell levels (anaemia below a certain threshold) in the 8 weeks before joining
  • People who had abnormal blood potassium levels (too high) or abnormal blood sodium levels (too low) in the 8 weeks before joining
  • People who had abnormal blood calcium or magnesium levels (too low) in the 8 weeks before joining
  • People with a serious medical condition that, in the opinion of the study doctor, could affect their safety or the reliability of the study results
  • People who are pregnant, planning to become pregnant during the study period, or currently breastfeeding
  • People with a life expectancy of less than 3 months
  • People who are expected to receive a living donor kidney transplant within the next 3 months

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 26 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

Principal Investigator: Karin GF Gerritsen, MD, PhD, UMC Utrecht

Phone: +31887557375

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
UMC Utrecht
Registry
ClinicalTrials.gov
Start date
22 January 2024
Est. completion
31 December 2025

Where this trial is recruiting

🇮🇹 Italy 🇳🇱 Netherlands 🇪🇸 Spain

Primary endpoints

Serious adverse device effects (SADEs) and device deficiencies (DDs); Critical changes in blood pressure; Critical changes in heart rate; Critical changes in body temperature; Critical changes in oxygen saturation; Critical changes in plasma potassium; Critical changes in plasma calcium; Critical changes in plasma bicarbonate; Critical changes in intra-abdominal dialysate volume; Critical changes in intra-abdominal pressure

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: 26 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