Examining a new wearable dialysis device for kidney disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety and efficacy of a novel peritoneal dialysis device called WEAKID, designed for patients with end-stage kidney disease. The device allows for continuous flow and regeneration of dialysate, potentially improving waste removal compared to traditional methods. The study will involve 12 participants who will undergo six treatment sessions over two weeks, with careful monitoring of safety outcomes. Eligible patients must have a well-functioning peritoneal catheter and no recent infections.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥18 years of age
* Treated with PD for at least 3 months prior to enrolment
* Well-functioning peritoneal catheter and no peritoneal catheter replacement for at least a month prior to enrolment
* No PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the treatment has been finished).
* Previous or current use of Extraneal® with no contra-indications
* Capable of understanding the patient information sheet and informed consent form (ICF) and give informed consent
* Willing and able to comply with all study procedures and attend all study visits

Exclusion Criteria:

* Patients who are unable to provide informed consent
* Patients who are unable to comply with study procedures
* Patients who received renal replacement therapy other than conventional PD less than 8 weeks prior to enrolment
* Patients who participated in an intervention trial less than 8 weeks prior to enrolment or are currently participating in an intervention trial. Patients in an observational study without any interventions or in post-market surveillance do not need to be excluded.
* Patients with a PD-related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment (counting from the day that the treatment has been finished)
* Patients with peritoneal catheter dysfunction or mechanical issues less than one month prior to enrolment
* Patients who have never used Extraneal® dialysis fluid or have a contra-indication for Extraneal®: a known allergy to cornstarch or icodextrin; maltose or isomaltose intolerance; glycogen storage disease
* Patients with an incompatible PD connection to the device (e.g. Fresenius PD system)
* Patients with haemoglobin concentrations \< 6.2 mmol/L (\< 10 g/dL) less than 8 weeks prior to enrolment
* Patients with hyperkalemia (\> 6.0 mmol/L) or hyponatremia (\< 130 mmol/L) in the 8 weeks prior to enrolment
* Patients with hypocalcemia (plasma total calcium concentration corrected for albumin \<2.20 mmol/L or ionized calcium \<1.15 mmol/L) or hypomagnesemia (plasma magnesium concentration \<0.70 mmol/L) in the 8 weeks prior to enrolment
* Patients with any serious medical condition which in the opinion of the investigator, may adversely affect the safety of the participant and/or effectiveness of the study
* Female patients who are either (planning to become) pregnant within the study period or breast feeding
* Patients with a life expectancy \<3 months
* Anticipated living donor kidney transplantation \<3 months

Where it's running

• University Medical Center Utrecht (UMCU)
  Utrecht, Utrecht, Netherlands Recruiting
• Università degli studi di Modena e Reggio Emilia (UNIMORE)
  Modena, Modena, Italy Not yet recruiting
• Hospital Universario La Paz (SERMAS)
  Madrid, Madrid, Spain Not yet recruiting

Study contacts

• Principal investigator: Karin GF Gerritsen, MD, PhD — UMC Utrecht
• Study coordinator: Karin GF Gerritsen, MD. PhD
• Email: k.g.f.gerritsen@umcutrecht.nl
• Phone: +31887557375

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.