Examining a new wearable dialysis device for kidney disease patients
Clinical Validation of a Continuous Flow Peritoneal Dialysis System With Dialysate Regeneration
This study is testing a new wearable dialysis device for people with end-stage kidney disease to see if it works better and is safe compared to regular dialysis methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 3 sites (Modena, Modena and 2 other locations) |
| Trial ID | NCT06314503 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been on peritoneal dialysis for at least three months and have a well-functioning catheter.
Not a fit: Patients who have had recent infections related to peritoneal dialysis or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could significantly enhance the quality of life for patients undergoing peritoneal dialysis by improving waste removal and reducing complications.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving dialysis techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Modena, Modena and 2 other locations
- Università degli studi di Modena e Reggio Emilia (UNIMORE) — Modena, Modena, Italy (Not_yet_recruiting)
- University Medical Center Utrecht (UMCU) — Utrecht, Utrecht, Netherlands (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.