NCT06314503Recruiting
First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients
Clinical Validation of a Continuous Flow Peritoneal Dialysis System With Dialysate Regeneration
Source: ClinicalTrials.gov · Last updated 18 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this first-in-human clinical trial is to examine the safety and efficacy of treatment with a new peritoneal dialysis (PD) device called WEAKID (WEarable Artificial KIDney for peritoneal dialysis). This device, unlike conventional PD, allows for continuous flow of dialysate inside the abdominal cavity combined with continuous regeneration of spent dialysate thanks to sorbents that remove toxins from the fluid. The study will include PD patients of 18 years or older with a well-functioning peritoneal catheter and no history of a PD-related infection for at least eight weeks prior to enrolment. The main purpose of this study is to assess the (short-term) safety of the WEAKID system in a limited number (n=12) of patients and sessions. Participants will undergo six treatment sessions (of four or eight hours) in total over a period of two weeks, either with or without a sorbent chamber. Participants will be asked to collect urine and dialysate the week before the first treatment and during the treatment days. In addition, blood samples will be collected before and during the treatment weeks in order to compare the effects of conventional PD with that of WEAKID treatment. A peritoneal equilibrium test will also be done before and after the treatment weeks to test the function of the lining of the abdomen (the peritoneal membrane).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 1 Jan 2024
- Start date
- 22 Jan 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- UMC Utrecht
- Diseases
- Chronic kidney disease
- NCT number
- NCT06314503
What you commit to
- Study type: Interventional
- Planned participants: 12
- From 22 Jan 2024 to the primary completion date, 31 Dec 2025
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Anticipated living donor kidney transplantation \<3 months
Other illness
- 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 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
Lab values
- 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
Other
- Patients who are unable to provide informed consent
- Patients who are unable to comply with study procedures
- Patients with an incompatible PD connection to the device (e.g. Fresenius PD system)
- Female patients who are either (planning to become) pregnant within the study period or breast feeding
- Patients with a life expectancy \<3 months
Who the study is looking for
- ≥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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universario La Paz (SERMAS) Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Università degli studi di Modena e Reggio Emilia (UNIMORE) Coordinator of this site? Confirm its status | Modena | Italy | Not yet recruiting |
| University Medical Center Utrecht(UMCU) Coordinator of this site? Confirm its status | Utrecht | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.