First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients

Recruiting now · Not applicable

Conditions studied: Renal Insufficiency, Chronic, Kidney Failure, Chronic, Chronic Kidney Diseases

In brief

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).

Key facts

Study ID: NCT06314503
Run by: UMC Utrecht
People needed: 12
Starts: 2024-01-22
Expected to finish: 2025-12-31
Last updated by the study team: 2025-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

≥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

You may not qualify if…

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 is running

University Medical Center Utrecht (UMCU) — Utrecht, Utrecht, Netherlands (enrolling)
Università degli studi di Modena e Reggio Emilia (UNIMORE) — Modena, Modena, Italy
Hospital Universario La Paz (SERMAS) — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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