AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingNAAges 18 Years - anyAllUMC Utrecht
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
💊

What it tests

  • WEAKID
📍

Where

3 sites
Università degli studi di Modena e Reggio Emilia (UNIMORE)
Modena, Italy
University Medical Center Utrecht (UMCU)
Utrecht, Netherlands
Hospital Universario La Paz (SERMAS)
Madrid, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy