NCT06314503 First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients
| NCT ID | NCT06314503 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Renal Insufficiency, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-01-22 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2024-01-22 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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
Contact & Investigator
Karin GF Gerritsen, MD, PhD
PRINCIPAL INVESTIGATOR
UMC Utrecht
Frequently Asked Questions
Who can join the NCT06314503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Renal Insufficiency, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06314503 currently recruiting?
Yes, NCT06314503 is actively recruiting participants. Contact the research team at k.g.f.gerritsen@umcutrecht.nl for enrollment information.
Where is the NCT06314503 trial being conducted?
This trial is being conducted at Modena, Italy, Utrecht, Netherlands, Madrid, Spain.
Who is sponsoring the NCT06314503 clinical trial?
NCT06314503 is sponsored by UMC Utrecht. The principal investigator is Karin GF Gerritsen, MD, PhD at UMC Utrecht. The trial plans to enroll 12 participants.