WEAKID: Six treatments over the course of two weeks with the WEAKID system:
* Week 1 (without the sorbents)
* Day 1: four-hour treatment
* Day 2: eight-hour treatment
* Day 3: eight-hour treatment
* Week 2 (with the sorbents)
* Day 1: four-hour treatment
* Day 2: eight-hour treatment
* Day 3: eight-hour treatment
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Serious adverse device effects (SADEs) and device deficiencies (DDs) — This will be assessed through study completion (four weeks in total per participant) Serious adverse device effects (SADEs) and device deficiencies (DDs) that could have led to a serious adverse event
Critical changes in blood pressure — This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant) Critical changes requiring intervention in blood pressure (measured in mmHg; both systolic and diastolic pressures will be assessed).
Critical changes in heart rate — This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant) Critical changes requiring intervention in heart rate (measured in beats per minute).
Critical changes in body temperature — This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant) Critical changes requiring intervention in body temperature (measured in °C).
Critical changes in oxygen saturation — This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant) Critical changes requiring intervention in oxygen saturation (measured in %).
Critical changes in plasma potassium — This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant) Critical changes requiring intervention in plasma potassium (before and after WEAKID treatment in mmol/L).
Critical changes in plasma calcium — This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant) Critical changes requiring intervention in plasma calcium (before and after WEAKID treatment in mmol/L).
Critical changes in plasma bicarbonate — This will be assessed before (at t=0 minutes) and after (at t=240 minutes or t=480 minutes for the 4-hour and 8-hour treatment, respectively) the WEAKID treatment throughout the study treatment period (2 weeks in total per participant) Critical changes requiring intervention in plasma bicarbonate (before and after WEAKID treatment in mmol/L).
Critical changes in intra-abdominal dialysate volume — This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant) Critical changes requiring intervention in intra-abdominal dialysate volume.
Critical changes in intra-abdominal pressure — This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant) Critical changes requiring intervention in intra-abdominal dialysate pressure (in mbar).
Trial sites (3)
Facility
City
Region
Status
Università degli studi di Modena e Reggio Emilia (UNIMORE)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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