First-in-human Study to Examine Safety of a New Peritoneal Dialysis Device (WEAKID) in End-stage Kidney Disease Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUMC Utrecht
About this trial
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
This trial does not accept healthy volunteersQualifiers
≥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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
WEAKID
DeviceSix 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
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: WEAKIDExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Serious adverse device effects (SADEs) and device deficiencies (DDs)
Serious adverse device effects (SADEs) and device deficiencies (DDs) that could have led to a serious adverse event
Time frame
This will be assessed through study completion (four weeks in total per participant)2
Critical changes in blood pressure
Critical changes requiring intervention in blood pressure (measured in mmHg; both systolic and diastolic pressures will be assessed).
Time frame
This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)3
Critical changes in heart rate
Critical changes requiring intervention in heart rate (measured in beats per minute).
Time frame
This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)4
Critical changes in body temperature
Critical changes requiring intervention in body temperature (measured in °C).
Time frame
This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)Secondary outcomes
1
Adverse events (AEs) and device deficiencies (DDs)
Assessing incidence of adverse events (AEs) and device deficiencies (DDs) other than SADEs and DDs that could have led to an serious adverse event (SAE).
Time frame
This will be assessed through study completion (four weeks in total per participant)2
Number of WEAKID treatments
The number of WEAKID treatments per patient will be determined
Time frame
The number of WEAKID treatments will be assessed for the study treatment period (2 weeks in total per participant)3
Duration of WEAKID treatments
Duration of each WEAKID treatment will be assessed (in minutes).
Time frame
This will be assessed for each WEAKID treatment throughout the study treatment period (2 weeks in total per participant)4
Dialysate flow rates during WEAKID treatment
Dialysate flow rates will be determined during each WEAKID treatment (in mL/min).
Time frame
This will be assessed during WEAKID treatment throughout the study treatment period (2 weeks in total per participant)Other outcomes
1
Baseline characteristics
At baseline, demographical, clinical, and laboratory data will be collected. These include age, gender, body mass index, blood pressure, heart rate, oxygen saturation, body temperature, medication usage, medical history (including cause of kidney failure and comorbidity scored using the Charlsons' and Davies' indices, residual kidney function, renal clearance, renal weekly Kt/V, estimated glomerular filtration rate, and dialysis-related data (duration of dialysis, PD treatment modality and scheme, peritoneal catheter type, history of peritoneal catheter dysfunction or infection, dialysis adequacy, and peritoneal weekly Kt/V.
Time frame
These will be assessed at baseline2
Peritoneal equilibrium tests
The standard peritoneal membrane analysis will be performed to determine the function of the peritoneal membrane.
Time frame
This will be assessed once at baseline and once the week after the last WEAKID treatment week (four weeks in total per participant).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
UMC Utrecht
Lead sponsor
Horizon 2020 - European Commission
Collaborator
Dutch Kidney Foundation
Collaborator
Health Holland
Collaborator
Nanodialysis Ltd
Collaborator
University of Modena and Reggio Emilia
Collaborator
Servicio Madrileno De Salud (SERMAS)
Collaborator
PPI Healthcare Consulting Ltd
Collaborator
Source ClinicalTrials.gov