End-stage kidney disease, peritoneal dialysis
Conditions
Interventions
 
The WEAKID system will be tested in a clinical setting on 6 days over a period 
of 2 weeks. During the first week, the subjects will be treated with the 
nighttime system without sorbents for 4h (first day) or 8h (second and third 
day) during daytime. The second week, treatment will consist of the nighttime 
system with sorbents (also 4h (first day) or 8h (second and third day) during 
daytime). This way, exposure to new components of the system is incremental and 
the effectiveness of the sorbents can be analyzed separately from the effect of 
continuous recirculating flow dialysis. A peritoneal equilibration test (PET) 
will be performed at baseline and follow-up. In addition, patients will collect 
24h spent peritoneal dialysate and 24h urine followed by venous puncture for 
blood sampling 3 times prior to WEAKID treatment during standard PD. 
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • >=18 years of age. • Treated with peritoneal dialysis 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
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 PD related infection (exit-site infection, tunnel infection or peritonitis) less than 8 weeks prior to enrolment. • 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®: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety objective will be assessed by describing and examining the incidence of: • serious adverse device effects (SADE) and device deficiencies (DD) that could have led to a serious adverse event (SAE) • critical changes (requiring intervention) in patient*s clinical condition and vital parameters (blood pressure, heart rate, body temperature and oxygen saturation) during treatment. • critical changes (requiring intervention) in hematology and clinical chemistry (i.a. acid base state, electrolytes) pre- vs post-treatment. • critical changes (requiring intervention) in intra-abdominal dialysate volume and intra-abdominal pressure during treatment Evaluation of the events described above will be used to evaluate the short-term safety of WEAKID treatment. No formal statistical hypotheses will be tested. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: 1. Assessing incidence of adverse events and DD*s other than SADE*s and DD*s that could have led to a SAE 2. Session characteristics (number, duration, dialysate flow rates) 3. Evolution of vital signs (blood pressure, heart rate, body temperature and oxygen saturation) 4. Efficacy of UF in relation to glucose concentration in device effluent • Ultrafiltration volume, peak glucose concentration in the device effluent, amount of glucose that is adsorbed and UF efficiency (volume of osmotic water removal per gram absorbed glucose) • Peak glucose concentration in device effluent required to achieve appropriate osmotic water removal should be similar or lower than the peak glucose concentrations in the peritoneal dialysate during standard PD in each patient (if WEAKID treatment takes place according to the intended use) 5. Efficacy of solute removal and base release of WEAKID treatment: • Absolute removal of urea, creatinine, phosphate, potassium, beta-2 microglobulin (B2M) • MTAC and plasma clearance of urea, creatinine, phosphate, potassium, B2M • Plasma reduction ratio of protein bound uremic toxins (PBUTs) • Net release of base to the patient (i.e. bicarbonate plus lactate) 6. Evolution of blood analytes • Before and after a WEAKID session: uremic toxins (urea, creatinine, uric acid, B2M, PBUTs), phosphate, potassium, hematological parameters, bicarbonate, lactate, sodium, chloride, calcium, magnesium, glucose, LDH, vitamin B12. • Before and after a series of 3 WEAKID sessions: CRP, liver enzymes and bilirubin* 7. Evolution of dialysate effluent analytes • Dialysate effluent analytes should be comparable to existing commercially available peritoneal dialysate formulations and should match the range of PD effluents during standard PD 8. (Technical) device performance • Number of device deficiencies (DD) and adverse device effects (ADE). • Evolution of delta intraperitoneal pressure during WEAKID treatment (i.e. intraperitoneal pressure during | — |
Countries
Italy, Netherlands, Spain
Contacts
Public ContactK.G.F. Gerritsen
Universitair Medisch Centrum Utrecht
Outcome results
None listed