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

Ki vehet részt

• ≥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

Ki nem vehet részt

• 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
• Anticipated living donor kidney transplantation <3 months
• 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 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
• 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 who are unable to provide informed consent
• Patients who are unable to comply with study procedures
• Patients with an incompatible PD connection to the device (e.g. Fresenius PD system)
• Female patients who are either (planning to become) pregnant within the study period or breast feeding
• Patients with a life expectancy <3 months