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

Launched by UMC UTRECHT · Mar 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called WEAKID, designed to improve a treatment called peritoneal dialysis for patients with end-stage kidney disease. The WEAKID device works differently from traditional methods by continuously flowing and cleaning the dialysis fluid inside the abdomen, which helps remove toxins more effectively. The main goal of this study is to check the safety of the WEAKID system in a small group of patients who are already receiving peritoneal dialysis.

To participate in this trial, patients need to be at least 18 years old, have been on peritoneal dialysis for at least three months, and have a well-functioning catheter without any recent infections. Participants will undergo six treatment sessions over two weeks, and during this time, they will provide urine and blood samples to help researchers compare the new device's effects with standard treatment. It’s important to note that this study is currently recruiting participants, and anyone interested should review the eligibility criteria carefully.

Gender

ALL

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