Safety Study of the WEAKID Wearable Artificial Kidney Device for Continuous Flow Peritoneal Dialysis in Adults with End-Stage Kidney Disease

What this Trial Is About

Researchers are evaluating a new peritoneal dialysis device called WEAKID for patients with end-stage kidney disease. This device offers continuous flow and regeneration of dialysis fluid inside the abdomen using sorbents to remove toxins. The study aims to assess the short-term safety of the WEAKID system in a small group of patients undergoing peritoneal dialysis with well-functioning catheters and no recent infections. Participants will receive six treatment sessions over two weeks using the WEAKID system. The first week involves treatments without the sorbent chamber for 4 to 8 hours per session, and the second week includes treatments with the sorbent chamber for the same durations. This setup allows researchers to evaluate the effects of continuous dialysate flow separately from the sorbents toxin removal. Throughout the study, participants will collect urine and dialysate samples before and during treatment. Blood samples will be taken at multiple time points, and peritoneal membrane function will be tested before and after treatment weeks. Researchers will monitor safety by tracking device-related effects, vital signs, blood chemistry, abdominal pressure, patient tolerance, and changes in uremic symptoms over a total participation period of about four weeks per participant.

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