Clinical validation of a continuous flow peritoneal dialysis system, with dialysate regeneration

ended

Goal is the clinical validation of a new peritoneal dialysis (PD) system called CORDIAL. Instead of a stagnant filling as in traditional PD, CORDIAL continuously circulates and regenerates dialysate in the peritoneal cavity. Hereby, a significant improvement in blood purification (2-3x) can be achieved in comparison to traditional PD. For the regeneration, a sorbent unit is used to remove toxins from the peritoneal dialysate by adsorption. The sorbent system also facilitates slow release of glucose needed for osmotic removal of excess fluid (i.e. ultrafiltration). Very high glucose concentrations, as used in traditional PD and harmful to the peritoneal membrane, are no longer required, which helps to preserve the membrane function. CORDIAL is an easy to use, portable/wearable machine that allows renal patients to dialyze conveniently at home or at work, independently from a fixed water supply, up to 24 h/day. With the improved clearance and low glucose load, CORDIAL eliminates current drawbacks of PD (low efficacy, high glucose concentrations leading to damage to the peritoneal membrane), benefiting the overall health condition and quality of life (fitness, lower pill burden). In order to demonstrate clinical efficacy and safety of the system an early feasibility first-in-human (FIH) trial will be performed in PD patients. The FIH study will involve a group of 12 stable PD patients who will be treated for 6 days with the new PD system spread over two weeks (3 consecutive days per week), which will be compared with baseline measurements in the week prior and after CORDIAL treatment. In addition, an advanced computational model will be developed and validated for CORDIAL using the FIH data, which can be used to conduct virtual human trials for rapid optimization of device settings/ design and personalization of the treatment.