New system for dialysis patients for improved outcome

In a close collaboration between the UMC Utrecht and Nanodialysis BV, this project successfully realized a redesign of a new peritoneal dialysis device, completed a preclinical validation program and started a first-in-human study.

Patients with end-stage kidney failure who cannot be transplanted or are on the waiting list for transplantation are dependent on dialysis. There are two variants: abdominal dialysis (peritoneal dialysis, PD) and blood dialysis (hemodialysis, HD). PD offers patients the opportunity for dialysis at home, but has important disadvantages including relatively low blood purification and short technique survival. To improve this, we have developed a new device for PD that continuously circulates and purifies the flushing fluid (dialysate), therewith improving blood purification and removal of excess fluid. In addition, we expect to improve the technique survival by using lower glucose concentrations that are less harmful to the abdominal membrane.

Despite major hurdles, such as COVID-19, significant progress in the development of the device was realized. The device was made suitable for (overnight) use in patients and equipped with a remote monitoring system. A preclinical validation program was conducted which included extensive testing in the laboratory and in pigs showing a clear improvement in removal of waste solutes. The device also appeared to be safe. Biocompatibility testing according to ISO 10993 standard was successfully completed.

With these results, the next step could be taken to test the device in patients. Permission for a first-in-human trial was obtained in 2023. The trial is currently ongoing and the first patients have been successfully treated.

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