CORDIAL clinical trial with a novel peritoneal dialysis device completed end of 2025!

Peritoneal dialysis (PD) is one of the two dialysis entities to treat patients with end-stage renal disease. In contrast to haemodialysis, no vascular access is needed for PD and it allows for more patient autonomy, since patients can perform the treatment by themselves at home without having to go to a center or hospital. However, PD often has a short technique survival and the treatment efficiency is suboptimal. Furthermore, the quality of life of patients on (peritoneal) dialysis should be further improved. Therefore, our group at the UMCU has been working together with the CORDIAL consortium partners (including Nanodialysis, UNIMORE in Italy, SERMAS in Spain, and PPI Healthcare consulting) on making a new dialysis device called WEarable Artificial KIDney (WEAKID) available to patients dependent on dialysis treatment.

WEAKID is a device meant for automated PD that works differently in two ways compared to the standard of care: (1) it uses continuous flow of dialysate in the abdomen rather than static dwells, and (2) is uses sorbent-based dialysate regeneration to reduce the total amount of dialysate needed. Besides, the device is smaller and weighs considerably less than the current PD devices (only ~4.5 kg instead of ~13.5 kg). Therefore, the WEAKID device might tackle the current PD shortcomings: it is expected to  improve treatment efficiency, to improve quality of life, and to enlengthen technique survival due to a lower glucose load needed (which is harmful for the peritoneal membrane).

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The new WEAKID device consisting of a carrier (on the left) and a dialysate reservoir (on the right).

After extensive in vitro and in vivo testing, the next step was to test the device in patients, in a so-called First-In-Human study. The First-In-Human study started at the beginning of January, 2024. During this study, patients on PD tested the new device during two weeks (six WEAKID treatments per participant) and safety and efficacy data were collected. In total, 12 patients have been treated with the WEAKID device during the study and the final study visit occurred in December, 2025. Both safety and efficacy data look promising. The final data analysis will now be performed and the study is expected to be published in a peer-reviewed journal before the end of 2026. The results of the study will form the basis for the redesign of the device, further improving its functioning and usability. All in all, by completing the CORDIAL First-In-Human trial, we were able to realize a crucial first step towards bringing this new device to the market and, hopefully, improving patients’ lives.

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