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WEAKID PROJECT

The WEAKID project aims to validate a miniature wearable/portable dialysis machine in a clinical setting and to prepare the system for CE-marking. The duration of the project is 30 months (Jan 2017 - June 2019).

Wearable/portable dialysis

Wearable/portable dialysis allows renal patients to dialyze conveniently and continuously at home or at work, independently from a fixed water supply, up to 24 hrs/day. Such a continuous treatment mimics healthy kidneys and is twice as effective as current dialysis techniques, hereby offering health benefits, quality of life (fitness, mobility) while reducing medical costs (less medication, dialysis at home lowers costs). The miniature dialysis system is based on continuous flow peritoneal dialysis with a fluidic access to the abdomen. The peritoneal dialysate is continuously circulated and refreshed by means of a small and wearable sorption unit that removes toxins from the dialysate. The technology has been demonstrated in preclinial research. The technology is suited both for wearable dialysis (24 hrs/day) and for portable dialysis (8 hrs/night).


Clinical studies

In order to demonstrate the clinical efficacy and safety of the system an early feasibility first-in- human trial (phase 0) and a pilot crossover trial (phase 1) will be performed in peritoneal dialysis (PD) patients with the portable/night system. The phase 0 study will involve a selected group of 12 stable PD patients in a clinical setting for 5 consecutive days. Upon successful functionality and safety analysis of the phase 0 trial, the clinical validation is continued in a crossover study to test the hypotheses that the system (1) improves blood purification, (2) results in adequate ultrafiltration and (3) does not show important safety/ biocompatibility problems. Hereto 30 stable PD patients will be randomised to receive either with the wearable/portable system in the first month and conventional PD in the second month or vice versa. The clinical trials will be performed by three European medical centres specialised in dialysis treatment.

PARTNERS

The WEAKID project is carried out by the following partners:
  • UMCU medical center Utrecht (NL)
  • UNIMORE medical center Modena (IT)
  • Nanodialysis BV Oirschot (NL)
  • SERMAS medical center Madrid (SP)

Contact

Please send your request to: info@weakid.eu






This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 733169.



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