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

Objective

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 and a crossover feasibility trial will be performed in PD patients. The FIH study will involve a group of 12 stable PD patients in an hospital setting for 5 consecutive days. Upon successful functionality and safety analysis of the FIH 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 at low glucose concentrations and (3) does not show important safety/ biocompatibility problems. Hereto 30 stable PD patients will be randomized to receive at home either CORDIAL treatment in the first 2 months and traditional PD in the month 3 and 4 or vice versa.

Call for proposal

H2020-SC1-2020-Two-Stage-RTD
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Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 1 085 248,56

Participants (4)

NANODIALYSIS BV
Netherlands
EU contribution
€ 965 625
Address
De Korenaar 83
5688RX Oirschot
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA
Italy
EU contribution
€ 812 323,75
Address
Via Universita 4
41121 Modena
Activity type
Higher or Secondary Education Establishments
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 519 527,51
Address
Plaza Carlos Trias Bertran 7
28020 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
PPI HEALTHCARE CONSULTING LTD
United Kingdom
EU contribution
€ 99 500
Address
The White House Main Road
OX14 3PX Abingdon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)