Description du projet
La dialyse rénale à domicile
L’insuffisance rénale se traite au moyen de la dialyse, un processus qui filtre et purifie le sang des déchets et de l’excès de fluides. Généralement, elle s’effectue dans un établissement de soins de santé et nécessite un appareil de dialyse. L’objectif principal du projet CORDIAL, financé par l’UE, consiste à valider cliniquement un nouveau système de dialyse péritonéale (DP) portable pouvant être utilisé à domicile ou au travail. Il permet de faire circuler et de régénérer en continu le dialysat dans la cavité péritonéale afin d’assurer une purification du sang améliorée par rapport aux dispositifs conventionnels. En outre, il ne nécessite pas de concentrations élevées de glucose qui endommagent la membrane péritonéale. CORDIAL testera ce nouveau système de DP chez des patients à domicile et le comparera aux dispositifs actuellement présents sur le marché.
Objectif
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 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. 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.
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RIA - Research and Innovation actionCoordinateur
3584 CX Utrecht
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