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WEAKID SIGNED

Clinical validation of miniature wearable dialysis machine

Total Cost €

0

EC-Contrib. €

0

Partnership

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Project "WEAKID" data sheet

The following table provides information about the project.

Coordinator
UNIVERSITAIR MEDISCH CENTRUM UTRECHT 

Organization address
address: HEIDELBERGLAAN 100
city: UTRECHT
postcode: 3584 CX
website: www.umcutrecht.nl

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Netherlands [NL]
 Project website http://www.weakid.eu/
 Total cost 3˙306˙750 €
 EC max contribution 3˙306˙750 € (100%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-SC1-2016-RTD
 Funding Scheme RIA
 Starting year 2017
 Duration (year-month-day) from 2017-01-01   to  2019-06-30

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    UNIVERSITAIR MEDISCH CENTRUM UTRECHT NL (UTRECHT) coordinator 1˙168˙125.00
2    NANODIALYSIS BV NL (Oirschot) participant 984˙750.00
3    UNIVERSITA DEGLI STUDI DI MODENA E REGGIO EMILIA IT (MODENA) participant 597˙250.00
4    SERVICIO MADRILENO DE SALUD ES (MADRID) participant 556˙625.00

Map

 Project objective

The project aims to validate a miniature wearable dialysis machine in a clinical setting and to prepare the system for CE-marking. Wearable 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 wearable 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. 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. 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 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.

 Deliverables

List of deliverables.
Webportal, social media in place Websites, patent fillings, videos etc. 2019-08-07 12:34:25

Take a look to the deliverables list in detail:  detailed list of WEAKID deliverables.

 Publications

year authors and title journal last update
List of publications.
2018 Maaike K. van Gelder
A miniature artificial kidney for peritoneal dialysis – WEAKID’
published pages: , ISSN: , DOI:
ERA-EDTA congress 2018, Poster (FP448) 26-05-18 2019-08-07
2018 Maaike K. van Gelder
A miniature artificial kidney for peritoneal dialysis – WEAKID
published pages: , ISSN: , DOI:
Dutch Nephrology Days 2018 28-03-18 2019-08-07
2018 Van Gelder MK, Simonis F, Hazenbrink DHM, Ligabue G, Cappelli G, Bajo Rubio MA, Selgas R,Joles JA, Gerritsen KFG.
A miniature artificial kidney for peritoneal dialysis – WEAKID
published pages: , ISSN: , DOI:
Dutch Nephrology Days 2018 March 2018 2019-08-07
2018 Ligabue G, Simonis F, Fontana F, Giovanella S, Bianchini E, Hazenbrink DHM, Gerritsen KGF,Bajo Rubio MA, Selgas R, Cappelli G.
Effects on mesothelial cells from direct oxidation of peritoneal dialysate: are GDPs the real culprits?
published pages: , ISSN: , DOI:
ESAO Congress 2018 September 2018 2019-08-07
2018 Van Gelder MK, Simonis F, Hazenbrink DHM, Ligabue G, Cappelli G, Bajo Rubio MA, Selgas R,Joles JA, Gerritsen KFG.
A miniature artificial kidney for peritoneal dialysis – WEAKID
published pages: , ISSN: , DOI:
ERA-EDTA Congress 2018 May 2018 2019-08-07
2017 Karin G.F. Gerritsen
Nanodialysis Technology and Experience
published pages: , ISSN: , DOI:
ASAIO American Society for Artificial Organs 22-06-17 2019-08-07
2017 Maaike K. van Gelder
The wearable artificial kidney: current status
published pages: , ISSN: , DOI:
Retreat for Dutch Pediatricians “Nier op Schier”, invited lecture 27-09-17 2019-08-07
2017 Maaike K. van Gelder
Development of the wearable artificial kidney
published pages: , ISSN: , DOI:
Hans Boter Symposium, invited lecture 12-10-17 2019-08-07
2017 Karin G.F. Gerritsen
The wearable artificial kidney: current status
published pages: , ISSN: , DOI:
Research symposium organized by the Dutch Kidney-Patient Association (NVN). invited lecture 13-10-17 2019-08-07
2018 Maarten Wester, Maaike K. van Gelder, Jaap A Joles, Frank Simonis, Diënty H.M. Hazenbrink, Theo W.M. van Berkel, Koen R.D. Vaessen, Walther H. Boer, Marianne C. Verhaar, Karin G.F. Gerritsen
Removal of urea by electro-oxidation in a miniature dialysis device: a study in awake goats
published pages: , ISSN: 1931-857X, DOI: 10.1152/ajprenal.00094.2018
American Journal of Physiology-Renal Physiology 2019-08-07
2018 Gerritsen, Karin
WEAKID - Clinical validation of miniature wearable dialysis machine - H2020
published pages: pp. 55-57(3), ISSN: , DOI: 10.21820/23987073.2018.3.55
Impact Volume 2018, Number 3, June 201 2019-08-07
2018 Maaike K. van Gelder, Silvia M. Mihaila, Jitske Jansen, Maarten Wester, Marianne C. Verhaar, Jaap A. Joles, Dimitrios Stamatialis, Roos Masereeuw, Karin G. F. Gerritsen
From portable dialysis to a bioengineered kidney
published pages: 323-336, ISSN: 1743-4440, DOI: 10.1080/17434440.2018.1462697
Expert Review of Medical Devices 15/5 2019-08-07
2018 Karin G.F. Gerritsen
The wearable artificial kidney
published pages: , ISSN: , DOI:
Dutch Nephrology Days (NND) 2018, invited lecture 27-3-18 2019-08-07
2017 Karin G.F. Gerritsen
The wearable artificial kidney: current status
published pages: , ISSN: , DOI:
DOMESTICO symposium, invited lecture 23-11-2017 2019-08-07

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The information about "WEAKID" are provided by the European Opendata Portal: CORDIS opendata.

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