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The Comparison of High-Dose Heamodiafiltration (HDF) versus Haemodialyse

Objective

End stage kidney disease ranks among the most severe chronic non-communicable diseases with an unmet medical need, given the high (between 10 and 15%) and stable annual mortality rates. Kidney replacement therapy is necessary when kidney function is below 10% of the normal value. Much effort is put into developing strategies to prevent chronic kidney disease progression. Regenerative medicine still is in the experimental phase and kidney transplantation is only available for a small number of patients. Indeed, the everyday reality is the growing number of dialysis patients. Haemodialysis treatment is the current standard of care for the vast majority of patients with end stage kidney disease. It is a substantial burden to the patient and for society. Haemodialysis treatment is associated with high risks for fatal and non-fatal cardiovascular disease, for infections, hospitalisation and low quality of life. Improvement in the currently available standard is urgently needed.

Over the past decade an alternative for haemodialysis became available, i.e. haemodiafiltration. Both are accepted by regulatory authorities. Haemodiafiltration removes waste products that are accumulated due to kidney failure, more effecticvely than standard hemodialysis. Present evidence supports the idea of superiority of haemodialfiltration compared to standard haemodialysis. However, definite proof is lacking and as a consequence haemodiafiltration is not yet widely applied.

This consortium aims to determine the best possible dialysis treatment by comparing the conventional guideline based haemodialysis treatment versus high-dose haemodiafiltration by carrying out a prospective randomized controlled clinical trial addressing clinical endpoints, quality of life and a cost-utility analysis. The study will deliver an answer on the question which intervention gives the best value for money. Therefore, it will be considered a “land mark” study, allowing to publish an “end of discussion” paper

Call for proposal

H2020-SC1-2017-Two-Stage-RTD
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Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Address
Heidelberglaan 100
3584 CX Utrecht
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 573 062,50

Participants (9)

JULIUS CLINICAL RESEARCH BV
Netherlands
EU contribution
€ 2 256 001,50
Address
Broederplein 41-43
3703 CD Zeist
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
United Kingdom
EU contribution
€ 361 190
Address
Wellington Square University Offices
OX1 2JD Oxford
Activity type
Higher or Secondary Education Establishments
ROYAL FREE LONDON NHS FOUNDATION TRUST
United Kingdom
EU contribution
€ 413 593,75
Address
Pond Street Hampstead
NW3 2QG London
Activity type
Research Organisations
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
Germany
EU contribution
€ 850 675
Address
Else Kroener Strasse 1
61352 Bad Homburg
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
B. BRAUN AVITUM AG
Germany
EU contribution
€ 510 537,50
Address
Schwarzenberger Weg 73-79
34212 Melsungen
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
DIAVERUM SWEDEN AB
Sweden
EU contribution
€ 701 550
Address
Trollebergsvagen 5
227 22 Lund
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
UNIVERSITA DEGLI STUDI DI BARI ALDO MORO
Italy
EU contribution
€ 9 687,50
Address
Piazza Umberto I 1
70121 Bari
Activity type
Higher or Secondary Education Establishments
CHARITE - UNIVERSITAETSMEDIZIN BERLIN
Germany
EU contribution
€ 555 127
Address
Chariteplatz 1
10117 Berlin
Activity type
Higher or Secondary Education Establishments
UNIVERSITY COLLEGE LONDON
United Kingdom
EU contribution
€ 209 063,75
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments