Summary
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
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
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More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/754803 |
| Start date: | 01-01-2018 |
| End date: | 31-12-2023 |
| Total budget - Public funding: | 6 865 425,00 Euro - 6 440 488,00 Euro |
Cordis data
Original description
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
Status
SIGNEDCall topic
SC1-PM-10-2017Update Date
26-10-2022
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Organisations
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| UNIVERSITAIR MEDISCH CENTRUM UTRECHT (Coördinator)
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| B. BRAUN AVITUM AG
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| CHARITE - UNIVERSITAETSMEDIZIN BERLIN
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| DIAVERUM SWEDEN AB
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| FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
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| IMPERIAL COLLEGE OF SCIENCE, TECHNOLOGY AND MEDICINE
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| JULIUS CLINICAL RESEARCH BV
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| ROYAL FREE LONDON NHS FOUNDATION TRUST
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| THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD
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| UNIVERSITA DEGLI STUDI DI BARI ALDO MORO
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| UNIVERSITY COLLEGE LONDON