Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration

2019-09-30 07:07:10 | BioPortfolio


The clinical investigation will be performed to generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil obligations to follow the FX P600 dialyzer in the market.


The primary objective of this study is to test whether the FX P600 is non-inferior to the Solacea 15H dialyzer and the Elisio 150H dialyzer in removing β2-microglobulin related to the albumin removal into the dialysate during high volume online hemodiafiltration.

The secondary objective of this study is to compare the FX P600 dialyzer with the comparator dialyzers with regard to their efficacies in removing other performance variables (see below). Furthermore, the safety of the FX P600 will be investigated by collecting and analyzing clinical adverse events.

Study Design


Renal Failure




Diakonissenkrankenhaus Flensburg


Not yet recruiting


Fresenius Medical Care Deutschland GmbH

Results (where available)

View Results


Published on BioPortfolio: 2019-09-30T07:07:10-0400

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Medical and Biotech [MESH] Definitions

Condition where a primary dysfunction of either heart or kidney results in failure of the other organ (e.g., HEART FAILURE with worsening RENAL INSUFFICIENCY).

A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.

Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE. The most severe form is KIDNEY FAILURE. Renal function may deteriorate slowly (RENAL INSUFFICIENCY, CHRONIC) or precipitously (RENAL INSUFFICIENCY, ACUTE).

Functional KIDNEY FAILURE in patients with liver disease, usually LIVER CIRRHOSIS or portal hypertension (HYPERTENSION, PORTAL), and in the absence of intrinsic renal disease or kidney abnormality. It is characterized by intense renal vasculature constriction, reduced renal blood flow, OLIGURIA, and sodium retention.

A syndrome that is associated with microvascular diseases of the KIDNEY, such as RENAL CORTICAL NECROSIS. It is characterized by hemolytic anemia (ANEMIA, HEMOLYTIC); THROMBOCYTOPENIA; and ACUTE RENAL FAILURE.

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