Functionality of Albumin in the Context of Hemodialysis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversität Duisburg-Essen

About this trial

Hemodialysis treatment enables patients with end-stage chronic kidney disease to survive. At the same time, however, this treatment also increases cardiovascular mortality, in particular due to a chronically increased level of inflammation and usually incomplete removal of uraemic toxins. Both of these are closely linked with the functional properties of albumin.

The aim of this study is to investigate the effects of various parameters of dialysis, in particular dialyzer properties and dialysis mode on the functional properties of albumin and to what extent these parameters can be used therapeutically, to improve the treatment quality of hemodialysis treatment in the long term by modifying albumin functional properties.

Our own preliminary work in this field and the current state of research indicate that, for example, the use of high-flux dialyzers can contribute to a reduction of the oxidative stress level. It also appears possible that treatment mode (haemodiafiltration instead of haemodialysis) may also have an effect on the binding and detoxification efficiency of albumin and thus on the removal of uraemic toxins.

Previous results have mostly been collected in observational studies. As a proof-of-concept study, this study will further investigate the concrete therapeutic applicability in an interventional study design.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18 years or older at least 3 month of hemodialysis treatment (3x/week) with constant dialysis treatment regimen

Disqualifiers

Age ≤ 18 years

Less than three months of regular (3x/week) hemodialysis treatments or less than 3 treatments/week

Acute or chronic liver disease (Child stage A or higher or fulfillment of the of the Kings College criteria)

Infusion of commercial human albumin (e.g. in the context of ascites drainage) in the last three months prior to study inclusion

Trial design

Design model

Sequential

Treatments tested in this trial

  • Hemodialysis mode, dialyzer type

    Other intervention

    Change of hemodialysis mode and dialyzer type

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Single ArmOther 1 intervention

Trial outcomes

Primary outcomes

1

Level of irreversibly oxidized albumin HNA-2

change of human mercaptalbumin-2 HNA-2

Time frame
after 9 month
2

Level of albumin binding and detoxification efficiency

Change of albumin binding and detoxification efficiency, meausurement according to PMID: 37558390

Time frame
after 9 month

Secondary outcomes

Other outcomes

Sponsors and contacts

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