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NCT Number: NCT06561191

Functionality of Albumin in the Context of Hemodialysis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Essen

Essen, 45147, Germany

Location status: Recruiting

Location contact

Kristina Boss, PD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Acute or severe chronic infections
  • Acute tumor disease

Treatment and study plan

Hemodialysis mode, dialyzer type

Other

Change of hemodialysis mode and dialyzer type

Primary outcomes

  1. Level of irreversibly oxidized albumin HNA-2

    Time frame: after 9 month

    change of human mercaptalbumin-2 HNA-2

  2. Level of albumin binding and detoxification efficiency

    Time frame: after 9 month

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

Study contacts

Contact information is provided by the study sponsor or research team.

Kristina Boss, PD

CONTACT

[email protected]

00492017231868

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Effects of Dialyzer Characteristics and Dialysis Mode on Functional Properties of Albumin in Patients With Chronic Hemodialysis Treatment

Acronym: FACED

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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