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Functionality of Albumin in the Context of Hemodialysis

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06561191
Acronym
FACED
Enrollment
50
Registered
2024-08-19
Start date
2024-08-01
Completion date
2025-12-31
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Albumin, Dialysis, Redox State, Uremic; Toxemia

Brief summary

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.

Interventions

OTHERHemodialysis mode, dialyzer type

Change of hemodialysis mode and dialyzer type

Sponsors

Universität Duisburg-Essen
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Level of irreversibly oxidized albumin HNA-2after 9 monthchange of human mercaptalbumin-2 HNA-2
Level of albumin binding and detoxification efficiencyafter 9 monthChange of albumin binding and detoxification efficiency, meausurement according to PMID: 37558390

Countries

Germany

Contacts

Primary ContactKristina Boss, PD
kristina.boss@uk-essen.de00492017231868

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026