Functionality of Albumin in the Context of Hemodialysis (FACED)
Effects of Dialyzer Characteristics and Dialysis Mode on Functional Properties of Albumin in Patients With Chronic Hemodialysis Treatment
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kristina Boss, PD
- Phone Number: 00492017231868
- Email: kristina.boss@uk-essen.de
Study Locations
-
-
-
Essen, Germany, 45147
- Recruiting
- University Hospital Essen
-
Contact:
- Kristina Boss, PD
- Email: kristina.boss@uk-essen.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Single Arm
All patients recieve three month of treatment with hemodialysis, hemodiafiltraten, treatment with high flux dialyzer and treatment with low flux dialyzer
|
Change of hemodialysis mode and dialyzer type
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of irreversibly oxidized albumin HNA-2
Time Frame: after 9 month
|
change of human mercaptalbumin-2 HNA-2
|
after 9 month
|
|
Level of albumin binding and detoxification efficiency
Time Frame: after 9 month
|
Change of albumin binding and detoxification efficiency, meausurement according to PMID: 37558390
|
after 9 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024_EKEA.29
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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