Functionality of Albumin in the Context of Hemodialysis (FACED)

August 17, 2024 updated by: Kristina Boss, Universität Duisburg-Essen

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Hemodialysis mode, dialyzer type
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

This is where you will find people and organizations involved with this study.

Sponsor

Universität Duisburg-Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 17, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 19, 2024

Last Update Submitted That Met QC Criteria

August 17, 2024

Last Verified

August 1, 2024

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)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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