Functionality of Albumin in the Context of Hemodialysis

NCT06561191 | Recruiting

• 1 other identifier: 2024_EKEA.29
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Albumin; Dialysis; Redox State; Uremic; Toxemia

Outcome Measures

Primary Outcomes (2)

• Level of irreversibly oxidized albumin HNA-2

  change of human mercaptalbumin-2 HNA-2

  after 9 month

• Level of albumin binding and detoxification efficiency

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

  after 9 month

Study Arms (1)

Single Arm

OTHER

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

Interventions

Hemodialysis mode, dialyzer type OTHER

Change of hemodialysis mode and dialyzer type

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)
• Acute or severe chronic infections
• Acute tumor disease

Sponsors & Collaborators

• Universität Duisburg-Essen: lead

Study Sites (1)

University Hospital Essen

Essen, 45147, Germany

RECRUITING

MeSH Terms

Conditions

Toxemia

Condition Hierarchy (Ancestors)

Infections

Central Study Contacts

Kristina Boss, PD

CONTACT

00492017231868; kristina.boss@uk-essen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. Kristina Boss

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

DE (1)