Completed

Protein-bound Toxin Removal with High-flux Dialyzer in Hemodialysis

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What is being tested

ELISIO21HX

Device
Who is being recruted

Infections

+ Toxemia

From 18 to 90 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2023
See protocol details

Summary

Principal SponsorChulalongkorn University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2023

Actual date on which the first participant was enrolled.

This study focuses on comparing two different kidney dialysis methods to see how well they remove certain toxins from the blood. These toxins are usually bound to proteins or are large molecules, and removing them is important for people with kidney issues. The study aims to understand which method, between hemodialysis and high-volume online hemodiafiltration, is more effective in clearing these toxins. This research is important because finding a more efficient way to clean the blood can improve the health and quality of life for patients undergoing dialysis. Participants in this study will undergo both types of dialysis methods, in a crossover manner, meaning they will switch from one method to the other during the study. The researchers will measure various outcomes, including the reduction of Beta2microglobulin and other specific proteins, as well as checking for any loss of important blood proteins like albumin. Additionally, the study will look at how these treatments affect the patients' quality of life, muscle mass, and nutritional status. Understanding these effects will help in determining the most beneficial dialysis method for patients.

Official TitleA Comparison of Protein-bound and Large Molecular Weight Uremic Toxin Removals With Novel Super High-flux Dialyzer Between Hemodialysis and High Volume Online Hemodiafiltration Modalities : A Crossover Randomized Controlled Study
Principal SponsorChulalongkorn University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

InfectionsToxemia

Criteria

2 inclusion criteria required to participate
Chronic hemodialysis patients in King Chulalongkorn Memorial hospital

Residual renal function less than 100 ml/day

7 exclusion criteria prevent from participating
Dialyzer allergy

Malnutrition requiring intradialytic parenteral nutrition

Cirrhosis child C or decompensated cirrhosis

Active uncontrolled infection

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
The dialysis mode will be set as conventional hemodialysis for 8 weeks.

Group II

Experimental
The dialysis mode will be set as predilution online hemodiafiltration for 8 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Faculty of Medicine Chulalongkorn university

Pathum Wan, ThailandOpen Faculty of Medicine Chulalongkorn university in Google Maps
CompletedOne Study Center