Uremic; ToxemiaNCT06567483
A Comparison of Protein-bound and Large Molecular Weight Uremic Toxin Removals With Novel Super High-flux Dialyzer Between Hemodialysis and High Volume Online HDF Modalities
A study testing ELISIO21HX in people with Uremic; Toxemia, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The goal of this prospective, randomized, crossover study is to study about using super high-flux dialyzer in the chronic hemodialysis patients. The main questions aim to answer are the reduction ratio of protein bound uremic toxins Participants will undergone the pre-dilution online hemodiafiltration and conventional… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Uremic; Toxemia
- What is being tested?
- ELISIO21HX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2023to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chronic hemodialysis patients in King Chulalongkorn Memorial hospital
- Residual renal function less than 100 ml/day
Who cannot join
- Dialyzer allergy
- Malnutrition requiring intradialytic parenteral nutrition
- Cirrhosis child C or decompensated cirrhosis
- Active uncontrolled infection
- Active cardiovascular disease
- Advanced stage malignancy
- Predicted to be undergone living related kidney transplant within 1 year
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Chulalongkorn university
Pathum Wan, Bangkok, 10330
About this study
Official title: A 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
The goal of this prospective, randomized, crossover study is to study about using super high-flux dialyzer in the chronic hemodialysis patients.
The main questions aim to answer are the reduction ratio of protein bound uremic toxins
Participants will undergone the pre-dilution online hemodiafiltration and conventional hemodialysis for each 8 weeks followed by washout phase for 4 weeks.
Read the detailed description
Other secondary outcomes that the researcher wants to study are
- The reduction ratio of Beta2microglobulin, kappa and lambda free light chain
- Serum albumin and dialysate albumin loss
- Quality of life, muscle mass and nutritional status of the patients
- Conditions
- Uremic; Toxemia
- Being tested
- ELISIO21HX
- Keywords
- Super High-flux dialyzers, Medium cut-off membrane, Protein bound uremic toxin, Indoxyl sulfate, Dialysate albumin loss, Albumin, Kappa free light chain, Lambda free light chain, Pre-dilution online HDF, Conventional hemodialysis
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISIO21HXDevice
Also called Super-high flux dialyzer
Super-high flux dialyzers (ELISIO21HX) will be used. The blood flow rate and dialysate flow rate will be set as 400 and 800 ml/min respectively for 4 hours of dialysis.
| Study group | Role | What they receive |
|---|---|---|
| Predilution online hemodiafiltration | Experimental | The dialysis mode will be set as predilution online hemodiafiltration for 8 weeks. Receives: Device: ELISIO21HX |
| Hemodialysis | Active comparator | The dialysis mode will be set as conventional hemodialysis for 8 weeks. Receives: Device: ELISIO21HX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein bound uremic toxin reduction ratio (percent)
The reduction ratio of indoxyl sulfate will be calculated as percent by pre and post dialysis data. The measurement will take place in the pre-dialysis of the first and the last time of intervention
Measured: 8 weeks
Secondary outcomes (3)
Beta2 microglobulin, kappa and lambda free light chain and urea reduction ratio (percent)
The reduction ratio of the beta2 microglobulin, kappa and lambda free light chain and urea will be measure at the first and the last time of intervention by pre and post dialysis level.
Measured: 8 weeks
Serum albumin and dialysate albumin loss
Serum albumin will be followed at the midweek pre-dialysis at the first and 8th weeks of intervention.
Dialysate albumin will also be assessed at the 1st and the 8th weeks.
Measured: 8 weeks
Quality of life assessment in each group
Quality of life was assessed by the KDQOL36 questionnaire in each intervention
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start1 May 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uremic; ToxemiaStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- After a run-in period, the patients were randomly allocated to receive either 8-week of predilution hemodiafiltration using super-high flux, ELISIO-21HX, or hemodialysis using super-high flux as the control treatment. After a wash-out period of hemodiafiltration using high flux dialyzer, they were assigned to receive the other treatment for 8 weeks.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rossanun Shoosanglertwijit, MD, Chulalongkorn University
- Investigators
- Rossanun Shoosanglertwijit, Principal investigator, Chulalongkorn UniversityKhajohn Tiranathanagul, Principal investigator, Chulalongkorn UniversityPajaree Chariyavilaskul, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567483
- Sponsor's protocol ID
- 051466
- Status last verified
- Aug 2024
- First submitted
- 13 Mar 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Share only the results of the study.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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
- ClinicalTrials.gov ID
- NCT06567483
- Acronym / sponsor ID
- 051466
- Conditions
- Uremic; Toxemia
- Keywords
- Super High-flux dialyzers, Medium cut-off membrane, Protein bound uremic toxin, Indoxyl sulfate, Dialysate albumin loss, Albumin, Kappa free light chain, Lambda free light chain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this prospective, randomized, crossover study is to study about using super high-flux dialyzer in the chronic hemodialysis patients.
The main questions aim to answer are the reduction ratio of protein bound uremic toxins
Participants will undergone the pre-dilution online hemodiafiltration and conventional hemodialysis for each 8 weeks followed by washout phase for 4 weeks.
Detailed description
Other secondary outcomes that the researcher wants to study are
- The reduction ratio of Beta2microglobulin, kappa and lambda free light chain
- Serum albumin and dialysate albumin loss
- Quality of life, muscle mass and nutritional status of the patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After a run-in period, the patients were randomly allocated to receive either 8-week of predilution hemodiafiltration using super-high flux, ELISIO-21HX, or hemodialysis using super-high flux as the control treatment. After a wash-out period of hemodiafiltration using high flux dialyzer, they were assigned to receive the other treatment for 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Predilution online hemodiafiltration | Experimental | Device: ELISIO21HXThe dialysis mode will be set as predilution online hemodiafiltration for 8 weeks. |
| Hemodialysis | Active comparator | Device: ELISIO21HXThe dialysis mode will be set as conventional hemodialysis for 8 weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic hemodialysis patients in King Chulalongkorn Memorial hospital
- Residual renal function less than 100 ml/day
Key exclusion criteria (7 listed)
- Dialyzer allergy
- Malnutrition requiring intradialytic parenteral nutrition
- Cirrhosis child C or decompensated cirrhosis
- Active uncontrolled infection
- Active cardiovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISIO21HXAlso: Super-high flux dialyzerSuper-high flux dialyzers (ELISIO21HX) will be used. The blood flow rate and dialysate flow rate will be set as 400 and 800 ml/min respectively for 4 hours of dialysis. | Device | Hemodialysis, Predilution online hemodiafiltration |
Primary outcome
Protein bound uremic toxin reduction ratio (percent)
Time frame: 8 weeks
The reduction ratio of indoxyl sulfate will be calculated as percent by pre and post dialysis data. The measurement will take place in the pre-dialysis of the first and the last time of intervention
3 secondary outcomes
Beta2 microglobulin, kappa and lambda free light chain and urea reduction ratio (percent)
Time frame: 8 weeks
Serum albumin and dialysate albumin loss
Time frame: 8 weeks
Quality of life assessment in each group
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: No. Share only the results of the study.
Related trials for Uremic; Toxemia
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CKD (Chronic Kidney Disease) Stage 5D, Uremia; Chronic
Recruiting
Prognostic Role of the Uremic Toxin Indoxyl Sulfate on Vascular and Cardiac Functions During Acute Kidney Injury
Acute Kidney Injury, Uremic; Toxemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rossanun Shoosanglertwijit principal investigator
Chulalongkorn University
Khajohn Tiranathanagul principal investigator
Chulalongkorn University
Pajaree Chariyavilaskul principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISIO21HX in people with Uremic; Toxemia, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein bound uremic toxin reduction ratio (percent) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.