End Stage Renal Failure on DialysisNCT04106310
Theranova vs High-flux HD Comparison
A study testing High-flux dialyzer and Theranova dialyzer in people with End Stage Renal Failure on Dialysis, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
This research proposal of an investigator-initiated clinical study aims to examine the impact of uremic toxin removal afforded by middle cut-off (MCO) dialysis on clinical parameters and surrogate biomarkers pertinent to nutritional, systemic and vascular complications in dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure on Dialysis
- What is being tested?
- High-flux dialyzer and Theranova dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Nov 2019to 30 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients age greater than 18 years old
- end-stage renal failure on two- or three-times per week high-flux HD for more than 90 days
- mean spKt/Vurea >1.2 per session (for 3 dialysis sessions per week) or spKt/Vurea >1.8 per session (for 2 dialysis sessions per week)
Who cannot join
- active malignancy
- unable to give informed consent or complete questionnaires
- unstable clinical condition defined as significant clinical event requiring hospitalization in the past 90 days
- unreliable vascular access
- unable to achieve HD blood flow >150ml/min
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Division of Nephrology, Department of Medicine, Queen Mary Hospital
Hong Kong
Tung Wah Hospital
Hong Kong
About this study
Official title: The Comparison of Expanded Dialysis With Theranova Dialyzer With Conventional High-flux Hemodialysis
This research proposal of an investigator-initiated clinical study aims to examine the impact of uremic toxin removal afforded by middle cut-off (MCO) dialysis on clinical parameters and surrogate biomarkers pertinent to nutritional, systemic and vascular complications in dialysis patients. The primary research goal is to evaluate the outcomes indicative of nutritional status (as measured by body mass index, body composition monitoring, albumin, clinical assessments such as subjective global assessment, etc.) and parameters relevant to pathophysiological processes in uremia focusing on inflammation and cardiovascular risks. The secondary research aims are to examine dialysis efficacy between MCO dialysis and conventional hemodialysis (CHD). Specifically, dialysis efficacy will be determined by within and between subject differences in baseline versus short term (6 months) and long term (12 months) effects of MCO dialysis and CHD in:
- Removal of small molecules (e.g. urea), middle molecules (Beta-2 microglobulin, Phosphate and Creatinine) and protein bound solutes
- Markers of inflammation, ossification and fibrosis
- Uremia associated epigenetic modification The investigators hypothesize superiority of nutritional parameters in patients undergoing MCO dialysis compared with patients on CHD. The investigators plan to randomize 60 patients to either MCO dialysis or CHD at two hemodialysis units in Hong Kong.
Read the detailed description
Accumulation of uremic toxins is associated morbidity and mortality in patients with end-stage renal disease, but the pathogenic mechanisms how they lead to various clinical complications remain elusive. Conventional hemodialysis is effective in removing small molecular solutes (in the range of 50-15,000 Da), but the removal of protein-bound and middle to larger molecular toxins (up to 50,000 Da) remains unsatisfactory even with augmented hemodialysis frequency or duration. The notion that dialysis adequacy is no longer a simple quantitative measure of small molecular removal has led to the clinical application of intensive hemodialysis and the search for novel strategies to reduce uremic toxin burden.
Recently, a new class of membrane with molecular weight cut off (MWCO) close to the molecular weight of albumin was introduced. The focus of this new therapy, known as expanded dialysis using the medium cut off (MCO) dialysis membrane, is to provide the potential for more efficient removal of middle molecules and protein bound uremic toxins without excessive loss of albumin. To date, MCO dialysis has been associated with a reduction in transcription of pro-inflammatory cytokines (i.e. interleukin 6 and tumor necrosis factor-α) and middle molecules especially free lambda light chains.
Protein-energy wasting and cardiovascular diseases are prevalent in chronic kidney disease and is related to inflammation and increased mortality. Despite growing data on the clearance of individual uremic toxins and biochemical parameters, the impact of MCO dialysis on clinical outcomes and mechanistic parameters related to nutrition and inflammation remains to be investigated.
The objective of the study is to compare MCO dialysis with conventional high-flux HD, on nutritional parameters, inflammation and cardiovascular biomarkers and related clinical outcomes.
Since twice-weekly HD is commonly practiced in Hong Kong, this study provides a distinct opportunity to investigate whether MCO dialysis might be particularly advantageous in patients receiving a relatively lower dialysis dose through the removal of a broader spectrum of uremic toxins.
The investigators hypothesize that MCO dialysis with Theranova Dialyzer (HDx) improves parameters related to nutrition and inflammation compared with high-flux HD.
This will be a prospective single-blinded, randomized, controlled trial with stable HD patients randomized at 1:1 ratio to either one of the following - A. to continue with HD using the same high-flux dialyzer as in the previous 6 weeks (high-flux HD arm) B. change to HDx using Theranova Dialyzer (MCO dialysis arm)
- Conditions
- End Stage Renal Failure on Dialysis
- Being tested
- High-flux dialyzer, Theranova dialyzer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flux dialyzerDevice
a dialyzer meeting the definition of high-flux
Theranova dialyzerDevice
a middle cut-off dialyzer
| Study group | Role | What they receive |
|---|---|---|
| Theranova | Active comparator | Patients will be receiving hemodialysis using Theranova dialyzer. The other hemodialysis parameters are kept the same. Receives: Device: Theranova dialyzer |
| High-flux | Active comparator | Patients will be receiving hemodialysis using a high-flux dialyzer. The other hemodialysis parameters are kept the same Receives: Device: High-flux dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
lean tissue index
measured by Body Composition Monitor
Measured: 12 months
Body Mass Index
measured by weight (in kilograms) divided by the square of heights (in meters)
Measured: 12 months
Secondary outcomes (36)
asymmetrical dimethylarginine
endogenous inhibitor of nitric oxide synthase, one of the cardiovascular biomarkers
Measured: 12 months
fibroblast growth factor 23
biomarker for bone turnover
Measured: 12 months
Klotho
biomarker for atherosclerosis and bone turnover
Measured: 12 months
Kt/V urea
measurement of clearance of urea by hemodialysis therapy, a marker for adequacy of dialysis
Measured: 12 months
beta-2 microglobulin
middle size uremic toxin
Measured: 12 months
Pentraxin-3
middle to large molecular size uremic toxin
Measured: 12 months
soluble endothelial protein C receptor
a marker for endothelial dysfunction
Measured: 12 months
soluble thrombomodulin
a marker for endothelial dysfunction
Measured: 12 months
hemoglobulin
indication of anemia
Measured: 12 months
high-sensitive C reactive protein
marker for inflammation
Measured: 12 months
interleukin 6
marker for inflammation
Measured: 12 months
tumor necrosis factor alpha
marker for inflammation
Measured: 12 months
albumin
marker for nutritional status
Measured: 12 months
Leptin
marker for nutritional status and appetite
Measured: 12 months
adiponectin
nutritional marker
Measured: 12 months
phosphate
small size uremic waste produce
Measured: 12 months
low-density lipoprotein
reflects lipid control
Measured: 12 months
high-density lipoprotein
reflects lipid control
Measured: 12 months
triglyceride
reflects lipid control
Measured: 12 months
Malnutrition-Inflammation Score
a measurement scale reflecting nutritional status
Measured: 12 months
Subjective Global Assesment questionnaire
a measurement scale reflecting nutritional status
Measured: 12 months
fat tissue index
nutritional marker measured by Body Composition Monitor
Measured: 12 months
admission rate due to cardiovascular events
number of admisisons due to cardiovascular events during the follow-up period
Measured: 12 months
admission rate due to infection
number of admissions due to infection during the follow-up period
Measured: 12 months
mortality rate
number of deaths during the follow-up period
Measured: 12 months
5-D itch scale
Symptomatology scale to measure itchiness
Measured: 12 months
Numeric rating scale for itchiness
Symptomatology scale to measure itchiness
Measured: 12 months
The Functional Assessment of Anorexia/Cachexia Therapy (FAACT) score
measurement scale for appetite
Measured: 12 months
Visual analogue scale for appetite
measurement scale for appetite
Measured: 12 months
Postdialysis recovery time
number of time required to feel well after receiving a hemodialysis session
Measured: 12 months
Self-reported sleep quality
scale to rate the quality of sleep
Measured: 12 months
Hong Kong Montreal Cognitive Assessment
measurement of cognitive function
Measured: 12 months
KDQOLSFTMv1.3 questionnaire
quality of life assessment
Measured: 12 months
DNA methylation analysis of TRPV1 gene
epigenetics modification
Measured: 12 months
DNA methylation analysis of LY96 gene
epigenetics modificaiton
Measured: 12 months
DNA methylation analysis of IFNGR1 gene
epigenetics modifications
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Nov 2019
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Dr. Mok Ming Yee, The University of Hong Kong
- Investigators
- Maggie Ming Yee Mok, MBBS, MRCP, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106310
- Sponsor's protocol ID
- Version 1 13th Aug 2019
- Status last verified
- Sep 2021
- First submitted
- 10 Sep 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mok MMY, Yung S, Kwan LPY, Yip TPS, Lui SL, Chan TM. Expanded Hemodialysis with Theranova Compared with Conventional High-Flux Hemodialysis: Prospective Randomized 12-Month Study. Kidney360. 2025 Mar 18;6(7):1143-1157. doi: 10.34067/KID.0000000769.
PubMed 40100276
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Expanded Dialysis With Theranova Dialyzer With Conventional High-flux Hemodialysis
- ClinicalTrials.gov ID
- NCT04106310
- Acronym / sponsor ID
- Version 1 13th Aug 2019
- Conditions
- End Stage Renal Failure on Dialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 27 Sep 2019 (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.
This research proposal of an investigator-initiated clinical study aims to examine the impact of uremic toxin removal afforded by middle cut-off (MCO) dialysis on clinical parameters and surrogate biomarkers pertinent to nutritional, systemic and vascular complications in dialysis patients. The primary research goal is to evaluate the outcomes indicative of nutritional status (as measured by body mass index, body composition monitoring, albumin, clinical assessments such as subjective global assessment, etc.) and parameters relevant to pathophysiological processes in uremia focusing on inflammation and cardiovascular risks. The secondary research aims are to examine dialysis efficacy between MCO dialysis and conventional hemodialysis (CHD). Specifically, dialysis efficacy will be determined by within and between subject differences in baseline versus short term (6 months) and long term (12 months) effects of MCO dialysis and CHD in:
- Removal of small molecules (e.g. urea), middle molecules (Beta-2 microglobulin, Phosphate and Creatinine) and protein bound solutes
- Markers of inflammation, ossification and fibrosis
- Uremia associated epigenetic modification The investigators hypothesize superiority of nutritional parameters in patients undergoing MCO dialysis compared with patients on CHD. The investigators plan to randomize 60 patients to either MCO dialysis or CHD at two hemodialysis units in Hong Kong.
Detailed description
Accumulation of uremic toxins is associated morbidity and mortality in patients with end-stage renal disease, but the pathogenic mechanisms how they lead to various clinical complications remain elusive. Conventional hemodialysis is effective in removing small molecular solutes (in the range of 50-15,000 Da), but the removal of protein-bound and middle to larger molecular toxins (up to 50,000 Da) remains unsatisfactory even with augmented hemodialysis frequency or duration. The notion that dialysis adequacy is no longer a simple quantitative measure of small molecular removal has led to the clinical application of intensive hemodialysis and the search for novel strategies to reduce uremic toxin burden.
Recently, a new class of membrane with molecular weight cut off (MWCO) close to the molecular weight of albumin was introduced. The focus of this new therapy, known as expanded dialysis using the medium cut off (MCO) dialysis membrane, is to provide the potential for more efficient removal of middle molecules and protein bound uremic toxins without excessive loss of albumin. To date, MCO dialysis has been associated with a reduction in transcription of pro-inflammatory cytokines (i.e. interleukin 6 and tumor necrosis factor-α) and middle molecules especially free lambda light chains.
Protein-energy wasting and cardiovascular diseases are prevalent in chronic kidney disease and is related to inflammation and increased mortality. Despite growing data on the clearance of individual uremic toxins and biochemical parameters, the impact of MCO dialysis on clinical outcomes and mechanistic parameters related to nutrition and inflammation remains to be investigated.
The objective of the study is to compare MCO dialysis with conventional high-flux HD, on nutritional parameters, inflammation and cardiovascular biomarkers and related clinical outcomes.
Since twice-weekly HD is commonly practiced in Hong Kong, this study provides a distinct opportunity to investigate whether MCO dialysis might be particularly advantageous in patients receiving a relatively lower dialysis dose through the removal of a broader spectrum of uremic toxins.
The investigators hypothesize that MCO dialysis with Theranova Dialyzer (HDx) improves parameters related to nutrition and inflammation compared with high-flux HD.
This will be a prospective single-blinded, randomized, controlled trial with stable HD patients randomized at 1:1 ratio to either one of the following - A. to continue with HD using the same high-flux dialyzer as in the previous 6 weeks (high-flux HD arm) B. change to HDx using Theranova Dialyzer (MCO dialysis arm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theranova | Active comparator | Device: Theranova dialyzerPatients will be receiving hemodialysis using Theranova dialyzer. The other hemodialysis parameters are kept the same. |
| High-flux | Active comparator | Device: High-flux dialyzerPatients will be receiving hemodialysis using a high-flux dialyzer. The other hemodialysis parameters are kept the same |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patients age greater than 18 years old
- end-stage renal failure on two- or three-times per week high-flux HD for more than 90 days
- mean spKt/Vurea >1.2 per session (for 3 dialysis sessions per week) or spKt/Vurea >1.8 per session (for 2 dialysis sessions per week)
Key exclusion criteria (5 listed)
- active malignancy
- unable to give informed consent or complete questionnaires
- unstable clinical condition defined as significant clinical event requiring hospitalization in the past 90 days
- unreliable vascular access
- unable to achieve HD blood flow >150ml/min
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 |
|---|---|---|
| High-flux dialyzera dialyzer meeting the definition of high-flux | Device | High-flux |
| Theranova dialyzera middle cut-off dialyzer | Device | Theranova |
Primary outcome
lean tissue index
Time frame: 12 months
measured by Body Composition Monitor
Body Mass Index
Time frame: 12 months
measured by weight (in kilograms) divided by the square of heights (in meters)
36 secondary outcomes
asymmetrical dimethylarginine
Time frame: 12 months
fibroblast growth factor 23
Time frame: 12 months
Klotho
Time frame: 12 months
Kt/V urea
Time frame: 12 months
beta-2 microglobulin
Time frame: 12 months
Pentraxin-3
Time frame: 12 months
soluble endothelial protein C receptor
Time frame: 12 months
soluble thrombomodulin
Time frame: 12 months
hemoglobulin
Time frame: 12 months
high-sensitive C reactive protein
Time frame: 12 months
interleukin 6
Time frame: 12 months
tumor necrosis factor alpha
Time frame: 12 months
albumin
Time frame: 12 months
Leptin
Time frame: 12 months
adiponectin
Time frame: 12 months
phosphate
Time frame: 12 months
low-density lipoprotein
Time frame: 12 months
high-density lipoprotein
Time frame: 12 months
triglyceride
Time frame: 12 months
Malnutrition-Inflammation Score
Time frame: 12 months
Subjective Global Assesment questionnaire
Time frame: 12 months
fat tissue index
Time frame: 12 months
admission rate due to cardiovascular events
Time frame: 12 months
admission rate due to infection
Time frame: 12 months
mortality rate
Time frame: 12 months
5-D itch scale
Time frame: 12 months
Numeric rating scale for itchiness
Time frame: 12 months
The Functional Assessment of Anorexia/Cachexia Therapy (FAACT) score
Time frame: 12 months
Visual analogue scale for appetite
Time frame: 12 months
Postdialysis recovery time
Time frame: 12 months
Self-reported sleep quality
Time frame: 12 months
Hong Kong Montreal Cognitive Assessment
Time frame: 12 months
KDQOLSFTMv1.3 questionnaire
Time frame: 12 months
DNA methylation analysis of TRPV1 gene
Time frame: 12 months
DNA methylation analysis of LY96 gene
Time frame: 12 months
DNA methylation analysis of IFNGR1 gene
Time frame: 12 months
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 29 Sep 2021.
- Derived from this study: PubMed 40100276Mok MMY, Yung S, Kwan LPY, Yip TPS, Lui SL, Chan TM. Expanded Hemodialysis with Theranova Compared with Conventional High-Flux Hemodialysis: Prospective Randomized 12-Month Study. Kidney360. 2025 Mar 18;6(7):1143-1157. doi: 10.34067/KID.0000000769.
- Individual participant dataSharing planned: No
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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.
Maggie Ming Yee Mok, MBBS, MRCP principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flux dialyzer and Theranova dialyzer in people with End Stage Renal Failure on Dialysis, run by The University of Hong Kong at 2 sites in Hong Kong.
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 3 inclusion and 5 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 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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?
lean tissue index (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04106310, which also lists 1 linked publication.
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 29 Sep 2021.