End Stage Renal DiseaseTHREADNCT04211571
Theranova Versus High-flux Dialyzer on Preservation of Residual Renal Function
A study testing Theranova 400 dialyzer and High-flux dialyzer in people with End Stage Renal Disease, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Theranova is a novel medium cut-off dialyzer and has better performance for removal of middle molecules compared to conventional hemodialysis. The study investigates the effect of Theranova dialzyer on preserving residual renal function in the incident hemodialysis pateitns compared to high-flux dialzyer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Theranova 400 dialyzer and High-flux dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Apr 2020to 24 Sep 2023
- 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
- Incident end-stage renal disease ESRD patient receiving hemodialysis for less than 1 month
- 18 years old and older
- Creatinine clearance of more than 2 ml/min
- Agreement to participate in the clinical study
- Vascular access by arteriovenous fistula/graft
Who cannot join
- Plan for kidney transplantation within 6 months
- Severe volume overloading state
- Dialysis through permanent catheter
- Any hematologic malignancy or monoclonal gammopathy
- Any malignancy
- Active infectious disease
- HIV infection
- Patient enrolled to another study within 3 month from starting the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of REsidual RenAl Function in Incident HemoDialysis Patients (THREAD)
Theranova is a novel medium cut-off dialyzer and has better performance for removal of middle molecules compared to conventional hemodialysis. The study investigates the effect of Theranova dialzyer on preserving residual renal function in the incident hemodialysis pateitns compared to high-flux dialzyer. The primary endpoint is change of glomerular filtration rate, calculated using creatinine and urea clearance. The secondary endpoints are serial changes of glomerular filtration rate and daily urine volume, changes of serum middle molecule concentrations, hospitalization, mortality, and patient reported outcomes.
- Conditions
- End Stage Renal Disease
- Being tested
- Theranova 400 dialyzer, High-flux dialyzer
- Keywords
- End-stage renal disease, Medium cut-off dialyzer, High-flux dialyzer, Residual renal function
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theranova 400 dialyzerDevice
Hemodialysis using Theranova 400 dialyzer
High-flux dialyzerDevice
Also called Fx CorDiax 80 dialyzer
Hemodialysis using high-flux dialyzer
| Study group | Role | What they receive |
|---|---|---|
| MCO group | Experimental | Hemodialysis using Theranova 400 dialyzer Receives: Device: Theranova 400 dialyzer |
| High-flux group | Active comparator | Hemodialysis using high-flux dialyzer (Fx CorDiax 80; Fresenius Medical Care) Receives: Device: High-flux dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of glomerular filtration rate
Glomerular filtration rate is calculated as the mean of creatinine and urea clearance adjusted for body surface area. The outcome refers to the mean difference of glomerular filtration rate between baseline and after 12 months.
Measured: Between baseline and 12 months
Secondary outcomes (11)
Change of glomerular filtration rate
Calculated as the mean of creatinine and urea clearance adjusted for body surface area
Measured: 0, 3, 6, 9, 12 months
Change of daily urine volume
Total urine output for 24 hours
Measured: 0, 3, 6, 9, 12 months
Change and reduction ratio of inflammatory marker levels
TNF-alpha, GDF-15, etc.
Measured: 0, 12 months
Change of hs-CRP
hs-CRP
Measured: 0, 12 months
Change of Beta 2-microglobulin
Beta 2-microglobulin
Measured: 0, 12 months
Change of kidney injury markers
NGAL, KIM-1, TIMP-2, IGFBP-7, etc
Measured: 0, 12 months
Change of cystatin-C
Cystatin-C
Measured: 0, 12 months
Change and reduction ratio of Kappa and lambda free light chains
Kappa and lambda free light chains
Measured: 0, 12 months
Hospitalization
Frequency, cause, etc.
Measured: Through 12-month study duration
Mortality
Deaths number and causes of death
Measured: Through 12-month study duration
Patient-reported outcome
Using Kidney Disease Quality of Life Questionnaire-36™ (KDQOL-36™; score ranges from 0 to 100 - higher scores represent better quality of life)
Measured: 0, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2019
- Study start23 Apr 2020
- Primary completion17 Sep 2023
- Study completion24 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyungpook National University Chilgok Hospital, Yeungnam University Hospital, Ewha Womans University, Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Yong-Lim Kim, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04211571
- Sponsor's protocol ID
- KNU-Theranova-01
- Acronym
- THREAD
- Status last verified
- Nov 2023
- First submitted
- 21 Dec 2019
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.
PubMed 27587605Lim JH, Seo YJ, Jeon Y, Jeon YH, Jung HY, Choi JY, Park SH, Kim CD, Kang SH, Ryu JH, Kang DH, Cho JH, Kim YL. Expanded Hemodialysis with Theranova Dialyzer and Residual Kidney Function in Patients Starting Long-Term Hemodialysis: A Randomized Controlled Trial. J Am Soc Nephrol. 2025 Mar 4;36(8):1614-1625. doi: 10.1681/ASN.0000000655.
PubMed 40036081
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Theranova Versus High-flux Dialyzer on Preservation of REsidual RenAl Function in Incident HemoDialysis Patients (THREAD)
- ClinicalTrials.gov ID
- NCT04211571
- Acronym / sponsor ID
- THREAD / KNU-Theranova-01
- Conditions
- End Stage Renal Disease
- Keywords
- End-stage renal disease, Medium cut-off dialyzer, High-flux dialyzer, Residual renal function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Collaborators
- Kyungpook National University Chilgok Hospital, Yeungnam University Hospital, Ewha Womans University, Baxter Healthcare Corporation
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 17 Sep 2023 (actual)
- Study completion
- 24 Sep 2023 (actual)
- First posted
- 26 Dec 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.
Theranova is a novel medium cut-off dialyzer and has better performance for removal of middle molecules compared to conventional hemodialysis. The study investigates the effect of Theranova dialzyer on preserving residual renal function in the incident hemodialysis pateitns compared to high-flux dialzyer. The primary endpoint is change of glomerular filtration rate, calculated using creatinine and urea clearance. The secondary endpoints are serial changes of glomerular filtration rate and daily urine volume, changes of serum middle molecule concentrations, hospitalization, mortality, and patient reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCO group | Experimental | Device: Theranova 400 dialyzerHemodialysis using Theranova 400 dialyzer |
| High-flux group | Active comparator | Device: High-flux dialyzerHemodialysis using high-flux dialyzer (Fx CorDiax 80; Fresenius Medical Care) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Incident end-stage renal disease ESRD patient receiving hemodialysis for less than 1 month
- 18 years old and older
- Creatinine clearance of more than 2 ml/min
- Agreement to participate in the clinical study
- Vascular access by arteriovenous fistula/graft
Key exclusion criteria (8 listed)
- Plan for kidney transplantation within 6 months
- Severe volume overloading state
- Dialysis through permanent catheter
- Any hematologic malignancy or monoclonal gammopathy
- Any malignancy
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 |
|---|---|---|
| Theranova 400 dialyzerHemodialysis using Theranova 400 dialyzer | Device | MCO group |
| High-flux dialyzerAlso: Fx CorDiax 80 dialyzerHemodialysis using high-flux dialyzer | Device | High-flux group |
Primary outcome
Change of glomerular filtration rate
Time frame: Between baseline and 12 months
Glomerular filtration rate is calculated as the mean of creatinine and urea clearance adjusted for body surface area. The outcome refers to the mean difference of glomerular filtration rate between baseline and after 12 months.
11 secondary outcomes
Change of glomerular filtration rate
Time frame: 0, 3, 6, 9, 12 months
Change of daily urine volume
Time frame: 0, 3, 6, 9, 12 months
Change and reduction ratio of inflammatory marker levels
Time frame: 0, 12 months
Change of hs-CRP
Time frame: 0, 12 months
Change of Beta 2-microglobulin
Time frame: 0, 12 months
Change of kidney injury markers
Time frame: 0, 12 months
Change of cystatin-C
Time frame: 0, 12 months
Change and reduction ratio of Kappa and lambda free light chains
Time frame: 0, 12 months
Hospitalization
Time frame: Through 12-month study duration
Mortality
Time frame: Through 12-month study duration
Patient-reported outcome
Time frame: 0, 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 21 Nov 2023.
- Background: PubMed 27587605Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.
- Derived from this study: PubMed 40036081Lim JH, Seo YJ, Jeon Y, Jeon YH, Jung HY, Choi JY, Park SH, Kim CD, Kang SH, Ryu JH, Kang DH, Cho JH, Kim YL. Expanded Hemodialysis with Theranova Dialyzer and Residual Kidney Function in Patients Starting Long-Term Hemodialysis: A Randomized Controlled Trial. J Am Soc Nephrol. 2025 Mar 4;36(8):1614-1625. doi: 10.1681/ASN.0000000655.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theranova 400 dialyzer and High-flux dialyzer in people with End Stage Renal Disease, run by Kyungpook National University Hospital at 1 site in South Korea.
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 5 inclusion and 8 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 21 Nov 2023. 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 South Korea. 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?
Change of glomerular filtration rate (time frame: Between baseline and 12 months). 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 NCT04211571, which also lists 2 linked publications.
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 21 Nov 2023.