Kidney Failure, ChronicCARTOONNCT03448887
Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration
A study testing Theranova and Online hemodiafiltration in people with Kidney Failure, Chronic and Renal Dialysis, run by Seoul National University Hospital at 4 sites in South Korea.
Trial summary
Theranova is a novel medium cut-off (MCO) dialyzer. Previous studies identified that theranova dialyzer had superior performance on middle molecule removal to conventional hemodialysis (HD) and hemodiafiltration (HDF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Renal Dialysis
- What is being tested?
- Theranova and Online hemodiafiltration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 15 Mar 2018to 31 Aug 2020
- 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
- 18 years old and older
- Hemodialysis more than 3 months because of end-stage renal disease
- Consent to the study protocol
Who cannot join
- Already receiving online hemodiafiltration before study enrollment
- Dialysis schedule other than three times per week (e.g., once per week)
- Receiving concurrent peritoneal dialysis
- Having a plan to receive kidney transplantation within 1 year
- Having multiple myeloma or monoclonal gammopathy
- Having advanced or active malignancy
- Having a plan to be pregnant or being pregnant / breast-feeding or not having a plan to use contraception
- Participating in other clinical trials
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Seoul National University Bundang Hospital
Gyeonggi-do, 13620
Seoul National University Hospital
Seoul, 03080
Samsung Medical Center
Seoul, 06351
Seoul St. Mary's Hospital
Seoul, 06591
About this study
Official title: Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration - Exploratory, Multicenter, Randomized Clinical Trial
Theranova is a novel medium cut-off (MCO) dialyzer. Previous studies identified that theranova dialyzer had superior performance on middle molecule removal to conventional hemodialysis (HD) and hemodiafiltration (HDF). The present study addresses to compare clinical outcomes including cardiovascular endpoint between HD with theranova dialyzer and HDF.
Read the detailed description
While conventional hemodialysis (HD) modality effectively removes small-sized molecules, performance with middle-sized and protein-bound molecules is not well established. With increasing perception on importance of middle molecule removal, on-line hemodiafiltration (HDF) is getting more attention from healthcare professionals. However, HDF has not been widely used in Korea due to its technical burden and limited public funding issue.
Novel medium cut-off (MCO) dialyzer, Theranova, is available in Korea, which showed superior performance on middle molecule removal to conventional HD and HDF from the previous study. This new dialyzer can be a good alternative option replacing conventional HD or even HDF with its benefits. However, current data available on the MCP dialyzer has certain limitations such as small sample size, no Asian subject included, limited types of biomarkers, and no clinical outcomes (particularly cardiovascular diseases) included.
With this respect, performance comparison of MCO dialyzer with HDF in terms of clinical outcomes, including cardiovascular endpoint would fill the exiting data gap, which is absolutely important to make a clinical decision on dialysis modality.
- Conditions
- Kidney Failure, Chronic, Renal Dialysis
- Being tested
- Theranova, Online hemodiafiltration
- Keywords
- End-stage renal disease, Medium cut-off dialyzer, Hemodiafiltration, Cardiovascular, Pulse wave velocity
- 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.
TheranovaDevice
Extended HD with theranova
Online hemodiafiltrationDevice
Online hemodiafiltration
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Extended HD with MCO dialyzer Receives: Device: Theranova |
| Control group | Active comparator | Online hemodiafiltration Receives: Device: Online hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiovascular surrogate marker
Brachial-ankle pulse wave velocity (m/s)
Measured: 0, 6, 12 months
Secondary outcomes (11)
Change in cardiac surrogate marker #1
CT coronary calcium scoring (score)
Measured: 0, 6, 12 months
Change in cardiac surrogate marker #2
Echocardiography: ejection fraction (%); E/e' ratio (cm/s per cm/s); LVMI (g/m2).
Measured: 0, 6, 12 months
Change in cardiovascular biomarkers #1
Plasma levels of BNP (pg/ml)
Measured: 0, 6, 12 months
Change in cardiovascular biomarkers #2
Plasma levels of NT-proBNP (pg/ml)
Measured: 0, 6, 12 months
Change in cardiovascular biomarkers #3
Plasma levels of hsCRP (mg/dl)
Measured: 0, 6, 12 months
Change in cardiovascular biomarkers #4
Plasma levels of troponin-I (ng/ml)
Measured: 0, 6, 12 months
Change in cardiovascular biomarkers #5
Plasma levels of troponin-T (ng/ml)
Measured: 0, 6, 12 months
Change in cardiovascular biomarkers #6
Plasma levels of IL-6 (pg/ml)
Measured: 0, 6, 12 months
Patient-reported outcomes #1
Dialysis symptom index (score)
Measured: 0, 6, 12 months
Patient-reported outcomes #2
Degree of fatigue after dialysis (scale from 0 to 10)
Measured: 0, 6, 12 months
Patient-reported outcomes #3
Post-dialysis recovery time (within minutes, when arriving home, at bed time, next morning, by next dialysis)
Measured: 0, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start15 Mar 2018
- Primary completion15 Jul 2020
- Study completion31 Aug 2020
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 Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Model description
- Exploratory, Multicenter, Randomized
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Kwon wook Joo, Seoul National University Hospital
- Investigators
- Kwon Wook Joo, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448887
- Sponsor's protocol ID
- Theranova-SNU-01
- Acronym
- CARTOON
- Status last verified
- Oct 2020
- First submitted
- 16 Feb 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- 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 27587605
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Risk Comparison Between Expanded Hemodialysis Using Theranova and On-line Hemodiafiltration - Exploratory, Multicenter, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03448887
- Acronym / sponsor ID
- CARTOON / Theranova-SNU-01
- Conditions
- Kidney Failure, Chronic, Renal Dialysis
- Keywords
- End-stage renal disease, Medium cut-off dialyzer, Hemodiafiltration, Cardiovascular, Pulse wave velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Seoul St. Mary's Hospital, Seoul National University Bundang Hospital, Baxter Healthcare Corporation
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 28 Feb 2018 (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 (MCO) dialyzer. Previous studies identified that theranova dialyzer had superior performance on middle molecule removal to conventional hemodialysis (HD) and hemodiafiltration (HDF). The present study addresses to compare clinical outcomes including cardiovascular endpoint between HD with theranova dialyzer and HDF.
Detailed description
While conventional hemodialysis (HD) modality effectively removes small-sized molecules, performance with middle-sized and protein-bound molecules is not well established. With increasing perception on importance of middle molecule removal, on-line hemodiafiltration (HDF) is getting more attention from healthcare professionals. However, HDF has not been widely used in Korea due to its technical burden and limited public funding issue.
Novel medium cut-off (MCO) dialyzer, Theranova, is available in Korea, which showed superior performance on middle molecule removal to conventional HD and HDF from the previous study. This new dialyzer can be a good alternative option replacing conventional HD or even HDF with its benefits. However, current data available on the MCP dialyzer has certain limitations such as small sample size, no Asian subject included, limited types of biomarkers, and no clinical outcomes (particularly cardiovascular diseases) included.
With this respect, performance comparison of MCO dialyzer with HDF in terms of clinical outcomes, including cardiovascular endpoint would fill the exiting data gap, which is absolutely important to make a clinical decision on dialysis modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Exploratory, Multicenter, Randomized
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: TheranovaExtended HD with MCO dialyzer |
| Control group | Active comparator | Device: Online hemodiafiltrationOnline hemodiafiltration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old and older
- Hemodialysis more than 3 months because of end-stage renal disease
- Consent to the study protocol
Key exclusion criteria (8 listed)
- Already receiving online hemodiafiltration before study enrollment
- Dialysis schedule other than three times per week (e.g., once per week)
- Receiving concurrent peritoneal dialysis
- Having a plan to receive kidney transplantation within 1 year
- Having multiple myeloma or monoclonal gammopathy
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 |
|---|---|---|
| TheranovaExtended HD with theranova | Device | Study group |
| Online hemodiafiltrationOnline hemodiafiltration | Device | Control group |
Primary outcome
Change in cardiovascular surrogate marker
Time frame: 0, 6, 12 months
Brachial-ankle pulse wave velocity (m/s)
11 secondary outcomes
Change in cardiac surrogate marker #1
Time frame: 0, 6, 12 months
Change in cardiac surrogate marker #2
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #1
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #2
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #3
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #4
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #5
Time frame: 0, 6, 12 months
Change in cardiovascular biomarkers #6
Time frame: 0, 6, 12 months
Patient-reported outcomes #1
Time frame: 0, 6, 12 months
Patient-reported outcomes #2
Time frame: 0, 6, 12 months
Patient-reported outcomes #3
Time frame: 0, 6, 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 8 Oct 2020.
- Results publication: 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.
- 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.
Kwon Wook Joo, MD, PhD principal investigator
Seoul National University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theranova and Online hemodiafiltration in people with Kidney Failure, Chronic and Renal Dialysis, run by Seoul National University Hospital at 4 sites 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 3 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 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 in cardiovascular surrogate marker (time frame: 0, 6, 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 NCT03448887, 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 8 Oct 2020.