Chronic Kidney FailureROCKetNCT05309291
Theranova Randomized, Controlled, Trial (RCT) in China
A study testing Theranova 400 Dialyzer and FX 800 Dialyzer in people with Chronic Kidney Failure and Acute Kidney Failure, run by Vantive Health LLC at 10 sites in China.
Trial summary
Traditional hemodialysis (HD) therapy is very effective in clearing urea and smaller middle molecules, but is limited in clearing larger middle molecules. These accumulated large middle-molecular-weight uremic toxins may cause and aggravate inflammation, atherosclerosis and calcification, which can indirectly lead to… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Failure, Acute Kidney Failure
- What is being tested?
- Theranova 400 Dialyzer and FX 800 Dialyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 10 sitesChina
- Study dates
- 22 Jun 2022to 6 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years old and ≤80 years old, regardless of gender;
- Patients who are able to sign informed consent form (ICF) after an explanation of the proposed study;
- Patients who receive in-center HD treatment at a site that routinely implements high flux dialysis and HDF;
- Patients who have been stable receiving in-center HD/HDF for >3 months prior to study enrollment;
- Patients with kidney failure receiving maintained HD treatment with a history of thrice weekly HD, and at least 1 HDF session within 1 month prior to the study shall be judged by the investigator;
- Patients who have an adequate arteriovenous (AV) fistula or graft, or dual-lumen tunneled catheter capable of providing a blood flow rate (QB) of at least 250 mL/min;
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- Patients have no changes in dialysis prescription (dialyzer, time, dialysis fluid flow rate (QD), QB, sufficient dialysis anticoagulation, and stable prescribed doses) over last 6 treatments as judged by the investigator. The dialysis treatment time should be 3.5 to 4.5 hours per session with minimum QB of 250 mL/min and QD of 500 mL/min;
- Patients with a minimum total convective volume (including ultrafiltration (UF)) of 16 L post-dilution for the most recent HDF treatment;
- Patients who have Kt/Vurea > 1.2 for the last 2 measurements, with the most recent Kt/Vurea measurement taken within 4 weeks before or during study screening.
Who cannot join
- Patients who have acute kidney injury with the chance for recovery;
- Pregnant and lactating women;
- Patients diagnosed with a New York Heart Association (NYHA) Class IV congestive heart failure, or acute coronary syndrome, and/or who have suffered a myocardial infarction within 3 months prior to the start of the study;
- Patients with known hemodynamic instability, anemia (hemoglobin <90 g/L), and/or patients with hemoglobin >130g/L for coagulation risk;
- Patients with active or ongoing infection as per investigator's judgement (e.g C-reactive protein [CRP] level more than 5 folds of normal);
- Patients who are severely malnourished or with significant disease that interferes with liver synthetic function ( e.g. with serum albumin <30 g/L);
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- Patients with positive serology tests for Hepatitis B surface antigen, Hepatitis C total antibody, and advanced liver, or pulmonary disease as judged by the investigator;
- Patients with positive serology tests for human immunodeficiency virus (HIV), Syphilis;
- Patients receiving immunosuppressive treatment or with autoimmune disease;
- Patients with a history of solid tumors requiring anti-cancer therapy in the past or next 6 months, or with a life expectancy of <1 year, or patients with history of hematology neoplasm;
- Patients who are pre-scheduled for a living donor kidney transplant within the next 1 year, who plan a change to peritoneal dialysis (PD) within the next 1 year, or who require single-needle dialysis therapy;
- Patients who have had an allergic response to polyarylethersulfone (PAES) or polysulfone (PS) membrane or have history of poor tolerance to dialyzers with synthetic membranes;
- Patients with a history of severe mental disorders who are unable to provide consent or comply with study procedures as assessed by the investigator;
- Patients who are currently participating in or have previously participated in other interventional clinical studies during the past 30 days;
- Patients with any comorbidity possibly conflicting with the study as judged by the investigator.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Investigational Site
Beijing, 100013
Investigational Site
Beijing, 100034
Investigational Site
Dalian, 116001
Investigational Site
Dalian, 116011
Investigational Site
Hangzhou, 310014
Investigational Site
Nanjing, 210002
Investigational Site
Shanghai, 200011
Investigational Site
Shanghai, 200127
Investigational Site
Shenzhen, 518020
Investigational Site
Suzhou, 215006
About this study
Official title: A Randomized, Open-label, Controlled, Parallel, Multicenter Study in Kidney Failure Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration
Traditional hemodialysis (HD) therapy is very effective in clearing urea and smaller middle molecules, but is limited in clearing larger middle molecules. These accumulated large middle-molecular-weight uremic toxins may cause and aggravate inflammation, atherosclerosis and calcification, which can indirectly lead to the death of patients. Studies have shown that, compared to conventional high-flux HD (HF-HD), hemodiafiltration (HDF) that combines diffusion and convection can reduce the all-cause mortality. Compared to the conventional HF-HD, HDF can more effectively clear larger molecular toxins in one session, which may be related to the better clearance effect of HDF on middle-molecular-weight toxins
Theranova's innovative Medium Cut-Off® membranes has high permeability and selectivity to uremic toxins (clearance of a molecular weight of up to 45 kDa) and can retain essential proteins, to maintain patient's albumin level during the HD treatment[9]. Its unique membrane and high cut-off characteristics expand the clearance range beyond those of flux membrane dialyzers. Theranova 400 can be widely used in most blood purification centers under conventional HD equipment and treatment modes, with the effect similar to HDF This study is to demonstrate non-inferiority of the Theranova 400 Dialyzer in HD mode (hereinafter referred to as Theranova 400) compared to HDF, using FX 800 in HDF mode (hereinafter referred to as FX 800).
- Conditions
- Chronic Kidney Failure, Acute Kidney Failure
- Being tested
- Theranova 400 Dialyzer, FX 800 Dialyzer
- Medical subject headings
- Kidney Failure, Chronic, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theranova 400 DialyzerDevice
Also called Hollow fiber dialyzers with medium cut-off membrane
Dialysis performed in HD mode.
FX 800 DialyzerDevice
Also called Hollow fiber hemodialysis filter
Dialysis performed in HDF mode.
| Study group | Role | What they receive |
|---|---|---|
| Theranova 400 Dialyzer | Experimental | 1 week, 1 session in mid-week HD therapy. Pre dialysis blood samples taken from fistula needle or central venous catheter. Post dialysis blood samples taken from arterial sampling port of bloodline Receives: Device: Theranova 400 Dialyzer |
| FX 800 Dialyzer | Active comparator | 1 week, 1 session in mid-week HDF therapy. Pre dialysis blood samples taken from fistula needle or central venous catheter. Post dialysis blood samples taken from arterial sampling port of bloodline Receives: Device: FX 800 Dialyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction Ratio (RR) of Lambda Free Light Chains (λ FLC)
One mid-week treatment day dialysis session, pre-dialysis and post-dialysis. The RR was calculated using the following formula:
[(Cpre-Cpost)/Cpre], where Cpre and Cpost were the arterial plasma concentrations of λ FLC measured pre- and post- the mid-week dialysis session, respectively
Measured: Assessed at the mid-week treatment day dialysis session
Reduction Ratio of Beta-2 Microglobulin (β2-MG)
One mid-week treatment day dialysis session, pre-dialysis and post-dialysis. The RR was calculated using the following formula:
[(Cpre-Cpost)/Cpre], where Cpre and Cpost were the arterial plasma β2-MG concentrations measured pre- and post- the mid-week dialysis session, respectively.
Measured: Assessed at the mid-week treatment day dialysis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start22 Jun 2022
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Kidney FailureStudies 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
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05309291
- Sponsor's protocol ID
- BXU561424
- Acronym
- ROCKet
- Status last verified
- Jul 2025
- First submitted
- 25 Mar 2022
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of Clinical Trial Data: Sponsor is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, the Sponsor will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Controlled, Parallel, Multicenter Study in Kidney Failure Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration
- ClinicalTrials.gov ID
- NCT05309291
- Acronym / sponsor ID
- ROCKet / BXU561424
- Conditions
- Chronic Kidney Failure, Acute Kidney Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 22 Jun 2022 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Traditional hemodialysis (HD) therapy is very effective in clearing urea and smaller middle molecules, but is limited in clearing larger middle molecules. These accumulated large middle-molecular-weight uremic toxins may cause and aggravate inflammation, atherosclerosis and calcification, which can indirectly lead to the death of patients. Studies have shown that, compared to conventional high-flux HD (HF-HD), hemodiafiltration (HDF) that combines diffusion and convection can reduce the all-cause mortality. Compared to the conventional HF-HD, HDF can more effectively clear larger molecular toxins in one session, which may be related to the better clearance effect of HDF on middle-molecular-weight toxins
Theranova's innovative Medium Cut-Off® membranes has high permeability and selectivity to uremic toxins (clearance of a molecular weight of up to 45 kDa) and can retain essential proteins, to maintain patient's albumin level during the HD treatment[9]. Its unique membrane and high cut-off characteristics expand the clearance range beyond those of flux membrane dialyzers. Theranova 400 can be widely used in most blood purification centers under conventional HD equipment and treatment modes, with the effect similar to HDF This study is to demonstrate non-inferiority of the Theranova 400 Dialyzer in HD mode (hereinafter referred to as Theranova 400) compared to HDF, using FX 800 in HDF mode (hereinafter referred to as FX 800).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theranova 400 Dialyzer | Experimental | Device: Theranova 400 Dialyzer1 week, 1 session in mid-week HD therapy. Pre dialysis blood samples taken from fistula needle or central venous catheter. Post dialysis blood samples taken from arterial sampling port of bloodline |
| FX 800 Dialyzer | Active comparator | Device: FX 800 Dialyzer1 week, 1 session in mid-week HDF therapy. Pre dialysis blood samples taken from fistula needle or central venous catheter. Post dialysis blood samples taken from arterial sampling port of bloodline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged ≥18 years old and ≤80 years old, regardless of gender;
- Patients who are able to sign informed consent form (ICF) after an explanation of the proposed study;
- Patients who receive in-center HD treatment at a site that routinely implements high flux dialysis and HDF;
- Patients who have been stable receiving in-center HD/HDF for >3 months prior to study enrollment;
- Patients with kidney failure receiving maintained HD treatment with a history of thrice weekly HD, and at least 1 HDF session within 1 month prior to the study shall be judged by the investigator;
Key exclusion criteria (15 listed)
- Patients who have acute kidney injury with the chance for recovery;
- Pregnant and lactating women;
- Patients diagnosed with a New York Heart Association (NYHA) Class IV congestive heart failure, or acute coronary syndrome, and/or who have suffered a myocardial infarction within 3 months prior to the start of the study;
- Patients with known hemodynamic instability, anemia (hemoglobin <90 g/L), and/or patients with hemoglobin >130g/L for coagulation risk;
- Patients with active or ongoing infection as per investigator's judgement (e.g C-reactive protein [CRP] level more than 5 folds of normal);
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 DialyzerAlso: Hollow fiber dialyzers with medium cut-off membraneDialysis performed in HD mode. | Device | Theranova 400 Dialyzer |
| FX 800 DialyzerAlso: Hollow fiber hemodialysis filterDialysis performed in HDF mode. | Device | FX 800 Dialyzer |
Primary outcome
Reduction Ratio (RR) of Lambda Free Light Chains (λ FLC)
Time frame: Assessed at the mid-week treatment day dialysis session
One mid-week treatment day dialysis session, pre-dialysis and post-dialysis. The RR was calculated using the following formula: [(Cpre-Cpost)/Cpre], where Cpre and Cpost were the arterial plasma concentrations of λ FLC measured pre- and post- the mid-week dialysis session, respectively
Reduction Ratio of Beta-2 Microglobulin (β2-MG)
Time frame: Assessed at the mid-week treatment day dialysis session
One mid-week treatment day dialysis session, pre-dialysis and post-dialysis. The RR was calculated using the following formula: [(Cpre-Cpost)/Cpre], where Cpre and Cpost were the arterial plasma β2-MG concentrations measured pre- and post- the mid-week dialysis session, respectively.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Sharing of Clinical Trial Data: Sponsor is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, the Sponsor will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)
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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.
10 sites 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 FX 800 Dialyzer in people with Chronic Kidney Failure and Acute Kidney Failure, run by Vantive Health LLC at 10 sites in China.
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 9 inclusion and 15 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 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction Ratio (RR) of Lambda Free Light Chains (λ FLC) (time frame: Assessed at the mid-week treatment day dialysis session). 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?
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 14 Jul 2025.