End Stage Renal DiseaseNCT03547336

Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration

A study testing Theranova 400 Dialyzer and FX800 Dialyzer in people with End Stage Renal Disease, run by Vantive Health LLC at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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 FX800 Dialyzer
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 212 participants
Where: 8 sitesChina
Study dates: 29 Jun 2018to 4 Jan 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

Patients aged 18 years or older.
Patients who are able to give IC after an explanation of the proposed study.
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.
Patients with a dialysis prescription (dialyzer, time, dialysis fluid flow rate (QD), blood flow rate (QB)) stable over 6 recent treatments. The dialysis treatment time should be 3.5 to 4.5 hours per session with minimum QB of at least 250 mL/min and QD of 500 mL/min.
Patients who are on stable anticoagulation prescription and dose.
Patients with ESRD receiving chronic HD treatment with a history of thrice weekly HD, and at least 1 HDF session within 1 month prior to study.

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Patients who have been stable on in-center HD for >3 months prior to study enrollment
Patients who have an adequate arteriovenous (AV) fistula or graft, or dual-lumen tunneled catheter capable of providing a blood flow rate of at least 250 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 receive in-center treatment hemodialysis at a site that routinely implements high flux dialysis and HDF.

Who cannot join

Patients who have acute renal failure with the chance for recovery.
Patients who are pre-scheduled for a living donor kidney transplant within the next six months, who plan a change to PD within the next six months, or who require single-needle dialysis therapy.
Pregnant and lactating women.
Patients with positive serology tests for Hepatitis B surface antigen, Hepatitis C total antibody), HIV and Syphilis.
Patients with known hemodynamic instability, anemia (Hgb < 90 g/L), and/or patients with Hgb >130g/L for coagulation risk.
Patients who are severely malnourished or with significant disease that interferes with liver synthetic function, e.g. with serum albumin <35 g/L.

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Patients with active or ongoing infection as per investigator's judgement.
Patients with history of solid tumors requiring anti-cancer therapy in the past or next 6 months, or life expectancy less than 1 year, or patients or with history of hematology neoplasm.
Patients diagnosed with a NYHA Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within three months prior to the start of the study.
Patients with a history of severe mental disorders.
Patients who are currently participating in, or have previously participated in other interventional clinical trials during the past 4 weeks.
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 advanced liver, heart or pulmonary disease as judged by the Investigator.
Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

China8 sites

Investigational Site
Beijing, 100034
Investigational Site
Chengdu, Sichuan, 610041
Investigational Site
Guangzhou, Guangdong, 510515
Investigational Site
Hangzhou, Zhejiang, 310014
Investigational Site
Hefei, Anhui, 230601
Investigational Site
Shanghai, Shanghai Municipality, 200011
Investigational Site
Wuhan, Hubei, 430060
Investigational Site
Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: A Randomized, Controlled, Open-label, Parallel Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration

In China, the estimated prevalence of patients with ESRD receiving PD or maintenance HD increased from 51.7 per million population (pmp) at the end of 2007 to 79.1 pmp at the end of 2008. Theranova 400 is designed to deliver the performance of hemodiafiltration (HDF) using standard hemodialysis (HD) equipment and treatment mode, including HD machines, disposables, blood and dialysate flows, length of treatment and frequency of treatment. Theranova 400 utilizes a Medium Cut-Off (MCO) membrane with extended permeability for middle solutes to closely modulate the removal function of the kidney without the complexity of HDF. The primary objective of the study is to demonstrate non-inferiority of the Theranova Dialyzer in hemodialysis (HD) mode compared to hemodiafiltration (HDF), using FX 800 in HDF mode. Comparison of the study arms over time will be used to support the safety of Theranova 400 by demonstrating stable serum albumin levels, as well as support the dialyzer's efficacy to significantly remove serum middle molecules.

Conditions: End Stage Renal Disease
Being tested: Theranova 400 Dialyzer, FX800 Dialyzer
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
Dialysis performed in HD mode. Treatment duration for each individual subject will vary based on clinical requirements determined by the Investigator, based on the subject's need, residual renal function, access function, tolerance to HD/HDF and other relevant factors. The participating subjects' HD/HDF prescriptions should be kept stable throughout the study.
FX800 DialyzerDevice
Dialysis performed in HDF mode. Treatment duration for each individual subject will vary based on clinical requirements determined by the Investigator, based on the subject's need, residual renal function, access function, tolerance to HD/HDF and other relevant factors. The participating subjects' HD/HDF prescriptions should be kept stable throughout the study.

Study groups in NCT03547336
Study group	Role	What they receive
Theranova 400 Dialyzer	Experimental	In-center hemodialysis (in HD mode), 3 times a week for 12 week duration. The patient will undergo regular HD treatment on the first treatment of the first week of study, after which, the patient will switch to the randomized dialyzer, from the second treatment to the end of study treatment. Blood sampling will be obtained at the hospital by trained personnel according to local routines. Receives: Device: Theranova 400 Dialyzer
FX800	Active comparator	In-center hemodialysis (in HDF mode), 3 times a week for 12 week duration. The patient will undergo regular HD treatment on the first treatment of the first week of study, after which, the patient will switch to the randomized dialyzer, from the second treatment to the end of study treatment. Blood sampling will be obtained at the hospital by trained personnel according to local routines. Receives: Device: FX800 Dialyzer

What is being measured

The primary outcome is the main question the study is designed to answer.

Reduction ratio of lambda free light chains (λ FLC)
At the first mid-week treatment day
Measured: Up to 1 week
Reduction ratio of β2 microglobulin
At the first mid-week treatment day
Measured: Up to 1 week
Pre-dialysis serum albumin
Measured: Study Completion (Week 12)

Secondary outcomes (9)

Kt/V urea
Mid-Week Treatment Day
Measured: Week 1, Week 5, Week 9, Week 13
Urea reduction ratio (URR)
Mid-Week Treatment Day
Measured: Week 1, Week 5, Week 9, Week 13
Pre-dialysis serum levels of λ FLC
Mid-Week Treatment Day
Measured: Week 1, Week 5, Week 9, Week 13
Pre-dialysis serum levels of β2 microglobulin
Mid-Week Treatment Day
Measured: Week 1, Week 5, Week 9, Week 13
Reduction ratio of α1 microglobulin (α1M)
At the first mid-week treatment day
Measured: Up to 1 week
Reduction ratio of Chitinase-3-like protein (YKL-40)
At the first mid-week treatment day
Measured: Up to 1 week
Reduction ratio of complement factor D (CFD)
At the first mid-week treatment day
Measured: Up to 1 week
Reduction ratio of myoglobin
At the first mid-week treatment day
Measured: Up to 1 week
Reduction ratio of kappa free light chains (κ FLC)
At the first mid-week treatment day
Measured: Up to 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jun 20184 Jan 2020

First posted6 Jun 2018
Study start29 Jun 2018
Primary completion4 Jan 2020
Study completion4 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: 212 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03547336
Sponsor's protocol ID: 7408001
Status last verified: Mar 2025
First submitted: 16 May 2018
Last updated: 13 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety and Efficacy of Empagliflozin in Hemodialysis
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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled, Open-label, Parallel Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis Comparing the Theranova Dialyzer to Hemodiafiltration
ClinicalTrials.gov ID: NCT03547336
Acronym / sponsor ID: 7408001
Conditions: End Stage Renal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 212 participants (actual)
Lead sponsor: Vantive Health LLCIndustry (pharma, biotech, devices)
Collaborators: Baxter Healthcare Corporation
Study start: 29 Jun 2018 (actual)
Primary completion: 4 Jan 2020 (actual)
Study completion: 4 Jan 2020 (actual)
First posted: 6 Jun 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.

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 DialyzerIn-center hemodialysis (in HD mode), 3 times a week for 12 week duration. The patient will undergo regular HD treatment on the first treatment of the first week of study, after which, the patient will switch to the randomized dialyzer, from the second treatment to the end of study treatment. Blood sampling will be obtained at the hospital by trained personnel according to local routines.
FX800	Active comparator	Device: FX800 DialyzerIn-center hemodialysis (in HDF mode), 3 times a week for 12 week duration. The patient will undergo regular HD treatment on the first treatment of the first week of study, after which, the patient will switch to the randomized dialyzer, from the second treatment to the end of study treatment. Blood sampling will be obtained at the hospital by trained personnel according to local routines.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patients aged 18 years or older.
Patients who are able to give IC after an explanation of the proposed study.
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.
Patients with a dialysis prescription (dialyzer, time, dialysis fluid flow rate (QD), blood flow rate (QB)) stable over 6 recent treatments. The dialysis treatment time should be 3.5 to 4.5 hours per session with minimum QB of at least 250 mL/min and QD of 500 mL/min.
Patients who are on stable anticoagulation prescription and dose.

Key exclusion criteria (14 listed)

Patients who have acute renal failure with the chance for recovery.
Patients who are pre-scheduled for a living donor kidney transplant within the next six months, who plan a change to PD within the next six months, or who require single-needle dialysis therapy.
Pregnant and lactating women.
Patients with positive serology tests for Hepatitis B surface antigen, Hepatitis C total antibody), HIV and Syphilis.
Patients with known hemodynamic instability, anemia (Hgb < 90 g/L), and/or patients with Hgb >130g/L for coagulation risk.

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 DialyzerDialysis performed in HD mode. Treatment duration for each individual subject will vary based on clinical requirements determined by the Investigator, based on the subject's need, residual renal function, access function, tolerance to HD/HDF and other relevant factors. The participating subjects' HD/HDF prescriptions should be kept stable throughout the study.	Device	Theranova 400 Dialyzer
FX800 DialyzerDialysis performed in HDF mode. Treatment duration for each individual subject will vary based on clinical requirements determined by the Investigator, based on the subject's need, residual renal function, access function, tolerance to HD/HDF and other relevant factors. The participating subjects' HD/HDF prescriptions should be kept stable throughout the study.	Device	FX800

Primary outcome

Reduction ratio of lambda free light chains (λ FLC)
Time frame: Up to 1 week
At the first mid-week treatment day
Reduction ratio of β2 microglobulin
Time frame: Up to 1 week
At the first mid-week treatment day
Pre-dialysis serum albumin
Time frame: Study Completion (Week 12)

9 secondary outcomes

Kt/V urea
Time frame: Week 1, Week 5, Week 9, Week 13
Urea reduction ratio (URR)
Time frame: Week 1, Week 5, Week 9, Week 13
Pre-dialysis serum levels of λ FLC
Time frame: Week 1, Week 5, Week 9, Week 13
Pre-dialysis serum levels of β2 microglobulin
Time frame: Week 1, Week 5, Week 9, Week 13
Reduction ratio of α1 microglobulin (α1M)
Time frame: Up to 1 week
Reduction ratio of Chitinase-3-like protein (YKL-40)
Time frame: Up to 1 week
Reduction ratio of complement factor D (CFD)
Time frame: Up to 1 week
Reduction ratio of myoglobin
Time frame: Up to 1 week
Reduction ratio of kappa free light chains (κ FLC)
Time frame: Up to 1 week

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 13 Mar 2025.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
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RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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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.

8 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 FX800 Dialyzer in people with End Stage Renal Disease, run by Vantive Health LLC at 8 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 10 inclusion and 14 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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

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?

Reduction ratio of lambda free light chains (λ FLC) (time frame: Up to 1 week). The study lists 3 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 NCT03547336.

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 13 Mar 2025.