End-Stage Renal DiseaseNCT03859830

Clinical Observation of the Performance of Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line in Treatments of Patients With End-Stage Renal Disease (ESRD)

A study testing Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line and AK200 Ultra S, extracorporeal circulation conduct of blood purification in people with End-Stage Renal Disease, run by Vantive Health LLC at 7 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

The incidence and prevalence of chronic kidney disease are increasing worldwide, as is the number of patients progressing to End-Stage Renal Disease (ESRD). China has experienced an increased accessibility and affordability of dialysis treatment, which in turn has brought about an increase in the number of patients… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: End-Stage Renal Disease
What is being tested?: Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line and AK200 Ultra S, extracorporeal circulation conduct of blood purification
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 276 participants
Where: 7 sitesChina
Study dates: 22 Jan 2019to 9 Nov 2019
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients ≥18 to ≤75 years of age with diagnosis of ESRD
Patients on thrice weekly HD for a minimum of 3 months who received at least one 4 hour HDF treatment in the past two weeks prior to study enrollment with a total convection volume (VCtot) (including UF) of equal or greater than 16 L post-dilution
Body weight (BW) ≥ 40 Kg
Patients with stable dialysis profiles:
Kt/Vurea ≥ 1.2 which is taken within 4 weeks before study enrollment
Dialysis prescription stable over 6 recent treatments

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Patients on stable anticoagulation dose
Patients who have an adequate arteriovenous fistula (AVF) or graft, capable of providing a QB with 200-300 mL/min range
Patients able to give informed consent (IC) after an explanation of the proposed study
Patients who receive in-center treatment HD at a site that routinely implements high flux dialysis and/or HDF

Who cannot join

Patients who are human immunodeficiency virus (HIV) positive, or with active Hepatitis A (HAV), Hepatitis B (HBV) or Hepatitis C (HBC)
Patients with known hemodynamic instability, bleeding risks and coagulation disorders
Patients with active or ongoing infection
Patients with advanced liver, heart or pulmonary disease, as judged by the Investigator, that would not be suitable for participation in the study
Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator
Patients who are currently participating in other interventional clinical trials or have participated in another interventional clinical trial within one (1) month of the current study that may interfere with this study as judged by the Investigator.

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Pregnant women, lactating women and women or men who plan to have a baby and refuse to apply the effective contraceptive methods during the study period
Patients with active cancer
Patients who have acute renal failure
Patients who are pre-scheduled for a living kidney transplant within the next two months, who plan a change to PD within the next two months, or who require single needle dialysis therapy
Patients diagnosed with New York Heart Association (NYHA) Class IV congestive heart failure, or acute coronary syndrome and/or who have suffered a myocardial infarction within the three months prior to the start of the study
Patients with a history of severe mental disorders
Patients who have had an allergic response to polyarylethersulfone or polysulfone membrane

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

China7 sites

Investigational Site
Beijing, Beijing Municipality, 100730
Investigational Site
Foshan, Guangdong, 528000
Investigational Site
Hangzhou, Zhejiang, 310003
Investigational Site
Nanjing, Jiangsu, 210009
Investigational Site
Shenyang, Liaoning, 110001
Investigational Site
Wenzhou, Zhejiang, 325003
Investigational Site
Wuhan, Hubei, 430060

Other trials in China

About this study

The scope of the trial is to observe the performance of Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line versus AK 200 Ultra S, extracorporeal circulation conduct of blood purification apparatus and Ultra Steriset as the comparator devices in treatment of patients using hemodialysis (HD) or hemodiafiltration (HDF) for ESRD.

Conditions: End-Stage Renal Disease
Being tested: Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line, AK200 Ultra S, extracorporeal circulation conduct of blood purification
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.

Artis Dialysis System, ArtiSet PrePost and Ultra HDF LineDevice
The HDF session will be performed in post-dilution volume-controlled mode, with a minimum target total convective volume (VCtot) of 16 L and blood flow rate (QB) set at 200-300 mL/min.
AK200 Ultra S, extracorporeal circulation conduct of blood purificationDevice
The HDF session will be performed in post-dilution volume-controlled mode, with a minimum target total convective volume (VCtot) of 16 L and blood flow rate (QB) set at 200-300 mL/min.

Study groups in NCT03859830
Study group	Role	What they receive
Artis Dialysis System	Experimental	One midweek HDF session for a duration of 4 hours. Receives: Device: Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line
AK200 Ultra S	Active comparator	One midweek HDF session for a duration of 4 hours. Receives: Device: AK200 Ultra S, extracorporeal circulation conduct of blood purification

What is being measured

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

Number of participants successfully completing HDF without interruption of therapy during Dialysis
Defined as participants not having an interruption in therapy for greater than 15 continuous minutes due to a technical reason of all the enrolled patients in the same group. If there is more than one interruption due to technical reasons, the criteria for failure should be the sum of all interruptions being greater than 15 minutes.
Measured: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Number of Participants by Level of Effectiveness of Disposable Tubing during and after Dialysis
Participant recorded as "yes" or "no" by categories of (1) blood flow in the tubing is smooth without obstruction, blood flow rate meets requirement of the patient's hemodialysis prescription and finish the dialysis procedure, the (2) connections are free from blood and air leakage and detachment, (3) there is no folding, cracking or rupture in tubing during dialysis procedure.
Measured: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Reduction ratio of β2-Microglobulin during and after Dialysis
Measured: Day 1 (One Midweek HDF Treament Session, 4 hour duration)

Secondary outcomes (4)

Single-pool Kt/V urea during and after Dialysis
Computing formula: spKt/V = -ln (R - 0.008t) + (4 - 3.5R) x (ΔBW/BW). Where R is the blood urea after hemodialysis/ blood urea before hemodialysis; t is time in hours; ΔBW is the weight change values after hemodialysis, namely ultrafiltration volume in liters; BW is weight in kilograms.
Measured: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Urea Reduction Ratio (URR) during and after Dialysis
Measured: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Number of Participants by Level of Appearance of Disposable Tubing during and after Dialysis
Participants with tubing as flexible, transparent, and smooth (it is easy to observe the presence of bubbles) recorded categorically as "yes" or "no."
Measured: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Number of Participants by Level of Elasticity of Pump Lines during and after Dialysis
Participants with the blood and fluid lines showing good elasticity and good resilience after being rolled without obvious deformity after dialysis recorded categorically as "yes" or "no."
Measured: Day 1 (One Midweek HDF Treament Session, 4 hour duration)

Timeline

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

22 Jan 20199 Nov 2019

First posted1 Mar 2019
Study start22 Jan 2019
Primary completion9 Nov 2019
Study completion9 Nov 2019

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: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03859830
Sponsor's protocol ID: BXU012184
Status last verified: Mar 2025
First submitted: 28 Feb 2019
Last updated: 13 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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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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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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: Clinical Observation of the Performance of Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line in Treatments of Patients With End-Stage Renal Disease (ESRD)
ClinicalTrials.gov ID: NCT03859830
Acronym / sponsor ID: BXU012184
Conditions: End-Stage Renal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: Vantive Health LLCIndustry (pharma, biotech, devices)
Collaborators: Baxter Healthcare Corporation
Study start: 22 Jan 2019 (actual)
Primary completion: 9 Nov 2019 (actual)
Study completion: 9 Nov 2019 (actual)
First posted: 1 Mar 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Artis Dialysis System	Experimental	Device: Artis Dialysis System, ArtiSet PrePost and Ultra HDF LineOne midweek HDF session for a duration of 4 hours.
AK200 Ultra S	Active comparator	Device: AK200 Ultra S, extracorporeal circulation conduct of blood purificationOne midweek HDF session for a duration of 4 hours.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patients ≥18 to ≤75 years of age with diagnosis of ESRD
Patients on thrice weekly HD for a minimum of 3 months who received at least one 4 hour HDF treatment in the past two weeks prior to study enrollment with a total convection volume (VCtot) (including UF) of equal or greater than 16 L post-dilution
Body weight (BW) ≥ 40 Kg
Patients with stable dialysis profiles:
Patients on stable anticoagulation dose

Key exclusion criteria (13 listed)

Patients who are human immunodeficiency virus (HIV) positive, or with active Hepatitis A (HAV), Hepatitis B (HBV) or Hepatitis C (HBC)
Patients with known hemodynamic instability, bleeding risks and coagulation disorders
Patients with active or ongoing infection
Patients with advanced liver, heart or pulmonary disease, as judged by the Investigator, that would not be suitable for participation in the study
Patients with any comorbidity possibly conflicting with the study purpose or procedures as judged by the Investigator

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
Artis Dialysis System, ArtiSet PrePost and Ultra HDF LineThe HDF session will be performed in post-dilution volume-controlled mode, with a minimum target total convective volume (VCtot) of 16 L and blood flow rate (QB) set at 200-300 mL/min.	Device	Artis Dialysis System
AK200 Ultra S, extracorporeal circulation conduct of blood purificationThe HDF session will be performed in post-dilution volume-controlled mode, with a minimum target total convective volume (VCtot) of 16 L and blood flow rate (QB) set at 200-300 mL/min.	Device	AK200 Ultra S

Primary outcome

Number of participants successfully completing HDF without interruption of therapy during Dialysis
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Defined as participants not having an interruption in therapy for greater than 15 continuous minutes due to a technical reason of all the enrolled patients in the same group. If there is more than one interruption due to technical reasons, the criteria for failure should be the sum of all interruptions being greater than 15 minutes.
Number of Participants by Level of Effectiveness of Disposable Tubing during and after Dialysis
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Participant recorded as "yes" or "no" by categories of (1) blood flow in the tubing is smooth without obstruction, blood flow rate meets requirement of the patient's hemodialysis prescription and finish the dialysis procedure, the (2) connections are free from blood and air leakage and detachment, (3) there is no folding, cracking or rupture in tubing during dialysis procedure.
Reduction ratio of β2-Microglobulin during and after Dialysis
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)

4 secondary outcomes

Single-pool Kt/V urea during and after Dialysis
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Urea Reduction Ratio (URR) during and after Dialysis
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Number of Participants by Level of Appearance of Disposable Tubing during and after Dialysis
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Number of Participants by Level of Elasticity of Pump Lines during and after Dialysis
Time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)

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.
Individual participant dataSharing planned: No

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
Chronic Kidney Failure, Chronic Kidney Diseases
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
End Stage Renal Disease on Dialysis, Adult

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.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 13 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 7 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?

Number of participants successfully completing HDF without interruption of therapy during Dialysis (time frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)). 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 NCT03859830.

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.