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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859830
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Brief 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 receiving Renal Replacement Therapy (RRT).Without RRT, either in the form of maintenance dialysis or transplantation, ESRD is fatal.

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.


Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Device: Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line Device: AK200 Ultra S, extracorporeal circulation conduct of blood purification Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 22, 2019
Actual Primary Completion Date : November 9, 2019
Actual Study Completion Date : November 9, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Artis Dialysis System
One midweek HDF session for a duration of 4 hours.
Device: Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line
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.

Active Comparator: AK200 Ultra S
One midweek HDF session for a duration of 4 hours.
Device: AK200 Ultra S, extracorporeal circulation conduct of blood purification
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. Reduction ratio of β2-Microglobulin during and after Dialysis [ Time Frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration) ]

Secondary Outcome Measures :
  1. Single-pool Kt/V urea during and after Dialysis [ Time Frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration) ]
    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.

  2. Urea Reduction Ratio (URR) during and after Dialysis [ Time Frame: Day 1 (One Midweek HDF Treament Session, 4 hour duration) ]
  3. 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) ]
    Participants with tubing as flexible, transparent, and smooth (it is easy to observe the presence of bubbles) recorded categorically as "yes" or "no."

  4. 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) ]
    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."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. Kt/Vurea ≥ 1.2 which is taken within 4 weeks before study enrollment
    2. Dialysis prescription stable over 6 recent treatments
  • 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

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859830


Locations
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China, Beijing
Baxter Investigational Site
Beijing, Beijing, China, 100730
China, Guangdong
Baxter Investigational Site
Foshan, Guangdong, China, 528000
China, Hubei
Baxter Investigational Site
Wuhan, Hubei, China, 430060
China, Jiangsu
Baxter Investigational Site
Nanjing, Jiangsu, China, 210009
China, Liaoning
Baxter Investigational Site
Shenyang, Liaoning, China, 110001
China, Zhejiang
Baxter Investigational Site
Hangzhou, Zhejiang, China, 310003
Baxter Investigational Site
Wenzhou, Zhejiang, China, 325003
Sponsors and Collaborators
Baxter Healthcare Corporation
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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT03859830    
Other Study ID Numbers: BXU012184
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency