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 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.

Study Overview

• Status: Completed
• Conditions: End-Stage Renal Disease
• Intervention / Treatment: Device: Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line; Device: AK200 Ultra S, extracorporeal circulation conduct of blood purification

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Reduction ratio of β2-Microglobulin during and after Dialysis		Day 1 (One Midweek HDF Treament Session, 4 hour duration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Urea Reduction Ratio (URR) during and after Dialysis		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."	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."	Day 1 (One Midweek HDF Treament Session, 4 hour duration)

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2019
• Primary Completion (Actual): November 9, 2019
• Study Completion (Actual): November 9, 2019

Study Registration Dates

• First Submitted: February 28, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 5, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: BXU012184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No