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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)

Primary Purpose

End-Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line

AK200 Ultra S, extracorporeal circulation conduct of blood purification

About this trial

This is an interventional treatment trial for End-Stage Renal Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Baxter Investigational Site
Baxter Investigational Site
Baxter Investigational Site
Baxter Investigational Site
Baxter Investigational Site
Baxter Investigational Site
Baxter Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artis Dialysis System

AK200 Ultra S

Arm Description

One midweek HDF session for a duration of 4 hours.

Outcomes

Primary Outcome Measures

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.

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.

Reduction ratio of β2-Microglobulin during and after Dialysis

Secondary Outcome Measures

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.

Urea Reduction Ratio (URR) during and after Dialysis

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."

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."

Full Information

NCT ID

NCT03859830

First Posted

February 28, 2019

Last Updated

December 5, 2019

Sponsor

Baxter Healthcare Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03859830

Brief 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)

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

January 22, 2019 (Actual)

Primary Completion Date

November 9, 2019 (Actual)

Study Completion Date

November 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End-Stage Renal Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

276 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Artis Dialysis System

Arm Type

Experimental

Arm Description

One midweek HDF session for a duration of 4 hours.

Arm Title

AK200 Ultra S

Arm Type

Active Comparator

Arm Description

One midweek HDF session for a duration of 4 hours.

Intervention Type

Device

Intervention Name(s)

Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

AK200 Ultra S, extracorporeal circulation conduct of blood purification

Intervention Description

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 Measure Information:

Title

Number of participants successfully completing HDF without interruption of therapy during Dialysis

Description

Time Frame