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)

End-Stage Renal Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03859830
• Other study ID #: BXU012184
• Status: Completed
• Phase: N/A
• Start date: January 22, 2019
• Est. completion date: November 9, 2019

Study information

• Verified date: December 2019
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: November 9, 2019
• Est. primary completion date: November 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Baxter Investigational Site	Beijing	Beijing
China	Baxter Investigational Site	Foshan	Guangdong
China	Baxter Investigational Site	Hangzhou	Zhejiang
China	Baxter Investigational Site	Nanjing	Jiangsu
China	Baxter Investigational Site	Shenyang	Liaoning
China	Baxter Investigational Site	Wenzhou	Zhejiang
China	Baxter Investigational Site	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	Reduction ratio of ß2-Microglobulin during and after Dialysis		Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Secondary	Single-pool Kt/V urea during and after Dialysis	Computing formula: spKt/V = -ln (R - 0.008t) + (4 - 3.5R) x (?BW/BW). Where R is the blood urea after hemodialysis/ blood urea before hemodialysis; t is time in hours; ?BW 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)
Secondary	Urea Reduction Ratio (URR) during and after Dialysis		Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Secondary	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)
Secondary	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)