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)

NCT ID: NCT03859830

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-22
• Study Completion Date: 2019-11-09

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.

Conditions

End-Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artis Dialysis System

One midweek HDF session for a duration of 4 hours.

Group Type: EXPERIMENTAL

Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line

Intervention Type: DEVICE

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

One midweek HDF session for a duration of 4 hours.

Group Type: ACTIVE_COMPARATOR

AK200 Ultra S, extracorporeal circulation conduct of blood purification

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Vantive Health LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Investigational Site

Beijing, Beijing Municipality, China

Investigational Site

Foshan, Guangdong, China

Investigational Site

Wuhan, Hubei, China

Investigational Site

Nanjing, Jiangsu, China

Investigational Site

Shenyang, Liaoning, China

Investigational Site

Hangzhou, Zhejiang, China

Investigational Site

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

BXU012184

Identifier Type: -

Identifier Source: org_study_id