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)

Vantive Health LLC

Status

Completed

Conditions

End-Stage Renal Disease

Treatments

Device: AK200 Ultra S, extracorporeal circulation conduct of blood purification

Device: Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line

Study type

Interventional

Funder types

Industry

Identifiers

NCT03859830

BXU012184

Details and patient eligibility

About

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.

Enrollment

276 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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