Clinical trial NCT03859830: 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
Overall status: COMPLETED
Phase: NA
Conditions: End-Stage Renal Disease
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2019-03-01
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of participants successfully completing HDF without interruption of therapy during Dialysis
timeFrame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
measure: Number of Participants by Level of Effectiveness of Disposable Tubing during and after Dialysis
timeFrame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
measure: Reduction ratio of β2-Microglobulin during and after Dialysis
timeFrame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Secondary outcomes:
measure: Single-pool Kt/V urea during and after Dialysis
timeFrame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
measure: Urea Reduction Ratio (URR) during and after Dialysis
timeFrame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
measure: Number of Participants by Level of Appearance of Disposable Tubing during and after Dialysis
timeFrame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
measure: Number of Participants by Level of Elasticity of Pump Lines during and after Dialysis
timeFrame: Day 1 (One Midweek HDF Treament Session, 4 hour duration)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational Site
state: Beijing
city: Foshan
country: China
facility: Investigational Site
state: Guangdong
city: Wuhan
country: China
facility: Investigational Site
state: Hubei
city: Nanjing
country: China
facility: Investigational Site
state: Jiangsu
city: Shenyang
country: China
facility: Investigational Site
state: Liaoning
city: Hangzhou
country: China
facility: Investigational Site
state: Zhejiang
city: Wenzhou
country: China
facility: Investigational Site
state: Zhejiang
Study officials:
References: