Status:
COMPLETED
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)
Lead Sponsor:
Vantive Health LLC
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
End-Stage Renal Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
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 accessib...
Eligibility Criteria
Inclusion
- 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:
- Kt/Vurea ≥ 1.2 which is taken within 4 weeks before study enrollment
- 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
- 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
Key Trial Info
Start Date :
January 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2019
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT03859830
Start Date
January 22 2019
End Date
November 9 2019
Last Update
March 13 2025
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site
Beijing, Beijing Municipality, China, 100730
2
Investigational Site
Foshan, Guangdong, China, 528000
3
Investigational Site
Wuhan, Hubei, China, 430060
4
Investigational Site
Nanjing, Jiangsu, China, 210009