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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)

NCT03859830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2025-03-13

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Vantive Health LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-22
Primary Completion
2019-11-09
Completion
2019-11-09

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03859830 on ClinicalTrials.gov