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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) | Clinical Trials | Clareo Health

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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•Vantive Health LLC

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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
+3 more criteria

Locations (7)

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

Key Dates

Start Date

January 22, 2019

Primary Completion Date

November 9, 2019

Completion Date

November 9, 2019

Last Updated

March 13, 2025

Enrollment

276

ACTUAL participants

Conditions

End-Stage Renal Disease

Interventions

Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line

DEVICE

AK200 Ultra S, extracorporeal circulation conduct of blood purification

DEVICE

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

NCT04634916

Kidney Disease, End-StageEnd-stage Renal Disease+1 more

View study

RECRUITINGPHASE3

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

NCT06933472

HyperphosphatemiaChronic Kidney Disease, Receiving Dialysis+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

A Study of a Novel Iron-based Phosphate Binder AP301 in Patients With Hyperphosphatemia in the U.S. and China

Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD

Predictive Value of Carotid Ultrasonography for Intradialytic Hypotension

Comparative Study of Prognosis and QOL Between APD-RPM and CAPD

IVC and Lung Ultrasound B-lines Guided Decongestion in Critically Ill ESKD Patients With Heart Failure