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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 276 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-01-22
• Primary completion: 2019-11-09
• Completion: 2019-11-09
• First posted: 2019-03-01
• Last updated: 2025-03-13

Locations

7 sites across 1 country: China