NCT03547323View on ClinicalTrials.gov

Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis to Determine Non-inferiority of the Theranova Dialyzer Compared to the FX80 Dialyzer

NACompletedINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

September 14, 2018

Primary Completion Date

June 14, 2019

Study Completion Date

June 14, 2019

Conditions
End Stage Renal Disease
Interventions
DEVICE

Theranova 400 Dialyzer

An existing functioning vascular access (AVF, graft) must be in place and will be used for dialysis. Treatments will be administered by trained clinical staff. The use of temporary or tunneled dialysis catheters will not be allowed.

DEVICE

FX80 Dialyzer

An existing functioning vascular access (AVF, graft) must be in place and will be used for dialysis. Treatments will be administered by trained clinical staff. The use of temporary or tunneled dialysis catheters will not be allowed.

Trial Locations (4)

100034

Investigational Site, Beijing

310014

Investigational Site, Hangzhou

510515

Investigational Site, Guangzhou

610041

Investigational Site, Chengdu

All Listed Sponsors
collaborator

Baxter Healthcare Corporation

INDUSTRY

lead

Vantive Health LLC

INDUSTRY

NCT03547323 - Study in End Stage Renal Disease (ESRD) Patients on Hemodialysis to Determine Non-inferiority of the Theranova Dialyzer Compared to the FX80 Dialyzer | Biotech Hunter | Biotech Hunter