Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration

NACompletedINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

April 11, 2018

Primary Completion Date

October 4, 2018

Study Completion Date

October 4, 2018

Conditions
End Stage Renal Disease
Interventions
DEVICE

Theranova 500 medium cut-off dialyzer

The patients randomized in this group using the Theranova 500 medium cut-off dialyzer, and blood flow rate and treatment duration will be maintained stable during the observation period. However, other prescriptions will vary based on the Principal Investigator's (PI's) judgment. If other dialyzers need to be temporarily used during the study period it shall be recorded which alternative dialyzers are used and for how long the study patient is on a different dialyzer. However, prior to Week 12 laboratory assessment it is recommended that the patient undergoes three dialysis sessions on the designated treatment mode.

DEVICE

Hemodiafiltration

The patients randomized in this group using the on-line high-flux HDF dialyzer, in post dilution mode, will continue to receive treatments according to their current treatment prescriptions for the duration of the study.

Trial Locations (1)

Unknown

RTS Murcia VII, RTS Servicios de Diálisis S.L.U., Murcia

All Listed Sponsors
collaborator

Baxter Healthcare Corporation

INDUSTRY

lead

Vantive Health LLC

INDUSTRY

NCT03499691 - Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration | Biotech Hunter | Biotech Hunter