NCT02377570

Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode

Comparison of the Clinical Performance of 3 THERANOVA 400 Dialyzer Prototypes With a High-Flux Dialyzer in Hemodialysis Mode - A Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study investigates the performance of a new dialyzer (Theranova 400) containing a membrane with increased pore sizes. The performance will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Three different Theranova 400 prototypes (AA, BB and CC) operated in hemodialysis mode will be compared with a Cordiax FX-80 dialyzer, operated in hemodialysis mode. Safety events and albumin loss into the dialysate will be monitored

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	THERANOVA 400 dialyzer prototype AA	Hemodialysis
DEVICE	THERANOVA 400 dialyzer prototype BB	Hemodialysis
DEVICE	THERNOVA 400 dialyzer prototype CC	Hemodialysis
DEVICE	FX CorDiax 80 dialyzer	Hemodialysis

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-03-03
• Last updated: 2025-03-13

Locations

1 site across 1 country: Austria