NCT02377622

Clinical Performance Comparison of 2 THERANOVA 400 Dialyzer Prototypes in HD With High-Flux Dialyzers in HD and hv HDF Mode

Comparison of the Clinical Performance of 2 THERANOVA 400 Dialyzer Prototypes in HD With a High-Flux Dialyzer in HD and a High-Flux Dialyzer in hvHDF - 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. Two different Theranova 400 prototypes (AA and BB) operated in hemodialysis mode will be compared with a Cordiax Fx-80 dialyzer, operated in hemodialysis mode, and with a Cordiax Fx-800, operated in high volume hemodiafiltration 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
DEVICE	THERANOVA 400 dialyzer prototype BB
DEVICE	FX CorDiax 80 Dialyzer
DEVICE	FX CorDiax 800 Dialyzer

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2015-03-03
• Last updated: 2025-03-13

Locations

1 site across 1 country: Germany