NCT03611218

Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration

Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration - eMPORA II Study (Modified POlysulfone membRAne)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The clinical Investigation will be performed to compare the safety and clinical performance profile of different hemodialyzers, all applied in on-line postdilution hemodiafiltration

Detailed description

The primary objective of this study is to test whether the new FX P600 (applied during post-dilution online HDF) is non-inferior to two comparator dialyzers (Sureflux-17UX (Nipro) and Polyflux 170 H (Baxter/Gambro) in removing β2-microglobulin. The secondary objective is to exploratively compare the efficacy in removing other uremic solutes between the new FX P600 and the Sureflux-17UX as well as the Polyflux 170 H membranes. Additionally, the safety of the FX P600 dialyzer with a modified polysulfone membrane will be investigated.

Conditions

• Renal Failure
• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Dialyzer	Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H

Timeline

• Start date: 2018-08-29
• Primary completion: 2018-12-08
• Completion: 2018-12-08
• First posted: 2018-08-02
• Last updated: 2018-12-19

Locations

6 sites across 1 country: Germany