NCT04102280

Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration

Comparative Clinical Performance of Dialyzers Applied During High Volume Online Haemodiafiltration - comPERFORM Study (Comparative PERFORMance)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (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 generate clinical data on clearances and removal rates for ß2-microglobulin and other uremic toxins and on clinical adverse events of the modified polysulfone membrane to fulfil obligations to follow the FX P600 dialyzer in the market.

Detailed description

The primary objective of this study is to test whether the FX P600 is non-inferior to the Xevonta Hi 15 dialyzer and the Elisio 150H dialyzer in removing β2-microglobulin related to the albumin removal into the dialysate during high volume online hemodiafiltration. The secondary objective of this study is to compare the FX P600 dialyzer with the comparator dialyzers with regard to their efficacies in removing other performance variables (see below). Furthermore, the safety of the FX P600 will be investigated by collecting and analyzing clinical adverse events.

Conditions

• Renal Failure
• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Dialyser	Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro)

Timeline

• Start date: 2019-10-29
• Primary completion: 2020-11-06
• Completion: 2021-05-26
• First posted: 2019-09-25
• Last updated: 2021-12-02

Locations

4 sites across 1 country: Germany