NCT04714281

Comparison of Clinical Performance and Hemocompatibility of Dialyzers Applied During Post-dilution Online Hemodiafiltration

Comparison of Clinical Performance and Hemocompatibility of Dialyzers Applied During Post-dilution Online Hemodiafiltration - eMPORA III Study (Modified POlysulfone membRAne)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 82 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Comparison of the clinical performance and the hemocompatibility profile of different high-flux dialyzers, all applied during post-dilution online hemodiafiltration

Detailed description

The primary objective of this study is to test whether the hemodialyzer FX CorAL 600 (applied during post-dilution online hemodiafiltration) is non-inferior or superior to the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 in removing ß2-microglobulin. The secondary objectives of this study are: * To compare the FX CorAL 600 dialyzer with the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 regarding their efficacies in removing other uremic toxins. * To compare the FX CorAL 600 dialyzer with the comparator hemodialyzers FX CorDiax 600 and xevonta Hi 15 regarding their hemocompatibility profiles.

Conditions

• Renal Failure
• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Dialyser	Three consecutive treatment periods of four weeks, one last study week where the patient is re-assigned to the same type of dialyzer used before beginning the study and one follow-up week per patient. Each treatment period includes 12 hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX CorAL 600 Fresenius Medical Care, comparator FX CorDiax 600 Fresenius Medical Care and comparator xevonta Hi 15 (B. Braun).

Timeline

• Start date: 2021-02-03
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2021-01-19
• Last updated: 2024-09-27

Locations

8 sites across 3 countries: Czechia, Germany, Hungary