Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2026-03-09 @ 4:46 AM
Study NCT ID:
NCT03611218
Status:
COMPLETED
Last Update Posted:
2018-12-19
First Post:
2018-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration
Sponsor:
Fresenius Medical Care Deutschland GmbH
Organization:
Study Overview
Official Title:
Comparative Safety and Clinical Performance of Dialyzers Applied During Post-dilution Online Hemodiafiltration - eMPORA II Study (Modified POlysulfone membRAne)
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eMPORA II
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: