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

End Stage Renal Disease Clinical Trial

— eMPORA II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611218
• Other study ID #: HD-FX-06-D
• Status: Completed
• Phase: N/A
• Start date: August 29, 2018
• Est. completion date: December 8, 2018

Study information

• Verified date: December 2018
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 8, 2018
• Est. primary completion date: December 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Minimum age of 18 years

• Existing informed consent form signed and dated by study patient as well as investigator/authorized physician

• The patient is legally competent and able to understand the nature, risks, meaning, and consequences of the clinical trial and can subsequently declare his consent for participation in the clinical trial

• Patients with a chronic kidney disease stage 5D (end stage renal disease with a glomerular filtration rate of 15 ml/min or less) on hemodiafiltration as extracorporeal renal replacement therapy

Exclusion Criteria:

• Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general stable condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.).

• Ongoing participation in an interventional clinical study during the preceding 30 days

• Previous participation in this study

• Pregnancy (pregnancy test will be conducted with female patients aged = 55 years) or lactation period

• Patient is not able to give informed consent

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic
• Renal Failure
• Renal Insufficiency

Intervention

Device:
• Dialyzer
Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H

Locations

Country	Name	City	State
Germany	Diakonissenkrankenhaus Flensburg	Flensburg
Germany	Georg-Haas-Dialysezentrum der PHV	Giessen
Germany	PHV-Dialysezentrum Goslar	Goslar
Germany	Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen	Hannover	Niedersachsen
Germany	PHV Dialysezentrum Kiel	Kiel
Germany	PHV-Dialysezentrum Lauterbach	Lauterbach

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal rate of ß2-microglobulin	Removal rate of ß2-microglobulin will be calculated as primary endpoint in blood samples to evaluate the clinical performance of the new FX P600 dialyzer.	t=240 minutes of HDF
Secondary	Clearance of ß2-microglobulin		t=60 minutes of HDF
Secondary	Removal rate of a1-microglobulin		t=240 minutes of HDF
Secondary	Clearance of a1-microglobulin		t= 60 minutes of HDF