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

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

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

Study Overview

• Status: Completed
• Conditions: Renal Failure; End Stage Renal Disease
• Intervention / Treatment: Device: Dialyzer

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Flensburg, Germany, 24939
    • Diakonissenkrankenhaus Flensburg
  • Giessen, Germany, 35392
    • Georg-Haas-Dialysezentrum der PHV
  • Goslar, Germany, 38642
    • PHV-Dialysezentrum Goslar
  • Kiel, Germany, 24106
    • PHV Dialysezentrum Kiel
  • Lauterbach, Germany, 36341
    • PHV-Dialysezentrum Lauterbach
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30453
      • Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hemodiafiltration HDF; Three consecutive treatment weeks and on follow-up week per patient. Each treatment week includes three hemodiafiltration HDFsessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Nipro: Sureflux-17UX and comparator Baxter/Gambro: Polyflux 170 H.	Device: Dialyzer; Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Removal rate of β2-microglobulin	Removal rate of β2-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 Outcome Measures

Outcome Measure	Time Frame
Clearance of β2-microglobulin	t=60 minutes of HDF
Removal rate of α1-microglobulin	t=240 minutes of HDF
Clearance of α1-microglobulin	t= 60 minutes of HDF

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Deutschland GmbH

Publications and helpful links

General Publications

• Ehlerding G, Erlenkotter A, Gauly A, Griesshaber B, Kennedy J, Rauber L, Ries W, Schmidt-Gurtler H, Stauss-Grabo M, Wagner S, Zawada AM, Zschatzsch S, Kempkes-Koch M. Performance and Hemocompatibility of a Novel Polysulfone Dialyzer: A Randomized Controlled Trial. Kidney360. 2021 Apr 7;2(6):937-947. doi: 10.34067/KID.0000302021. eCollection 2021 Jun 24.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2018
• Primary Completion (Actual): December 8, 2018
• Study Completion (Actual): December 8, 2018

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Renal replacement therapy; Hemodialysis; Hemodiafiltration
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: HD-FX-06-D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No