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

Not Applicable

Completed

• Conditions: End Stage Renal Disease; Renal Failure
• Interventions: Device: Dialyzer

• Registration Number: NCT03611218
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

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 Timeline

• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Study Start: 2018-08-29
• Status Verified: 2018-12
• Primary Completion: 2018-12-08
• Study Completion: 2018-12-08
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Hemodiafiltration HDF	Dialyzer	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.

Primary Outcome Measures

Name	Time	Method
Removal rate of β2-microglobulin	t=240 minutes of HDF	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.

Secondary Outcome Measures

Name	Time	Method
Clearance of α1-microglobulin	t= 60 minutes of HDF
Clearance of β2-microglobulin	t=60 minutes of HDF
Removal rate of α1-microglobulin	t=240 minutes of HDF

Trial Locations

Locations (6)

Zentrum für Nieren-, Hochdruck- und Stoffwechselerkrankungen; 🇩🇪 Hannover, Niedersachsen, Germany

PHV Dialysezentrum Kiel; 🇩🇪 Kiel, Germany

PHV-Dialysezentrum Goslar; 🇩🇪 Goslar, Germany

Diakonissenkrankenhaus Flensburg; 🇩🇪 Flensburg, Germany

Georg-Haas-Dialysezentrum der PHV; 🇩🇪 Giessen, Germany

PHV-Dialysezentrum Lauterbach; 🇩🇪 Lauterbach, Germany