Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane

Not Applicable

Completed

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

• Registration Number: NCT03315624
• Lead Sponsor: Fresenius Medical Care Deutschland GmbH

Brief Summary

The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone membrane to obtain CE-certification according to the European Medical Device Directive for the FX Coral 600 (TD 16-1) dialyzer.

Detailed Description

The FX Coral (TD 16-1) dialyzer is a new development with a modified polysulfone membrane and is not CE marked yet. The purpose of the clinical evaluation is to generate clinical data for the CE approval.

Study Timeline

• Study Start: 2017-10-06
• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-10-16
• Study First Posted: 2017-10-20
• Primary Completion: 2017-12-09
• Status Verified: 2018-03
• Study Completion: 2018-03-14
• Last Update Submitted: 2018-03-28
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Minimum age of 18 years
• Informed consent signed and dated by study patient and investigator / authorized physician
• Ability to understand the nature and requirements of the study

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 good 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 less or aged 55 years) or lactation period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Hemodiafiltration HDF	Dialyzer	Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration sessions with the dialyzer FX CORAL 600 (TD 16-1), the dialyzer FX CorDiax 600 or the dialyzer FX 600. In each week the patient is assigned to one type of dialyzer.

Primary Outcome Measures

Name	Time	Method
Removal rate of 2-microglobulin	t=240 min. of HDF	Removal rate of 2-microglobulin will be calculated as primary endpoint in blood samples to evaluate the clinical performance of the new FX Coral 600 (TD 16-1) dialyzer.

Secondary Outcome Measures

Name	Time	Method
Removal rates of myoglobin	t=240 min. of HDF
Clearances of myoglobin	t= 60 min. of HDF
Clearance of ß2-microglobulin	t=60 min. of HDF

Trial Locations

Locations (1)

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