Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane (eMPORA)

March 28, 2018 updated by: Fresenius Medical Care Deutschland GmbH

Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane - eMPORA Study (Modified POlysulfone membRAne)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Gießen, Germany, 35392
        • Georg-Haas-Dialysezentrum der PHV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Hemodiafiltration HDF
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.
Device: Dialyzer
Three hemodiafiltration sessions assigned to one type of dialyzer FX Coral 600, FX 600 and FX CorDiax 600

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Removal rate of 2-microglobulin
Time Frame: 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.
t=240 min. of HDF

Secondary Outcome Measures

Outcome Measure
Time Frame
Clearance of ß2-microglobulin
Time Frame: t=60 min. of HDF
t=60 min. of HDF
Removal rates of myoglobin
Time Frame: t=240 min. of HDF
t=240 min. of HDF
Clearances of myoglobin
Time Frame: t= 60 min. of HDF
t= 60 min. of HDF

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Medical Care Deutschland GmbH

Investigators

  • Principal Investigator: Stephan Wagner, Dr, Georg-Haas-Dialysezentrum der PHV, Giessen, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2017

Primary Completion (Actual)

December 9, 2017

Study Completion (Actual)

March 14, 2018

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (Actual)

October 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-FX-05-EU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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