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Completed

NCT Number: NCT03315624

Safety and Clinical Performance of a Dialyzer With a 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.

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Key information

Conditions

Renal Failure Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georg-Haas-Dialysezentrum der PHV

Giessen, 35392, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dialyzer

Device

Three hemodiafiltration sessions assigned to one type of dialyzer FX Coral 600, FX 600 and FX CorDiax 600

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clearance of ß2-microglobulin

    Time frame: t=60 min. of HDF

  2. Removal rates of myoglobin

    Time frame: t=240 min. of HDF

  3. Clearances of myoglobin

    Time frame: t= 60 min. of HDF

Sponsors and collaborators

Lead sponsor

Fresenius Medical Care Deutschland GmbH

Industry

Registry information

Official study title

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

Acronym: eMPORA

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Oct 20, 2017
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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