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

Fresenius Medical Care (FMC)

Status: Completed

Conditions: Renal Failure; End Stage Renal Disease

Treatments: Device: Dialyzer

Study type: Interventional

Funder types: Industry

Identifiers

NCT03315624

HD-FX-05-EU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

49 participants in 1 patient group

Hemodiafiltration HDF

Other group

Description:

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.

Treatment:

Device: Dialyzer