End Stage Renal Disease, Renal Failure
Conditions
Keywords
Hemodialysis, Hemodiafiltration, Renal replacement therapy
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.
Interventions
DEVICEDialyzer
Three hemodiafiltration sessions assigned to one type of dialyzer FX Coral 600, FX 600 and FX CorDiax 600
Sponsors
Fresenius Medical Care Deutschland GmbH
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Clearance of ß2-microglobulin | t=60 min. of HDF |
| Removal rates of myoglobin | t=240 min. of HDF |
| Clearances of myoglobin | t= 60 min. of HDF |
Countries
Germany
Outcome results
None listed