N18.5
Conditions
Interventions
Group 1: Dialysis with hemodialyser FX CorDiax 100 - treatment modality hemodialysis (HD), 3 treatments per week for one week
Group 2: Dialysis with hemodialyser FX CorDiax 100 - treatment modality he
Sponsors
Fresenius Medical Care Deutschland GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: General: •Minimum age of 18 years •Informed consent signed and dated by study patient and investigator/authorised physician •Ability to understand the nature and requirements of the study Study-specific: •On maintenance high-flux hemodialysis or on-line hemodiafiltration (three times/week) for = 3 months, at least 4 h treatment time •Vascular access (fistula or graft) which enables suitable effective blood flow rate (= 300 ml/min)
Exclusion criteria
Exclusion criteria: General: •Any condition which could interfere with the patient’s ability to comply with the study •Ongoing participation in an interventional clinical study or during the preceding 30 days •Previous participation in this study •(in case of female patients:) Pregnancy or lactation period Study-specific: •Recurrent episodes of vascular access failure •Single needle treatments •Catheter as vascular access •Instable patients (due to e.g. acute intercurrent disease like cardiovascular infarction, active malignant disease) •Patients with NYHA =3, COPD, frequent intradialytic hypotension •Patients with known or suspected allergy to trial product, related products or with other allergies, or on antiallergic medication •Planned absence from dialysis unit within the next 3 weeks e.g. due to scheduled hospitalisation/holidays •Active HBV, HCV, HIV infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Due to the explorative nature of this study no explicit primary variable has been defined. Instead, the analysis of a set of laboratory parameters shall provide a typical profile indicative of biocompatibility of the hemodialyser, and possible impact by treatment modality, respectively. These factors are: Factors of complement activation, Markers of cell activation, Inflammatory and other markers. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety variables: Electrolytes, Blood gas analysis, Adverse events | — |
Countries
Germany
Contacts
Public ContactStephan Wagner
Georg-Haas-Dialysezentrum der PHV
Outcome results
None listed