The study investigates the performance of a new dialyzer (Theranova 400) containing a membrane with increased pore sizes. The performance will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Two different Theranova 400 prototypes (AA and BB) operated in hemodialysis mode will be compared with a Cordiax Fx-80 dialyzer, operated in hemodialysis mode, and with a Cordiax Fx-800, operated in high volume hemodiafiltration mode. Safety events and albumin loss into the dialysate will be monitored
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Dialysexentrum Elsenfeld
Elsenfeld, Germany
Overall clearance of lambda FLC clearance
Blood and dialysate
Time frame: Five (5) hours ( for each mid-week dialysis session)
Overall albumin loss
Dialysate
Time frame: Five (5) hours (for each mid-week dialysis session)
Types and frequency of adverse events and device deficiencies as a measure of safety and dialyzer tolerability
All adverse events and device deficiencies will be recorded
Time frame: Average 60 days (continuously, from signature of informed consent form until 1 week after last hemodialysis session with an experimental or active comparator product)
Clearance of other middle sized molecules
Blood and dialysate
Time frame: Five (5) hours (for each mid-week dialysis session)
Hematology ( blood cell counts; hematocrit and hemoglobin)
Blood
Time frame: Five (5) hours ( for each mid-week dialysis session)
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