Hemodialysis Clinical Trial
Official title:
Investigation on the Middle Size Molecule Elimination Characteristics of the FX CorDiax 60 in Relation to the FX 60-Dialyzer
Study design: Open, randomized, cross-over, monocentric, controlled, prospective Applied
Medical Devices: FX CorDiax 60 (high-flux), FX 60 (high-flux) Patients: 30 adult chronic
hemodialysis patients Treatment: Each patient will be treated by post-dilution online
hemodiafiltration once with each dialyzer type.
Study objectives: Intraindividual comparison of removal rate of urea, phosphate,
ß2-microglobulin (ß2-m), myoglobin, prolactin, alpha1-microglobulin and
alpha1-acidglycoprotein and of the albumin loss with different dialyzer membranes during
post-dilution online hemodiafiltration.
Primary variable: Removal rate of myoglobin Secondary variable: Removal rate of urea,
phosphate, ß2-microglobulin (ß2-m), prolactin, alpha1-microglobulin and
alpha1-acidglycoprotein Safety variable: Hematocrit, albumin loss Sample Size: 30 subjects
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label
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