NCT01534741

Comparison FX CorDiax 60 in Relation to the FX 60-Dialyzer

Investigation on the Middle Size Molecule Elimination Characteristics of the FX CorDiax 60 in Relation to the FX 60-Dialyzer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hemodialysis

Interventions

Type	Name	Description
OTHER	dialyzer comparison	Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type (FX CorDiax 60or FX 60 ) The order of dialyzers used will be randomly assigned to the patient at the time of randomisation by lot. Every subject will be treated one time with each dialyzer. In order to achieve controlled conditions, the mid- or end-week session data will be used, only.
DEVICE	Dialyzer	Comparison Dialyzer FX60 versus Cordiax60

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-02-17
• Last updated: 2014-04-09

Locations

1 site across 1 country: Spain