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

Phase 4

Completed

• Conditions: Hemodialysis
• Interventions: Other: dialyzer comparison; Device: Dialyzer

• Registration Number: NCT01534741
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-14
• Study First Posted: 2012-02-17
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Patients who are treated by post dilution on-line HDF for at least three months.
• Patients who reached a dialysis dose (Kt/V) of at least 1.2 at the last two monthly checks,
• Patients who are on a stable anticoagulation and anemia management,
• Patients who are clinically stable outlined by the medical history of the patient, based on judgment of principal investigator,
• Patients who are on a regular thrice weekly HDF schedule,
• Patients who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (> 300 ml/min),
• Patients who are able to understand the nature and requirements of the clinical investigation and have given written informed consent,
• Patients who are aged 18 years or older.

Exclusion Criteria

• Patients who do not meet the inclusion criteria,
• Patients with active HBV, HCV, HIV infection,
• Patients who are severely malnourished patients as judged by the principal investigator,
• Patients who are known or suspected to have allergy to the trial products or related products,
• Patients who are abusing non-legal drugs or alcohol (defined as an average daily intake of more than one liter of beer per day or an equivalent amount of alcohol in other beverages),
• Patients who have been diagnosed a current active malignant disease,
• Patients who participate simultaneously in another clinical investigation or in other clinical investigations during the last month,
• Patients who are uncooperative.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dialyser	dialyzer comparison	FX CorDiax 60 dialyzer
Dialyser	Dialyzer	FX CorDiax 60 dialyzer
FXDialyser	Dialyzer	FX 60 dialyzer

Primary Outcome Measures

Name	Time	Method
Removal rate of myoglobin	2 weeks

Secondary Outcome Measures

Name	Time	Method
Removal rate of phosphate	2 weeks
Removal rate of ß2-microglobulin (ß2-m)	2 weeks
Removal rate of prolactin	2 weeeks
Removal rate of alpha1-microglobulin	2 weeks
Removal rate of alpha1-acid glycoprotein	2 weeks
Hematocrit pre and post-dialysis	2 weeks
Albumin loss during dialysis session	2 weeks
Removal rate of urea	2 weeks

Trial Locations

Locations (1)

Hospital Clínic; 🇪🇸 Barcelona, Spain