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

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

Study Overview

• Status: Completed
• Conditions: Hemodialysis
• Intervention / Treatment: Other: dialyzer comparison; Device: Dialyzer

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dialyser; FX CorDiax 60 dialyzer	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
Active Comparator: FXDialyser; FX 60 dialyzer	Device: Dialyzer; Comparison Dialyzer FX60 versus Cordiax60

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Removal rate of myoglobin	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Removal rate of urea	2 weeks
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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Fresenius Medical Care Deutschland GmbH

Publications and helpful links

General Publications

• Maduell F, Arias-Guillen M, Fontsere N, Ojeda R, Rico N, Vera M, Elena M, Bedini JL, Wieneke P, Campistol JM. Elimination of large uremic toxins by a dialyzer specifically designed for high-volume convective therapies. Blood Purif. 2014;37(2):125-30. doi: 10.1159/000358214. Epub 2014 Mar 20.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: February 10, 2012
• First Submitted That Met QC Criteria: February 14, 2012
• First Posted (Estimate): February 17, 2012

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: HD-IIT-02-E