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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01534741
• Other study ID #: HD-IIT-02-E
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2012
• Last updated: April 8, 2014
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hemodialysis

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínic	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Fresenius Medical Care Deutschland GmbH

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Maduell F, Arias-Guillen M, Fontseré 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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Removal rate of myoglobin		2 weeks	No
Secondary	Removal rate of urea		2 weeks	No
Secondary	Removal rate of phosphate		2 weeks	No
Secondary	Removal rate of ß2-microglobulin (ß2-m)		2 weeks	No
Secondary	Removal rate of prolactin		2 weeeks	No
Secondary	Removal rate of alpha1-microglobulin		2 weeks	No
Secondary	Removal rate of alpha1-acid glycoprotein		2 weeks	No
Secondary	Hematocrit pre and post-dialysis		2 weeks	Yes
Secondary	Albumin loss during dialysis session		2 weeks	Yes