Clinical trial NCT01534741: Comparison FX CorDiax 60 in Relation to the FX 60-Dialyzer
Official title: Investigation on the Middle Size Molecule Elimination Characteristics of the FX CorDiax 60 in Relation to the FX 60-Dialyzer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemodialysis
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care Deutschland GmbH
First posted: 2012-02-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Removal rate of myoglobin
timeFrame: 2 weeks
Secondary outcomes:
measure: Removal rate of urea
timeFrame: 2 weeks
measure: Removal rate of phosphate
timeFrame: 2 weeks
measure: Removal rate of ß2-microglobulin (ß2-m)
timeFrame: 2 weeks
measure: Removal rate of prolactin
timeFrame: 2 weeeks
measure: Removal rate of alpha1-microglobulin
timeFrame: 2 weeks
measure: Removal rate of alpha1-acid glycoprotein
timeFrame: 2 weeks
measure: Hematocrit pre and post-dialysis
timeFrame: 2 weeks
measure: Albumin loss during dialysis session
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic
Study officials:
References:
citation: 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.