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

Hospital Clinic of Barcelona

Status and phase

Completed

Phase 4

Conditions

Hemodialysis

Treatments

Device: Dialyzer

Other: dialyzer comparison

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01534741

HD-IIT-02-E

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.