Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser

Kantonsspital Aarau

Status

Completed

Conditions

Renal Failure Chronic Requiring Hemodialysis

Treatments

Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01578421

HD-FX-01-CH

Details and patient eligibility

About

The purpose of the study is to compare clearance and removal rates of phosphate, ß2-microglobulin (ß2-m) and leptin and albumin loss with different dialyser membranes during post-dilution online hemodiafiltration.

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

hemodialysis patients 18 years and older
treated by post dilution on-line Hemodiafiltration (HDF) for at least one month
who reached a dialysis dose (Kt/V) of at least 1.2 at each of the last two monthly checks
who are on a stable anticoagulation and anemia management
whose hemoglobin is between 10.5 and 13.0 g/dl
who are clinically stable based on judgment of nephrologist
who are on a regular thrice weekly HDF schedule, e.g. Monday-Wednesday-Friday or Tuesday-Thursday-Saturday,
who have a good vascular access (fistula or graft) which enables easy insertion of the needles and suitable effective blood flow (> 300 ml/min)
who are able to understand the nature and requirements of the clinical investigation and who have given written informed consent

Exclusion Criteria: Patients

with active Hepatitis B, Hepatitis C or HIV infection
who are severely malnourished as judged by the principal investigator
who are known or suspected to have allergy to the trial products or related products
with a central venous catheter based vascular access
who are abusing non-legal drugs or alcohol
who have currently active malignant disease
who are female of child-bearing age without effective measures of contraception, pregnant or breastfeeding
who participate simultaneously in another clinical investigation
who have participated in othe clinical investigations during the last month
who are uncooperative