Renal Failure Chronic Requiring Hemodialysis
Conditions
Brief summary
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.
Interventions
DEVICE4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)
4 h online hemodiafiltration with measurement of clearance and removal rate by split dialysate collection and bloodside measurements
Sponsors
Fresenius Medical Care Deutschland GmbH
Kantonsspital Aarau
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clearance and removal rate of phosphate, beta2 microglobulin and leptin | 4 hour | during a 4 hour online hemodiafiltration session |
Countries
Switzerland
Outcome results
None listed