Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser
Not Applicable
Completed
- Conditions
- Renal Failure Chronic Requiring Hemodialysis
- Registration Number
- NCT01578421
- Lead Sponsor
- Kantonsspital Aarau
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method Clearance and removal rate of phosphate, beta2 microglobulin and leptin 4 hour during a 4 hour online hemodiafiltration session
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of phosphate and beta-2-microglobulin clearance in online hemodiafiltration using FXCorDiax 100 vs FX 100 and Polyflux 210 H dialyzers?
How does FXCorDiax 100 membrane performance compare to FX 100 and Polyflux 210 H in removing middle molecules like leptin during hemodiafiltration?
What biomarkers predict differential albumin loss with FXCorDiax 100 versus conventional dialyzers in chronic hemodialysis patients?
Are there specific adverse events associated with FXCorDiax 100 membrane in online hemodiafiltration compared to standard dialysis membranes?
What are the comparative advantages of FXCorDiax 100 over FX 100 and Polyflux 210 H in managing middle molecule retention in end-stage renal disease?
Trial Locations
- Locations (1)
Nephrology Division, Kantonsspital Aarau
🇨🇭Aarau, Switzerland
Nephrology Division, Kantonsspital Aarau🇨🇭Aarau, Switzerland