Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser
NCT ID: NCT01578421
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
31 participants
INTERVENTIONAL
2012-02-29
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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FX 100 dialyzer
4 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
Polyflux 210 H dialyzer
4 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
FXCorDiax 100 dialyzer
4 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
Interventions
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4 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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Fresenius Medical Care Deutschland GmbH
INDUSTRY
Kantonsspital Aarau
OTHER
Responsible Party
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Andreas Bock
Prof. Andreas Bock, Chefarzt Nephrologie
Principal Investigators
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Andreas Bock, MD
Role: PRINCIPAL_INVESTIGATOR
Nephrology Division, Kantonsspital Aarau
Locations
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Nephrology Division, Kantonsspital Aarau
Aarau, , Switzerland
Countries
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Other Identifiers
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HD-FX-01-CH
Identifier Type: -
Identifier Source: org_study_id