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

• 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

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

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

Arm && Interventions

Group	Intervention	Description
FX 100 dialyzer	4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)	-
Polyflux 210 H dialyzer	4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)	-
FXCorDiax 100 dialyzer	4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)	-

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

Trial Locations

Locations (1)

Nephrology Division, Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland