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

This study is currently recruiting participants.

Verified April 2012 by Kantonsspital Aarau

Sponsor:

Collaborator:

Fresenius Medical Care Deutschland GmbH

Information provided by (Responsible Party):

Andreas Bock, Kantonsspital Aarau

ClinicalTrials.gov Identifier:

NCT01578421

First received: April 12, 2012

Last updated: April 16, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

April 12, 2012

Last Updated Date

April 16, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clearance and removal rate of phosphate, beta2 microglobulin and leptin [ Time Frame: 4 hour ] [ Designated as safety issue: No ]

during a 4 hour online hemodiafiltration session

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01578421 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Renal Failure Chronic Requiring Hemodialysis

Intervention ^ICMJE

Device: 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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2012

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

hemodialysis patients 18 years and older
treated by post dilution on-line 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 HBV, HCV, 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Andreas Bock, MD	+41-62-838 4305	andreas.bock@ksa.ch
Contact: Beatrice Paul, MD	+41-62-838 5683	beatrice.paul@ksa.ch

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01578421

Other Study ID Numbers ^ICMJE

HD-FX-01-CH

Has Data Monitoring Committee

Responsible Party

Andreas Bock, Kantonsspital Aarau

Study Sponsor ^ICMJE

Kantonsspital Aarau

Collaborators ^ICMJE

Fresenius Medical Care Deutschland GmbH

Investigators ^ICMJE

Principal Investigator:

Andreas Bock, MD

Nephrology Division, Kantonsspital Aarau

Information Provided By

Kantonsspital Aarau

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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