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

August 6, 2013 updated by: Andreas Bock, Kantonsspital Aarau
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Aarau, Switzerland, CH-5001
        • Nephrology Division, Kantonsspital Aarau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: FX 100 dialyzer
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
Other: Polyflux 210 H dialyzer
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
Other: FXCorDiax 100 dialyzer
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clearance and removal rate of phosphate, beta2 microglobulin and leptin
Time Frame: 4 hour
during a 4 hour online hemodiafiltration session
4 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kantonsspital Aarau

Collaborators

Fresenius Medical Care Deutschland GmbH

Investigators

  • Principal Investigator: Andreas Bock, MD, Nephrology Division, Kantonsspital Aarau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 17, 2012

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HD-FX-01-CH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Failure Chronic Requiring Hemodialysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe