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 has been completed.
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: August 6, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Renal Failure Chronic Requiring Hemodialysis
Device: 4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser

Further study details as provided by Kantonsspital Aarau:

Primary Outcome Measures:
  • 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


Enrollment: 31
Study Start Date: February 2012
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578421

Locations
Switzerland
Nephrology Division, Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Sponsors and Collaborators
Kantonsspital Aarau
Fresenius Medical Care Deutschland GmbH
Investigators
Principal Investigator: Andreas Bock, MD Nephrology Division, Kantonsspital Aarau
  More Information

Additional Information:
No publications provided

Responsible Party: Andreas Bock, Prof. Andreas Bock, Chefarzt Nephrologie, Kantonsspital Aarau
ClinicalTrials.gov Identifier: NCT01578421     History of Changes
Other Study ID Numbers: HD-FX-01-CH
Study First Received: April 12, 2012
Last Updated: August 6, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 20, 2014