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

April 12, 2012
August 6, 2013
February 2012
September 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01578421 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser
Investigation on the Middle Size Molecule Elimination Characteristics of the FXCorDiax 100 in Relation to the FX 100 and the Polyflux 210 H Dialyser

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Renal Failure Chronic Requiring Hemodialysis
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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
December 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01578421
HD-FX-01-CH
No
Andreas Bock, Kantonsspital Aarau
Kantonsspital Aarau
Fresenius Medical Care Deutschland GmbH
Principal Investigator: Andreas Bock, MD Nephrology Division, Kantonsspital Aarau
Kantonsspital Aarau
August 2013

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