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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014