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

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ClinicalTrials.gov Identifier: NCT01578421
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : August 7, 2013
Sponsor:
Collaborator:
Fresenius Medical Care Deutschland GmbH
Information provided by (Responsible Party):
Andreas Bock, Kantonsspital Aarau

Tracking Information
First Submitted Date  ICMJE April 12, 2012
First Posted Date  ICMJE April 17, 2012
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE February 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
Clearance and removal rate of phosphate, beta2 microglobulin and leptin [ Time Frame: 4 hour ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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 Arms  ICMJE
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2013)
31
Original Estimated Enrollment  ICMJE
 (submitted: April 16, 2012)
30
Actual Study Completion Date  ICMJE December 2012
Actual 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01578421
Other Study ID Numbers  ICMJE HD-FX-01-CH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account Kantonsspital Aarau
Verification Date August 2013

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