Molecule Removal and Ease of Use: A Comparison of Two Different Dialyzers

This study has been completed.
Sponsor:
Information provided by:
Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:
NCT00636389
First received: February 13, 2008
Last updated: July 18, 2011
Last verified: July 2011
  Purpose

The Polyflux HD-C4 (Gambro Renal Products) is a new dialyzer based on the existing Polyflux H membrane and dialyzer technology, but which achieves a performance comparable to Polyflux 210H in a significantly smaller device.

The objectives of this study are:

  1. To compare and contrast small and large molecule removal by the Polyflux HD-C4 and Polyflux 210H dialyzers under conditions of routine hemodialysis; and,
  2. To compare and contrast the ease of use of the Polyflux HD-C4 dialyzer with that of the Polyflux 210H under conditions of routine clinical use for hemodialysis.

Condition Intervention
Chronic Kidney Disease
Device: Polyflux 210H dialyzer
Device: Polyflux HD-C4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Urea, Phosphate and b2-Microglobulin Removal and Ease of Use: Comparing the Polyflux HD-C4 With the Polyflux 210H

Resource links provided by NLM:


Further study details as provided by Gambro Renal Products, Inc.:

Primary Outcome Measures:
  • Comparison of Urea Removal Under Conditions of Routine Hemodialysis. [ Time Frame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments ] [ Designated as safety issue: No ]
    Urea removal is correlated with successful clinical outcomes. Kt/V is a way of measuring the delivered dose of dialysis where K=clearance of urea, t=treatment time and V=volume of body water. Single-pool (sp) Kt/V assumes that urea is removed from a single compartment in the human body during dialysis. However, because there are multiple compartments in the human body, rebound occurs following hemodialysis which lowers the Kt/V. Equilibrated (e) Kt/V is an equation that has been devised to predict the amount of rebound based on the ratio of K/V. Outcomes are posted for both spKt/V and eKt/V.

  • A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis. [ Time Frame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments ] [ Designated as safety issue: No ]
    Overall removal of urea, phosphorus and β2-microglobulin was determined from the pre- to post-dialysis change in plasma concentration and from the amount of solute recovered in the dialysate. This outcome measure is reported as the percentage of pre- to post-dialysis reduction of urea, phosphorus and β2-microglobulin.


Secondary Outcome Measures:
  • Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H [ Time Frame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments ] [ Designated as safety issue: No ]
    Assessment of blood side priming: 1=Very Easy 2=Acceptable 3=Difficult 4=Very Difficult / Assessment of dialysate side priming: 1=Perfect 2=Acceptable 3= Not Acceptable / Appearance of dialyzer fibers: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of dialyzer arterial header: 1=Very Good 2=Good 3=Poor 4=Very Poor / Appearance of venous header: 1=Very Good 2=Good 3=Poor 4=Very Poor /


Enrollment: 12
Study Start Date: February 2008
Study Completion Date: March 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
HD-C4 First, then 210H
Subjects will be randomly assigned to begin the first week of three consecutive treatments with the Polyflux HD-C4 dialyzer. Following the third treatment, the subjects will be switched to the Polyflux 210H dialyzer for a second week of three consecutive treatments. Therefore each subject will have a total of six consecutive dialysis treatments.
Device: Polyflux 210H dialyzer
Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.
Other Name: Gambro Polyflux 210H dialyzer
Device: Polyflux HD-C4
Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.
Other Name: Gambro Revaclear
210H First, then HD-C4
Subjects will be randomly assigned to begin the first week of three consecutive treatments with the Polyflux 210H dialyzer. Following the third treatment, the subjects will be switched to the Polyflux HD-C4 dialyzer for a second week of three consecutive treatments. Therefore each subject will have a total of six consecutive dialysis treatments.
Device: Polyflux 210H dialyzer
Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.
Other Name: Gambro Polyflux 210H dialyzer
Device: Polyflux HD-C4
Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.
Other Name: Gambro Revaclear

  Eligibility

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

Inclusion Criteria:

  • Adults 18 years of age or older
  • Stable hemodialysis prescription using Polyflux 210H or Polyflux 21R for at least 2 months prior to study enrollment
  • Dialyzing through a native fistula or Gore-Tex graft.
  • Blood access must be able to provide a blood flow rate of 400 ml/min.

Exclusion Criteria:

  • Non-compliance with dialysis
  • Hematocrit less than 28%
  • Active Infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636389

Locations
United States, Minnesota
DaVita Clinical Research Facility
Minneapolis, Minnesota, United States, 55404
Sponsors and Collaborators
Gambro Renal Products, Inc.
Investigators
Principal Investigator: Harry Alcorn Jr., PharmD Davita Clinical Research Facility
  More Information

Publications:
Responsible Party: Harry Alcorn Jr., PharmD, DaVita Clinical Research
ClinicalTrials.gov Identifier: NCT00636389     History of Changes
Other Study ID Numbers: Gambro 1460
Study First Received: February 13, 2008
Results First Received: March 7, 2011
Last Updated: July 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Gambro Renal Products, Inc.:
Hemodialysis
Dialysis, Renal
Dialysis, Extracorporeal
Extracorporeal Dialysis

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

ClinicalTrials.gov processed this record on April 17, 2014