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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polyflux 210H dialyzer
Polyflux HD-C4
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Hemodialysis, Dialysis, Renal, Dialysis, Extracorporeal, Extracorporeal Dialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DaVita Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

HD-C4 First, then 210H

210H First, then HD-C4

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Comparison of Urea Removal Under Conditions of Routine Hemodialysis.
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.
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
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 /

Full Information

First Posted
February 13, 2008
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Renal Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00636389
Brief Title
Molecule Removal and Ease of Use: A Comparison of Two Different Dialyzers
Official Title
Urea, Phosphate and b2-Microglobulin Removal and Ease of Use: Comparing the Polyflux HD-C4 With the Polyflux 210H
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
Gambro Renal Products, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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: To compare and contrast small and large molecule removal by the Polyflux HD-C4 and Polyflux 210H dialyzers under conditions of routine hemodialysis; and, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Hemodialysis, Dialysis, Renal, Dialysis, Extracorporeal, Extracorporeal Dialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HD-C4 First, then 210H
Arm Type
Other
Arm Description
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.
Arm Title
210H First, then HD-C4
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Polyflux 210H dialyzer
Other Intervention Name(s)
Gambro Polyflux 210H dialyzer
Intervention Description
Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.
Intervention Type
Device
Intervention Name(s)
Polyflux HD-C4
Other Intervention Name(s)
Gambro Revaclear
Intervention Description
Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.
Primary Outcome Measure Information:
Title
Comparison of Urea Removal Under Conditions of Routine Hemodialysis.
Description
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.
Time Frame
2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments
Title
A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis.
Description
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.
Time Frame
2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments
Secondary Outcome Measure Information:
Title
Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H
Description
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 /
Time Frame
2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Alcorn Jr., PharmD
Organizational Affiliation
Davita Clinical Research Facility
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaVita Clinical Research Facility
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8305648
Citation
Daugirdas JT. Second generation logarithmic estimates of single-pool variable volume Kt/V: an analysis of error. J Am Soc Nephrol. 1993 Nov;4(5):1205-13. doi: 10.1681/ASN.V451205.
Results Reference
background
PubMed Identifier
8573901
Citation
Daugirdas JT, Schneditz D. Overestimation of hemodialysis dose depends on dialysis efficiency by regional blood flow but not by conventional two pool urea kinetic analysis. ASAIO J. 1995 Jul-Sep;41(3):M719-24. doi: 10.1097/00002480-199507000-00107.
Results Reference
background

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

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