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

Chronic Kidney Disease Clinical Trial

Official title:

Urea, Phosphate and b2-Microglobulin Removal and Ease of Use: Comparing the Polyflux HD-C4 With the Polyflux 210H

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636389
• Other study ID #: Gambro 1460
• Status: Completed
• Phase: N/A
• First received: February 13, 2008
• Last updated: July 18, 2011
• Start date: February 2008
• Est. completion date: March 2009

Study information

• Verified date: July 2011
• Source: Gambro Renal Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Device:
• Polyflux 210H dialyzer
Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.
• Polyflux HD-C4
Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.

Locations

Country	Name	City	State
United States	DaVita Clinical Research Facility	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Gambro Renal Products, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments	No
Primary	A Comparison of Pre- to Post-dialysis Reduction of Small and Large Molecules Under Conditions of Routine Hemodialysis.	Overall removal of urea, phosphorus and ß2-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 ß2-microglobulin.	2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments	No
Secondary	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 /	2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments	No