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

NCT00636389 | Completed Results

• 1 other identifier: Gambro 1460
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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:

1. 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. 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.

Conditions

Chronic Kidney Disease

Keywords

Hemodialysis; Dialysis, Renal; Dialysis, Extracorporeal; Extracorporeal Dialysis

Outcome Measures

Primary Outcomes (2)

• 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

• 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.

  2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments

Secondary Outcomes (1)

• Comparison of Dialyzer Ease of Use Between the Polyflux HD-C4 Dialyzer and the Polyflux 210H

  2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments

Study Arms (2)

HD-C4 First, then 210H

OTHER

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; Device: Polyflux HD-C4

210H First, then HD-C4

OTHER

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; Device: Polyflux HD-C4

Interventions

Polyflux 210H dialyzer DEVICE

Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.

Also known as: Gambro Polyflux 210H dialyzer

210H First, then HD-C4; HD-C4 First, then 210H

Polyflux HD-C4 DEVICE

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

Also known as: Gambro Revaclear

210H First, then HD-C4; HD-C4 First, then 210H

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Non-compliance with dialysis
• Hematocrit less than 28%
• Active Infection

Sponsors & Collaborators

• Vantive Health LLC: lead
• Gambro Renal Products, Inc.: collaborator
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

DaVita Clinical Research Facility

Minneapolis, Minnesota, 55404, United States

Location

Related Publications (2)

• 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.

  PMID: 8305648 BACKGROUND

• 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.

  PMID: 8573901 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global CORP Clinical Trials Disclosure
• Organization: Vantive

Global.CORP.ClinicalTrialsDisclosure@vantive.com

+1 2249484283

Study Officials

• Harry Alcorn Jr., PharmD

  Davita Clinical Research Facility

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2008
• First Posted: March 14, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: July 14, 2025
• Results First Posted: August 11, 2011

Record last verified: 2025-07

Locations

US (1)