Chronic Kidney DiseaseNCT00636389

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

A study testing Polyflux 210H dialyzer and Polyflux HD-C4 in people with Chronic Kidney Disease, run by Vantive Health LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease
What is being tested?: Polyflux 210H dialyzer and Polyflux HD-C4
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Feb 2008to Mar 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

DaVita Clinical Research Facility
Minneapolis, Minnesota, 55404

Other trials in United States

About this study

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

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.

Conditions: Chronic Kidney Disease
Being tested: Polyflux 210H dialyzer, Polyflux HD-C4
Keywords: Hemodialysis, Dialysis, Renal, Dialysis, Extracorporeal, Extracorporeal Dialysis
Medical subject headings: Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Polyflux 210H dialyzerDevice
Also called Gambro Polyflux 210H dialyzer
Three consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.
Polyflux HD-C4Device
Also called Gambro Revaclear
Three consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.

Study groups in NCT00636389
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Polyflux 210H dialyzer; Device: Polyflux HD-C4

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
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 /
Measured: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Mar 2009

First posted14 Mar 2008 (estimated)
Study startFeb 2008
Primary completionDec 2008
Study completionMar 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00636389
Sponsor's protocol ID: Gambro 1460
Status last verified: Jul 2025
First submitted: 13 Feb 2008
Last updated: 14 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 8305648
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.
PubMed 8573901

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Urea, Phosphate and b2-Microglobulin Removal and Ease of Use: Comparing the Polyflux HD-C4 With the Polyflux 210H
ClinicalTrials.gov ID: NCT00636389
Acronym / sponsor ID: Gambro 1460
Conditions: Chronic Kidney Disease
Keywords: Hemodialysis, Dialysis, Renal, Dialysis, Extracorporeal, Extracorporeal Dialysis
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Vantive Health LLCIndustry (pharma, biotech, devices)
Collaborators: Gambro Renal Products, Inc., Baxter Healthcare Corporation
Study start: Feb 2008
Primary completion: Dec 2008 (actual)
Study completion: Mar 2009 (actual)
First posted: 14 Mar 2008 (estimated)
Results: Posted 11 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
HD-C4 First, then 210H	Other	Device: Polyflux 210H dialyzer, Device: Polyflux HD-C4Subjects 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.
210H First, then HD-C4	Other	Device: Polyflux 210H dialyzer, Device: Polyflux HD-C4Subjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Polyflux 210H dialyzerAlso: Gambro Polyflux 210H dialyzerThree consecutive treatments with the Polyflux 210H dialyzer. All study treatments will be performed in the standard hemodialysis mode.	Device	210H First, then HD-C4, HD-C4 First, then 210H
Polyflux HD-C4Also: Gambro RevaclearThree consecutive treatments with the Polyflux HD-C4 dialyzer. All study treatments will be performed in the standard hemodialysis mode.	Device	210H First, then HD-C4, HD-C4 First, then 210H

Primary outcome

Comparison of Urea Removal Under Conditions of Routine Hemodialysis.
Time frame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments
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
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 11 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HD-C4 First (Period 1), Then 210H (Period 2)	7	7
210H First (Period 1), Then HD-C4 (Period 2)	5	5

Primary outcome: Comparison of Urea Removal Under Conditions of Routine Hemodialysis.

Time frame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments. Mean (Standard Deviation). Unit: ratio

Measure	HD-C4 n = 12	210H n = 12
Single-pool Kt/V Urea	1.64 (0.26)	1.61 (0.24)
Equilibrated Kt/V	1.42 (0.22)	1.40 (0.22)

Primary outcome: 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. Mean (Standard Deviation). Unit: Percentage of reduction

Measure	HD-C4 n = 12	210H n = 12
Urea Pre- to post-dialysis reduction (%)	74 (6)	74 (5)
Phosphorus Pre- to post-dialysis reduction (%)	61 (9)	60 (17)
b2-microglobulin Pre- to post-dialysis reduct (%)	52 (12)	58 (8)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 1 year, 1 month. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HD-C4 First (Period 1), Then 210H (Period 2)	0 of 7 (0%)	0 of 7 (0%)	Not reported
210H First (Period 1), Then HD-C4 (Period 2)	0 of 5 (0%)	0 of 5 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 8305648Daugirdas 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.
Background: PubMed 8573901Daugirdas 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Harry Alcorn Jr., PharmD principal investigator

Davita Clinical Research Facility

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Polyflux 210H dialyzer and Polyflux HD-C4 in people with Chronic Kidney Disease, run by Vantive Health LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Urea Removal Under Conditions of Routine Hemodialysis. (time frame: 2 weeks = duration required for each subject to complete 6 consecutive dialysis treatments). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00636389, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.