Chronic Kidney FailureNCT00659724

Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer

An observational study of Chronic Kidney Failure, run by Vantive Health LLC at 2 sites in United States.

Completed

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

Trial summary

The purpose of this study is to collect information on the ease of use and thrombogenicity of the Polyflux HD-C4 Big and Fresenius Optiflux 180NR or 200NR dialyzers under conditions of routine clinical use for hemodialysis. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Failure
How many people: 33 participants
Where: 2 sitesUnited States
Study dates: Mar 2008to May 2008
Phase: Observational
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

Study population: Assessment of dialyzer ease of use and thrombogenicity assessments following routine dialysis therapy of 33 adult patients (18 years of age or older)

Who may be able to join

Hemodialysis patients 18 years of age or older

Who cannot join

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Advanced Dialysis Center of Potomac
Arlington, Virginia, 22202-2714
Advanced Dialysis Center of Easton
Easton, Maryland, 21601

Other trials in United States

About this study

Official title: The Gambro Polyflux HD-C4 Big Ease Of Use And Thrombogenicity Study

Read the detailed description

This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is aimed at obtaining feedback from the nursing and technical staff regarding the use and thrombogenicity of the Polyflux HD-C4 Big, and Fresenius Optiflux 180NR or 200NR dialyzers. The dialysis nursing staff will complete ease of use and thrombogenicity assessments following routine dialysis therapy. Any adverse events will be tracked for the study patients.

Conditions: Chronic Kidney Failure
Keywords: Dialyzer
Medical subject headings: Kidney Failure, Chronic

What is being measured

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

Ease of Use: Priming Blood Side
For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows:
Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air.
Very Difficult:Air could not be removed.
Measured: Priming at each treatment
Ease of Use: Priming Dialysate Side
For every study treatment/dialyzer, the nursing staff rated the ease of priming dialysate side as follows:
Dialysate Side at 500 ml Priming Volume (check one):
Perfect: No air visible. Acceptable: Some air visible, but considered insignificant. Not Acceptable: Additional actions needed to sufficiently remove air.
Measured: Priming at each treatment
Dialyzer Assessment: Fiber Condition
For every study treatment/dialyzer, the nursing staff rated the condition of the dialyzer fibers after rinse-back as follows:
Very Good:All fibers appear white. Good:Few fibers (less than 10) appear PINK / RED. (check one) Poor:Several fibers (more than 10) appear PINK / RED. (check one) Very Poor:Most fibers (more than 75%) appear PINK / RED. (check one)
Measured: Each treatment: assessment of the condition of the dialyzer fibers after rinse-back
Dialyzer Assessment: Arterial Header Condition
For every study treatment/dialyzer, the nursing staff rated the condition of the arterial header after rinse-back as follows:
Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots.
Measured: Each treatment: assessment of the condition of the arterial header after rinse-back
Dialyzer Assessment: Venous Header Condition
For every study treatment/dialyzer, the nursing staff rated the condition of the venous header after rinse-back as follows:
Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots.
Measured: Each treatment: the assessment of the condition of the venous header after rinse-back

Timeline

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

Mar 2008May 2008

First posted16 Apr 2008 (estimated)
Study startMar 2008
Primary completionMay 2008
Study completionMay 2008

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.
Other trials for Chronic Kidney FailureStudies 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: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00659724
Sponsor's protocol ID: Gambro 1462
Status last verified: Jul 2025
First submitted: 14 Apr 2008
Last updated: 24 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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All Chronic Kidney Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Gambro Polyflux HD-C4 Big Ease Of Use And Thrombogenicity Study
ClinicalTrials.gov ID: NCT00659724
Acronym / sponsor ID: Gambro 1462
Conditions: Chronic Kidney Failure
Keywords: Dialyzer
Study type: Observational
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Vantive Health LLCIndustry (pharma, biotech, devices)
Collaborators: Advanced Dialysis Center of Potomac, Advanced Dialysis Center of Easton, Gambro Renal Products, Inc., Baxter Healthcare Corporation
Study start: Mar 2008
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 16 Apr 2008 (estimated)
Results: Posted 27 Jun 2011

Clinical summary

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

Detailed description

Study design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Assessment of dialyzer ease of use and thrombogenicity assessments following routine dialysis therapy of 33 adult patients (18 years of age or older)

Key inclusion criteria (1 listed)

Hemodialysis patients 18 years of age or older

Key exclusion criteria (1 listed)

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

Primary outcome

Ease of Use: Priming Blood Side
Time frame: Priming at each treatment
For every study treatment/dialyzer, the nursing staff rated the ease of priming blood side as follows: Very Easy:Air is easily removed without knocking or clamping procedures. Acceptable:Knocking and/or clamping required for efficient air removal. Difficult:Knocking and/or clamping and additional volume of saline or extended recirculation needed to remove air. Very Difficult:Air could not be removed.
Ease of Use: Priming Dialysate Side
Time frame: Priming at each treatment
For every study treatment/dialyzer, the nursing staff rated the ease of priming dialysate side as follows: Dialysate Side at 500 ml Priming Volume (check one): Perfect: No air visible. Acceptable: Some air visible, but considered insignificant. Not Acceptable: Additional actions needed to sufficiently remove air.
Dialyzer Assessment: Fiber Condition
Time frame: Each treatment: assessment of the condition of the dialyzer fibers after rinse-back
For every study treatment/dialyzer, the nursing staff rated the condition of the dialyzer fibers after rinse-back as follows: Very Good:All fibers appear white. Good:Few fibers (less than 10) appear PINK / RED. (check one) Poor:Several fibers (more than 10) appear PINK / RED. (check one) Very Poor:Most fibers (more than 75%) appear PINK / RED. (check one)
Dialyzer Assessment: Arterial Header Condition
Time frame: Each treatment: assessment of the condition of the arterial header after rinse-back
For every study treatment/dialyzer, the nursing staff rated the condition of the arterial header after rinse-back as follows: Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots.
Dialyzer Assessment: Venous Header Condition
Time frame: Each treatment: the assessment of the condition of the venous header after rinse-back
For every study treatment/dialyzer, the nursing staff rated the condition of the venous header after rinse-back as follows: Very Good:Surface as clean as expected. Good:Distinct red ring appears at the dialyzer wall. Poor:Significant appearance of clots, randomly distributed on the surface. Very Poor:Completely red and/or covered with clots.

Results and safety

Results posted to the registry on 27 Jun 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
Hemodialysis Patients	33	33

Primary outcome: Ease of Use: Priming Blood Side

Time frame: Priming at each treatment. Number. Unit: Number of Dialyzers

Measure	Revaclear MAX n = 33	Optiflux F180NR n = 33	Optiflux F200NR n = 33
Very Easy	139	13	13
Acceptable	80	82	84

Primary outcome: Ease of Use: Priming Dialysate Side

Time frame: Priming at each treatment. Number. Unit: Number of Dialyzers

Measure	Revaclear MAX n = 33	Optiflux F180NR n = 33	Optiflux F200NR n = 33
Perfect	131	4	2
Acceptable	89	91	95

Primary outcome: Dialyzer Assessment: Fiber Condition

Time frame: Each treatment: assessment of the condition of the dialyzer fibers after rinse-back. Number. Unit: Number of Dialyzers

Measure	Revaclear MAX n = 33	Optiflux F180NR n = 33	Optiflux F200NR n = 33
Very Good	126	23	15
Good	75	44	45
Poor	12	17	30
Very Poor	5	11	7

Primary outcome: Dialyzer Assessment: Arterial Header Condition

Time frame: Each treatment: assessment of the condition of the arterial header after rinse-back. Number. Unit: Number of Dialyzers

Measure	Revaclear MAX n = 33	Optiflux F180NR n = 33	Optiflux F200NR n = 33
Very Good	155	0	0
Good	49	66	64
Poor	13	26	30
Very Poor	1	3	2

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hemodialysis Patients	0 of 33 (0%)	0 of 33 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Kidney Failure

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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Not yet recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Kidney Failure, run by Vantive Health LLC at 2 sites 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 1 inclusion and 1 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 24 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 2 sites 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 27 Jun 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?

Ease of Use: Priming Blood Side (time frame: Priming at each treatment). The study lists 5 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 NCT00659724.

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 24 Jul 2025.