End Stage Renal DiseaseNCT02165761

Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients

A study testing GORE® Hybrid Vascular Graft and Non-heparin bonded synthetic graft in people with End Stage Renal Disease, run by W.L.Gore & Associates at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Disease
What is being tested?: GORE® Hybrid Vascular Graft and Non-heparin bonded synthetic graft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 4 sitesUnited States
Study dates: Jul 2014to 20 Jan 2017
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

The patient is not a candidate for a native fistula.
The patient requires the creation of an upper arm vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease.
The patient has been on hemodialysis for ≥1 month.

Who cannot join

The patient is scheduled for a different surgical procedure within 30 days post Index Procedure.
The patient has a known hypercoagulable disorder or bleeding disorder.
The patient has had a previous instance of Heparin Induced Thrombocytopenia Type II (HIT type II) or has known sensitivity to heparin.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Study site
Charlotte, North Carolina, 28207
Study site
Durham, North Carolina, 27710
Study site
Hackensack, New Jersey, 07601
Study site
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients Implanted With the GORE® Hybrid Vascular Graft Versus Non-heparin Bonded Synthetic Vascular Grafts.

Conditions: End Stage Renal Disease
Being tested: GORE® Hybrid Vascular Graft, Non-heparin bonded synthetic graft
Keywords: Hemodialysis, End Stage Renal Disease, Vascular Graft
Medical subject headings: Kidney Failure, Chronic

What participants receive

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

GORE® Hybrid Vascular GraftDevice
Non-heparin bonded synthetic graftDevice

Study groups in NCT02165761
Study group	Role	What they receive
GORE® Hybrid Vascular Graft	Active comparator	GORE® Hybrid Vascular Graft Receives: Device: GORE® Hybrid Vascular Graft
Non-heparin bonded synthetic graft	Other	Non-heparin bonded synthetic graft Receives: Device: Non-heparin bonded synthetic graft

What is being measured

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

Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points
Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM.
Measured: 14 days after index procedure

Timeline

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

Jul 201420 Jan 2017

First posted17 Jun 2014 (estimated)
Study startJul 2014
Primary completion20 Jan 2017
Study completion20 Jan 2017

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 End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02165761
Sponsor's protocol ID: HVG 13-01
Status last verified: Feb 2018
First submitted: 13 Jun 2014
Last updated: 19 Feb 2018
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 End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients Implanted With the GORE® Hybrid Vascular Graft Versus Non-heparin Bonded Synthetic Vascular Grafts.
ClinicalTrials.gov ID: NCT02165761
Acronym / sponsor ID: HVG 13-01
Conditions: End Stage Renal Disease
Keywords: Hemodialysis, End Stage Renal Disease, Vascular Graft
Study type: Interventional
Recruitment status: Terminated
Enrolment: 42 participants (actual)
Lead sponsor: W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: 20 Jan 2017 (actual)
Study completion: 20 Jan 2017 (actual)
First posted: 17 Jun 2014 (estimated)
Results: Posted 19 Feb 2018

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
GORE® Hybrid Vascular Graft	Active comparator	Device: GORE® Hybrid Vascular GraftGORE® Hybrid Vascular Graft
Non-heparin bonded synthetic graft	Other	Device: Non-heparin bonded synthetic graftNon-heparin bonded synthetic graft

Who may qualify

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

Key inclusion criteria (3 listed)

The patient is not a candidate for a native fistula.
The patient requires the creation of an upper arm vascular access graft for hemodialysis secondary to a diagnosis of End-Stage Renal Disease.
The patient has been on hemodialysis for ≥1 month.

Key exclusion criteria (3 listed)

The patient is scheduled for a different surgical procedure within 30 days post Index Procedure.
The patient has a known hypercoagulable disorder or bleeding disorder.
The patient has had a previous instance of Heparin Induced Thrombocytopenia Type II (HIT type II) or has known sensitivity to heparin.

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
GORE® Hybrid Vascular Graft	Device	GORE® Hybrid Vascular Graft
Non-heparin bonded synthetic graft	Device	Non-heparin bonded synthetic graft

Primary outcome

Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points
Time frame: 14 days after index procedure
Antibody screening was performed using a commercial poly-specific EIA that detects antibodies of any of the IgG, IgA, and / or IgM classes against PF4/polyvinyl sulfonate complexes, the EIA-GAM.

Results and safety

Results posted to the registry on 19 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GORE® Hybrid Vascular Graft	23	4
Non-heparin Bonded Synthetic Graft	19	5

Primary outcome: Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points

Time frame: 14 days after index procedure. Count of participants. Unit: Participants

Measure	GORE® Hybrid Vascular Graft n = 19	Non-heparin Bonded Synthetic Graft n = 16
Value	3	2

Population analysed: In the GORE® Hybrid Vascular Graft Group 19 out of 23 participants had obtained a serology sample at Day 7 and/or Day 14 for analysis. In the Non-heparin bonded synthetic graft Group 16 out of 19 participants had obtained a serology sample at Day 7 and/or Day 14 for analysis.

Adverse events

Time frame: 2 years, 3 months. Other adverse events reported at 5.0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hybrid Vascular Graft (Test)	6 of 23 (26.1%)	4 of 23 (17.4%)	1 of 23
Non-Heparin Synthetic Graft (Control)	5 of 19 (26.3%)	8 of 19 (42.1%)	1 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
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RecruitingPhase 1
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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing GORE® Hybrid Vascular Graft and Non-heparin bonded synthetic graft in people with End Stage Renal Disease, run by W.L.Gore & Associates at 4 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 3 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: stopped early, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 19 Feb 2018). 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?

Number of Participants With a Prevalence of a Positive Poly-specific Enzyme Immunoassay (EIA) at Day 7 and/or Day 14 Time Points (time frame: 14 days after index procedure). 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 NCT02165761.

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 19 Feb 2018.