End-stage Renal DiseasePRICENCT01601873

Propaten Randomized Investigation on Cost-benefit and Efficacy

A study testing PROPATEN and Standard Graft in people with End-stage Renal Disease, run by The University of Texas Health Science Center, Houston at 5 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

The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease. 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?: PROPATEN and Standard Graft
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 103 participants
Where: 5 sitesUnited States
Study dates: 9 Nov 2012to 30 Jun 2018
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

Aged ≥18 years of all ethnicities
End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR <15ml/min 1.73m2) per National Kidney Foundation guidelines
Currently undergoing hemodialysis with a failure of previous access
Expected to undergo hemodialysis within 6 months of presentation

Who cannot join

Unable/refuse to abide with follow-up
Known hypercoagulability syndrome or a bleeding disorder
On a previous anticoagulant treatment
Intraoperative decision in favor of fistula instead of graft
Pregnant or breast-feeding women
A documented history of heparin induced thrombocytopenia or allergy
Active infections
Evidence or suspicion of central vein stenosis

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Department of Cardiothoracic and Vascular Surgery and Memorial Hermann Heart and Vascular Institute - Texas Medical Center
Houston, Texas, 77030
Department of Cardiothoracic and Vascular Surgery; Memorial Hermann Hospital Southeast
Houston, Texas, 77089
University of Arkansas for Medical Sciences (UAMS) & Central Arkansas Veterans Healthcare System (CAVHS)
Little Rock, Arkansas, 72205
John Ochsner Heart & Vascular Institute Ochsner Medical Center
New Orleans, Louisiana, 70121

Other trials in United States

About this study

Official title: A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Heparin-bonded Versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts.

The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.

Read the detailed description

Study Design: This is a prospective, multi-institution, parallel-group, single-blinded, randomized-controlled, two-arm, effectiveness study comparing heparin-bonded (Propaten®) versus non-heparin-bonded arteriovenous grafts.

Procedure: In patients without usable native vein, prosthetic arteriovenous grafts will be implanted for hemodialysis access. Patients will be randomized intraoperatively to either conventional (Gore® Stretch) or heparin-bonded grafts (Gore® Propaten).

Course of Study: The study will accrue patients over the course of 5 years.

Enrollment: Enrollment will consist of adult patients who require hemodialysis. If the patient cannot have a native vein arteriovenous fistula, the patient is a candidate for arteriovenous graft. Patients will be screened and consented preoperatively. If the intraoperative decision is made that the patient will require a graft, randomization will occur and the patient will be considered enrolled.

Recruitment: The target population comprises of all adult patients aged 18 years and above with end stage renal disease requiring arteriovenous access for hemodialysis. The target for enrollment will be 200 patients.

Risks: The standard or known adverse events associated with graft implantation include thrombosis, infection, pseudoaneurysm, hematoma, and venous stenosis. There are case reports of heparin sensitivity. The investigators do not expect any additional physical risks other than an unintentional disclosure of sensitive patient health information.

Data Safety Monitoring: As the Principal Investigator of this study, Dr. Charlton-Ouw from the Department of Cardiothoracic and Vascular Surgery at The University of Texas at Houston Medical School will conduct the data safety monitoring of this study. He will annually meet with all other co-investigators to review the patients enrolled in this study. As part of the data safety monitoring plan, all patients enrolled until that point in time would be unblinded in order to review the outcomes. Interim analyses will be conducted at the one-year follow up time.

IND#: The devices that will be used are already approved by the FDA and do not have IND#.

Proposed Funding Source: The study is internally funded.

Communication of Study Results: The communication of study results will occur only between authorized individuals who are listed to take part in the study through our department. The individuals who will take part in the study will acknowledge and adhere to the importance of patient safety and the protection of their private information. The results of this study will be analyzed and published after the approval of the principal investigator, co-investigators, and biostatistician in a peer-reviewed scientific journal and/or presented at an international/national scientific conference or meeting regardless of outcome.

Conditions: End-stage Renal Disease
Being tested: PROPATEN, Standard Graft
Keywords: Arteriovenous graft, Propaten, Heparin-bonded, hemodialysis vascular access, Surgical, Arteriovenous Shunt
Medical subject headings: Kidney Failure, Chronic, Arteriovenous Fistula

What participants receive

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

PROPATENDevice
Also called Heparin-bonded hemodialysis graft
Heparin-bonded graft implantation for hemodialysis vascular access
Standard GraftDevice
Also called Conventional ePTFE hemodialysis graft
non-heparin bonded conventional hemodialysis vascular access graft

Study groups in NCT01601873
Study group	Role	What they receive
PROPATEN	Experimental	patients with heparin-bonded graft implantation Receives: Device: PROPATEN
Standard Graft	Active comparator	patients undergoing ePTFE hemodialysis graft implantation Receives: Device: Standard Graft

What is being measured

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

Primary Graft Patency Rate
Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.
Measured: 12 months
Primary-Assisted Graft Patency Rate
Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.
Measured: 12 months
Secondary Graft Patency Rate
Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.
Measured: 12 months
Primary Graft Patency Rate
Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.
Measured: 24 months after graft placement
Primary-Assisted Graft Patency Rate
Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.
Measured: 24 months after graft placement
Secondary Graft Patency Rate
Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.
Measured: 24 months after graft placement

Secondary outcomes (4)

Number of Participants With Complications or Morbidity Attributable to the Study
Complication/morbidity associated with both types of interventions
Measured: at least 1 year but up to two years
Cost Estimation and Analysis
Will be based on the difference between total cost analysed on the basis of the specific graft price, cost of re-intervention procedures if any, treatment of complications, hospital stay, etc., and compared for each study arm.
Measured: During the study period based on an average participant follow-up of 2 years after graft placement
Quality of Life (QoL) Comparison
Comparative assessment of quality of life reported by the patients in two arms
Measured: Participants would be followed for a period of 2 years after graft placement
Number of Postoperative Re-interventions
Measured: at least 1 year but up to two years

Timeline

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

9 Nov 201230 Jun 2018

First posted18 May 2012 (estimated)
Study start9 Nov 2012
Primary completion31 Dec 2017
Study completion30 Jun 2018

Why it stopped: Results from futility analysis conducted at planned interim time-point did not meet the study criteria for continuation.

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 (1)Papers the sponsor has linked to this study.
Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01601873
Sponsor's protocol ID: CTVS-KC01
Other IDs: UTHSCMS-12/0095
Acronym: PRICE
Status last verified: Jan 2019
First submitted: 16 May 2012
Last updated: 27 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided: De-identified data will be available following institutional review board approval

Publications

Charlton-Ouw KM, Nosrati N, Miller CC 3rd, Coogan SM, Safi HJ, Azizzadeh A. Outcomes of arteriovenous fistulae compared with heparin-bonded and conventional grafts for hemodialysis access. J Vasc Access. 2012 Apr-Jun;13(2):163-7. doi: 10.5301/JVA.2011.8715.
PubMed 21983827

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 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Comparative Study on Efficacy and Cost-effectiveness of Heparin-bonded Versus Non-heparin-bonded Polytetrafluroethylene Hemodialysis Access Grafts.
ClinicalTrials.gov ID: NCT01601873
Acronym / sponsor ID: PRICE / CTVS-KC01
Conditions: End-stage Renal Disease
Keywords: Arteriovenous graft, Propaten, Heparin-bonded, hemodialysis vascular access, Surgical, Arteriovenous Shunt
Study type: Interventional
Recruitment status: TerminatedReason stopped: Results from futility analysis conducted at planned interim time-point did not meet the study criteria for continuation.
Enrolment: 103 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Collaborators: University Hospitals Cleveland Medical Center, University of Arkansas, Ochsner Health System
Study start: 9 Nov 2012 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 18 May 2012 (estimated)
Results: Posted 27 Feb 2019

Clinical summary

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

The purpose for this study is to evaluate the patency and outcomes of conventional and heparin anticoagulant bonded arteriovenous grafts in patients with end stage renal disease.

Detailed description

Course of Study: The study will accrue patients over the course of 5 years.

IND#: The devices that will be used are already approved by the FDA and do not have IND#.

Proposed Funding Source: The study is internally funded.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PROPATEN	Experimental	Device: PROPATENpatients with heparin-bonded graft implantation
Standard Graft	Active comparator	Device: Standard Graftpatients undergoing ePTFE hemodialysis graft implantation

Who may qualify

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

Key inclusion criteria (4 listed)

Aged ≥18 years of all ethnicities
End-stage Renal Disease stage 4 (GFR 15-29 ml/min 1.73m2) or stage 5 (GFR <15ml/min 1.73m2) per National Kidney Foundation guidelines
Currently undergoing hemodialysis with a failure of previous access
Expected to undergo hemodialysis within 6 months of presentation

Key exclusion criteria (8 listed)

Unable/refuse to abide with follow-up
Known hypercoagulability syndrome or a bleeding disorder
On a previous anticoagulant treatment
Intraoperative decision in favor of fistula instead of graft
Pregnant or breast-feeding women

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
PROPATENAlso: Heparin-bonded hemodialysis graftHeparin-bonded graft implantation for hemodialysis vascular access	Device	PROPATEN
Standard GraftAlso: Conventional ePTFE hemodialysis graftnon-heparin bonded conventional hemodialysis vascular access graft	Device	Standard Graft

Primary outcome

Primary Graft Patency Rate
Time frame: 12 months
Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.
Primary-Assisted Graft Patency Rate
Time frame: 12 months
Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.
Secondary Graft Patency Rate
Time frame: 12 months
Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.
Primary Graft Patency Rate
Time frame: 24 months after graft placement
Primary graft patency refers to the successful use of a vascular access for hemodialysis without any surgical or endovascular intervention.
Primary-Assisted Graft Patency Rate
Time frame: 24 months after graft placement
Primary-assisted graft patency is defined as a patent access with evidence of malfunction that requires an open surgical or endovascular intervention.
Secondary Graft Patency Rate
Time frame: 24 months after graft placement
Secondary graft patency is defined as a functional access following intervention for thrombosis or after any interposition grafting for any reason including stenosis, aneurysm or pseudoaneurysm.

4 secondary outcomes

Number of Participants With Complications or Morbidity Attributable to the Study
Time frame: at least 1 year but up to two years
Cost Estimation and Analysis
Time frame: During the study period based on an average participant follow-up of 2 years after graft placement
Quality of Life (QoL) Comparison
Time frame: Participants would be followed for a period of 2 years after graft placement
Number of Postoperative Re-interventions
Time frame: at least 1 year but up to two years

Results and safety

Results posted to the registry on 27 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PROPATEN	50	48
Standard Graft	47	44

Primary outcome: Primary Graft Patency Rate

Time frame: 12 months. Number. Unit: Percentage of participants

Measure	PROPATEN n = 49	Standard Graft n = 44
Value	35	33

PROPATEN vs Standard Graft: p = 0.884, Wilcoxon (Mann-Whitney)

Population analysed: 1 in the propaten arm and 3 in the standard graft arm were lost to follow up.

Primary outcome: Primary-Assisted Graft Patency Rate

Time frame: 12 months. Number. Unit: Percentage of participants

Measure	PROPATEN n = 49	Standard Graft n = 44
Value	57	60

PROPATEN vs Standard Graft: p = 0.946, Wilcoxon (Mann-Whitney)

Population analysed: 1 in the propaten arm and 3 in the standard graft arm were lost to follow up.

Primary outcome: Secondary Graft Patency Rate

Time frame: 12 months. Number. Unit: Percentage of participants

Measure	PROPATEN n = 49	Standard Graft n = 44
Value	62	52

PROPATEN vs Standard Graft: p = 0.294, Wilcoxon (Mann-Whitney)

Population analysed: 1 in the propaten arm and 3 in the standard graft arm were lost to follow up.

Primary outcome: Primary Graft Patency Rate

Time frame: 24 months after graft placement. Number. Unit: Percentage of participants

Measure	PROPATEN n = 48	Standard Graft n = 44
Value	24	25

PROPATEN vs Standard Graft: p = 0.538, Log Rank

Population analysed: 2 in the propaten group and 3 in the standard graft group were lost to follow up.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: At least 1 year but up to two years (the study was stopped early for futility; therefore, some subjects were only followed for a year). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PROPATEN	0 of 48 (0%)	19 of 48 (39.6%)	7 of 48
Standard Graft	0 of 44 (0%)	20 of 44 (45.5%)	4 of 44

Limitations and caveats (from the sponsor): The trial was stopped early for futility based on a pre-planned interim analysis and a Bayesian probability forecast incorporating all available information from a recent meta-analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21983827Charlton-Ouw KM, Nosrati N, Miller CC 3rd, Coogan SM, Safi HJ, Azizzadeh A. Outcomes of arteriovenous fistulae compared with heparin-bonded and conventional grafts for hemodialysis access. J Vasc Access. 2012 Apr-Jun;13(2):163-7. doi: 10.5301/JVA.2011.8715.
Individual participant dataSharing planned: Undecided. De-identified data will be available following institutional review board approval

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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.

Kristofer M Charlton-Ouw, MD principal investigator

University of Texas Health Science Center, UT Medical School Department of Cardiothoracic and Vascular Surgery, Houston

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

Questions about this trial

What is this clinical trial studying?

A study testing PROPATEN and Standard Graft in people with End-stage Renal Disease, run by The University of Texas Health Science Center, Houston at 5 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 4 inclusion and 8 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 Feb 2019). 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?

Primary Graft Patency Rate (time frame: 12 months). The study lists 6 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 NCT01601873, which also lists 1 linked publication.

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 27 Feb 2019.