End-Stage Renal DiseasePhase 2NCT00179192
Prevention and Treatment of Hemodialysis Vascular Access Malfunction
A Phase 2 study testing angioplasty and surgery in people with End-Stage Renal Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End-Stage Renal Disease
- What is being tested?
- angioplasty and surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 1998to Oct 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with End Stage Renal Disease on chronic maintenance hemodialysis 3 times per week
- Have an arteriovenous (polytetrafluoroethylene) graft as vascular access
- Have a venous stenosis between 30% and 70% as determined by angiogram
Who cannot join
- Native arteriovenous fistula
- Known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries >4
- Unwilling to participate
- Allergy to iodine
- Absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery)
- Known arterial limb stenosis or long vessel length venous stenosis which are unamenable to surgical or angioplasty techniques, respectively, and therefore prohibit randomization
- Known hypercoagulable state
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses.
It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.
- Conditions
- End-Stage Renal Disease
- Being tested
- angioplasty, surgery
- Keywords
- End Stage Renal Disease, ESRD, Chronic Maintenance Hemodialysis
- 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.
angioplastyProcedure or surgery
angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist
surgeryProcedure or surgery
surgical revision of patient's PTFE in a timely fashion not to exceed 72-96 hours after the angiogram; method of revision to be determined by the surgeon performing the procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | control group |
| 2 | Active comparator | angioplasty intervention Receives: Procedure: angioplasty |
| 3 | Active comparator | surgery intervention Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the hypothesis that early intervention of a vascular access determined to be at increased risk of malfunction and thrombosis improves the long-term access outcome versus standard of care.
Measured: 2 years
Secondary outcomes (1)
To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMay 1998
- Primary completionOct 2006
- Study completionOct 2006
Why it stopped: non-enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Ikizler, Vanderbilt University
- Investigators
- Talat A Ikizler, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179192
- Sponsor's protocol ID
- 9318
- Status last verified
- May 2015
- First submitted
- 13 Sep 2005
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Hemodialysis Vascular Access Malfunction
- ClinicalTrials.gov ID
- NCT00179192
- Acronym / sponsor ID
- 9318
- Conditions
- End-Stage Renal Disease
- Keywords
- End Stage Renal Disease, ESRD, Chronic Maintenance Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: non-enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- May 1998
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses.
It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –control group |
| 2 | Active comparator | Procedure: angioplastyangioplasty intervention |
| 3 | Active comparator | Procedure: surgerysurgery intervention |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with End Stage Renal Disease on chronic maintenance hemodialysis 3 times per week
- Have an arteriovenous (polytetrafluoroethylene) graft as vascular access
- Have a venous stenosis between 30% and 70% as determined by angiogram
Key exclusion criteria (7 listed)
- Native arteriovenous fistula
- Known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries >4
- Unwilling to participate
- Allergy to iodine
- Absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery)
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 |
|---|---|---|
| angioplastyangioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist | Procedure or surgery | 2 |
| surgerysurgical revision of patient's PTFE in a timely fashion not to exceed 72-96 hours after the angiogram; method of revision to be determined by the surgeon performing the procedure | Procedure or surgery | 3 |
Primary outcome
To test the hypothesis that early intervention of a vascular access determined to be at increased risk of malfunction and thrombosis improves the long-term access outcome versus standard of care.
Time frame: 2 years
1 secondary outcome
To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2015.
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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.
Talat A Ikizler, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing angioplasty and surgery in people with End-Stage Renal Disease, run by Vanderbilt University 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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 25 May 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To test the hypothesis that early intervention of a vascular access determined to be at increased risk of malfunction and thrombosis improves the long-term access outcome versus standard of care. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2015.