Kidney Failure, ChronicNCT00836862
Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens
An observational study of Kidney Failure, Chronic, run by University of Nebraska at 1 site in United States.
Trial summary
This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Biologic specimens
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2009to 7 Sep 2017
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be eligible if they are 19 years of age or greater and have placement of an arteriovenous fistula planned witin 30 days.
Who may be able to join
- Age 19 years of age or greater
- Arteriovenous fistula placement for hemodialysis access scheduled within 30 days
Who cannot join
- Incompetent to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.
Read the detailed description
Hemodialysis patients utilizing an arteriovenous fistula (AVF) for hemodialysis access are 10 times less likely to develop bacteremia than those patients utilizing a hemodialysis catheter. Because of this, a great focus has been on placing AVF in all patients undergoing hemodialysis. While AVF are relatively simple to place from a surgical standpoint, 30-60% of AVF will not mature adequately to be used for hemodialysis. In order to be utilized for hemodialysis, the blood flow in the vein used to create the AVF will need to increase by over 100 fold. In order to do so, the vein will need to dilate by more than 150%. AVF which fail to mature do not dilate, and the major histologic finding in these AVF has been neointimal hyperplasia. The factors (both circulating and tissue) which contribute to AVF maturation or failure are poorly understood, and investigations in this area are limited. Current studies in the literature have either described pre-AVF vein characteristics, or have looked at serum or tissue specimens following AVF failure. To date, no studies have looked at specimens from patients both before and after fistula placement, or described factors associated with fistula maturation. This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Biologic specimens
- Keywords
- Hemodialysis, Vascular access, Arteriovenous fistula
- 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.
Biologic specimensOther
Banking of serum, DNA and tissue
| Study group | Role | What they receive |
|---|---|---|
| Arteriovenous Fistula | A tissue bank will be created to collect serum, whole blood, and vein specimens obtained from participants undergoing Arteriovenous Fistula (AVF) placement and revision. The planned specimen harvests will allow for both pre- and post-AVF placement specimens from both maturing and failing AVF. Receives: Other: Biologic specimens |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study start1 Feb 2009
- Primary completion10 Nov 2012
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Troy J Plumb, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836862
- Sponsor's protocol ID
- 0482-08-EP
- Status last verified
- Dec 2023
- First submitted
- 3 Feb 2009
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arteriovenous Fistula Tissue Bank for Pre- and Post-Fistula Placement Specimens
- ClinicalTrials.gov ID
- NCT00836862
- Acronym / sponsor ID
- 0482-08-EP
- Conditions
- Kidney Failure, Chronic
- Keywords
- Hemodialysis, Vascular access, Arteriovenous fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 1 Feb 2009 (actual)
- Primary completion
- 10 Nov 2012 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 4 Feb 2009 (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.
This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.
Detailed description
Hemodialysis patients utilizing an arteriovenous fistula (AVF) for hemodialysis access are 10 times less likely to develop bacteremia than those patients utilizing a hemodialysis catheter. Because of this, a great focus has been on placing AVF in all patients undergoing hemodialysis. While AVF are relatively simple to place from a surgical standpoint, 30-60% of AVF will not mature adequately to be used for hemodialysis. In order to be utilized for hemodialysis, the blood flow in the vein used to create the AVF will need to increase by over 100 fold. In order to do so, the vein will need to dilate by more than 150%. AVF which fail to mature do not dilate, and the major histologic finding in these AVF has been neointimal hyperplasia. The factors (both circulating and tissue) which contribute to AVF maturation or failure are poorly understood, and investigations in this area are limited. Current studies in the literature have either described pre-AVF vein characteristics, or have looked at serum or tissue specimens following AVF failure. To date, no studies have looked at specimens from patients both before and after fistula placement, or described factors associated with fistula maturation. This project will bank sera, DNA and vascular specimens from patients undergoing arteriovenous fistula creation and revision.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arteriovenous Fistula | – | Other: Biologic specimensA tissue bank will be created to collect serum, whole blood, and vein specimens obtained from participants undergoing Arteriovenous Fistula (AVF) placement and revision. The planned specimen harvests will allow for both pre- and post-AVF placement specimens from both maturing and failing AVF. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be eligible if they are 19 years of age or greater and have placement of an arteriovenous fistula planned witin 30 days.
Key inclusion criteria (2 listed)
- Age 19 years of age or greater
- Arteriovenous fistula placement for hemodialysis access scheduled within 30 days
Key exclusion criteria (1 listed)
- Incompetent to provide informed consent
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 |
|---|---|---|
| Biologic specimensBanking of serum, DNA and tissue | Other | Arteriovenous Fistula |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
Related trials for Kidney Failure, Chronic
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
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Troy J Plumb, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic, run by University of Nebraska 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 2 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 28 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 28 Dec 2023.