AV FistulaFAV-2019NCT06815159
Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis
A study testing Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis. in people with AV Fistula, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AV Fistula
- What is being tested?
- Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 18 Mar 2020to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age greater than or equal to 18 years;
- Patients candidates for first AVF for hemodialysis or correction of AVF complication, as part of the normal care pathway;
- Obtaining informed consent signed by the patient
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS AOU di Bologna Policlinico di Sant'Orsola
Bologna, 40138
Mauro Prof Gargiulo, MD, 0512143288, mauro.gargiulo2@unibo.it
About this study
The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.
POPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to reoperation for correction of complication and/or new AVF by proximalization, as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.
Read the detailed description
The following study will enroll two cohorts of patients: 75 patients from Population 1 and 75 patients from Population 2, according to the inclusion criteria. Since this is an exploratory study, this number is considered sufficient to observe and compare tissue markers associated with early AVF stenosis.
Patients will be treated according to clinical practice in accordance with the physician's judgment.
The study includes: the recruitment of patients from the two study populations, the obtaining of the surgical specimen from both populations and its sending to the Pathology Department, as part of the normal care pathway, the execution of three tissue samples at the Pathology Department: (i) a sample frozen in liquid nitrogen and stored in an ultrafreezer at -80°C for RT-PCR analysis; (ii) a sample placed in PBS for cell culture; (iii) the remainder of the sample fixed in formalin, embedded in paraffin and processed according to the normal care pathway and histological diagnosis. 2 µm slices will be cut from the paraffin block for histological staining and histochemical and IIC investigations; execution of cell culture investigations and execution of RT-PCR investigations.
- Conditions
- AV Fistula
- Being tested
- Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.Biological
Primary objective
- Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis. Secondary objectives
- Compare the results on the possible different expression of tissue markers before and during dialysis.
- Compare the results on the possible different expression of tissue markers between AVFs made with portions of cephalic vein and AVFs made with portions of basilic vein, in order to evaluate whether the different topographic origin of the AVF can influence its duration.
| Study group | Role | What they receive |
|---|---|---|
| First FAV | Experimental | Group of patient with first FAV Receives: Biological: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis. |
| Secondary FAV | Experimental | Group of patients with reintervention of FAV Receives: Biological: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.
Biomarkers of the treated fistula are histologically examined
Measured: From the first patient entrolled, up to the 150th patient, an average of 6 years
Secondary outcomes (2)
Different expression of tissue markers before and during dialysis.
Markers expression of the treated tissue are analysed and compared between the two study group.
Measured: From the first patient enrolled to the 150th patient, an average of 6 years
Markers differences between Basilic and cephalic vein
Compare the results on the possible different expression of tissue markers between AVFs made with portions of cephalic vein and AVFs made with portions of basilic vein, in order to evaluate whether the different topographic origin of the AVF can influence its duration.
Measured: From the first patient enrolled, up to the 150th patient, up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start18 Mar 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AV FistulaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery POPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to re-intervention for correction of complication and/or new AVF by proximalization,
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mauro Gargiulo, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06815159
- Sponsor's protocol ID
- FAV-2019
- Acronym
- FAV-2019
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 7 Feb 2025
- 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 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Markers Predictive of Early Stenosis in the Arterovenous Fistula for Hemodialysis
- ClinicalTrials.gov ID
- NCT06815159
- Acronym / sponsor ID
- FAV-2019 / FAV-2019
- Conditions
- AV Fistula
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 18 Mar 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Feb 2025 (actual)
- 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.
The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.
POPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to reoperation for correction of complication and/or new AVF by proximalization, as part of the normal care pathway, at the Metropolitan Vascular Surgery Unit, Dir. Prof. Mauro Gargiulo of the S.Orsola-Malpighi University Hospital.
Detailed description
The following study will enroll two cohorts of patients: 75 patients from Population 1 and 75 patients from Population 2, according to the inclusion criteria. Since this is an exploratory study, this number is considered sufficient to observe and compare tissue markers associated with early AVF stenosis.
Patients will be treated according to clinical practice in accordance with the physician's judgment.
The study includes: the recruitment of patients from the two study populations, the obtaining of the surgical specimen from both populations and its sending to the Pathology Department, as part of the normal care pathway, the execution of three tissue samples at the Pathology Department: (i) a sample frozen in liquid nitrogen and stored in an ultrafreezer at -80°C for RT-PCR analysis; (ii) a sample placed in PBS for cell culture; (iii) the remainder of the sample fixed in formalin, embedded in paraffin and processed according to the normal care pathway and histological diagnosis. 2 µm slices will be cut from the paraffin block for histological staining and histochemical and IIC investigations; execution of cell culture investigations and execution of RT-PCR investigations.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study involves the recruitment of two populations. POPULATION 1 (surgical sample of excess venous segment): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to first AVF surgery POPULATION 2 (surgical sample of arterialized venous segment from removal of previous AVF): at least 75 consecutive patients, enrolled according to the inclusion criteria and subjected to re-intervention for correction of complication and/or new AVF by proximalization,
| Arm | Type | Receives |
|---|---|---|
| First FAV | Experimental | Biological: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.Group of patient with first FAV |
| Secondary FAV | Experimental | Biological: Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.Group of patients with reintervention of FAV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than or equal to 18 years;
- Patients candidates for first AVF for hemodialysis or correction of AVF complication, as part of the normal care pathway;
- Obtaining informed consent signed by the patient
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis.Primary objective 1. Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis. Secondary objectives 2. Compare the results on the possible different expression of tissue markers before and during dialysis. 3. Compare the results on the possible different expression of tissue markers between AVFs made with portions of cephalic vein and AVFs made with portions of basilic vein, in order to evaluate whether the different topographic origin of the AVF can influence its duration. | Biological | First FAV, Secondary FAV |
Primary outcome
Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis.
Time frame: From the first patient entrolled, up to the 150th patient, an average of 6 years
Biomarkers of the treated fistula are histologically examined
2 secondary outcomes
Different expression of tissue markers before and during dialysis.
Time frame: From the first patient enrolled to the 150th patient, an average of 6 years
Markers differences between Basilic and cephalic vein
Time frame: From the first patient enrolled, up to the 150th patient, up to 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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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.
Mauro Gargiulo, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Identification any tissue markers predictive or favoring early stenosis in AVF for haemodialysis. in people with AV Fistula, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 0 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: looking for participants now, as of the sponsor's last update on 7 Feb 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mauro Gargiulo, MD (0512143288, mauro.gargiulo2@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify any predictive or favoring tissue markers of early stenosis in AVF for hemodialysis. (time frame: From the first patient entrolled, up to the 150th patient, an average of 6 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 7 Feb 2025.