Complication of Renal DialysisPhase 3ACCESS2NCT05425056
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
A Phase 3 study testing Sirolimus in people with Complication of Renal Dialysis and End Stage Renal Disease, run by Vascular Therapies, Inc. at 22 sites in 2 countries.
Trial summary
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease
- What is being tested?
- Sirolimus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 22 sitesin 2 countries
- Study dates
- 26 Aug 2022to 29 Aug 2025
- Phase
- Phase 3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65 years or older
- Currently on hemodialysis for ≤12 months
- Successful creation of a single stage radiocephalic end to side fistula
Who cannot join
- Prior AV access created on the limb where the fistula surgery is planned
- Planned start of peritoneal dialysis within 6 months of randomization
- Known hypersensitivity to the following: sirolimus, beef or bovine collagen
- Known to be HIV positive
- Prisoner, mentally incompetent, and/or current alcohol or drug abuser
Trial locations and contacts
22 sites in 2 countries.
22 sites in 2 countries
United States17 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Augusta University
Augusta, Georgia, 30912
The Brigham and Women's Hospital
Boston, Massachusetts, 02115
Atrium Health
Charlotte, North Carolina, 28204
Surgical Specialists of Charlotte
Charlotte, North Carolina, 28207
Arteries & Veins
El Paso, Texas, 79912
Houston Methodist
Houston, Texas, 77030
University of Louisville
Louisville, Kentucky, 40202
James Eric Gardner, MD PC
Memphis, Tennessee, 38115
American Access Care of Miami
Miami, Florida, 33156
Mount Sinai Hospital
New York, New York, 10029
Sentara Norfolk General Hospital/Sentara Health Research Center
Norfolk, Virginia, 23507
The Regional Medical Center/Dialysis Access Institute
Orangeburg, South Carolina, 29118
Veterans Affairs San Diego Health Center
San Diego, California, 92161
Houston Methodist
Sugar Land, Texas, 77479
Lundquist Institute for Biomedical Innovation
Torrance, California, 90502
MedStar Cardiovascular Research Network at MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
United Kingdom5 sites
University Hospitals Birmingham NHS Foundation Trust
Birmingham
St Helier Hospital
Carshalton, SM5 1AA
NHS Greater Glasgow and Clyde
Glasgow
Barts Health NHS Trust of Royal London Hospital
London
St George's University Hospitals NHS Foundation Trust
London
About this study
Official title: A Phase 3, Prospective, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus Eluting Collagen Implant (The ACCESS 2 Trial)
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.
Read the detailed description
This is a Phase 3, multicenter, randomized, single-blind, controlled, study designed to evaluate the efficacy and safety of the use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects who are on hemodialysis and are undergoing surgical creation of an AV fistula in comparison to subjects who do not receive the implant.
Subjects of either gender, who are at least 65 years of age, undergoing hemodialysis, and require a new single stage radiocephalic end to side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation will be eligible for enrollment. The study plans to enroll approximately 120 subjects, randomized in a 1:1 ratio. Enrolled subjects will be followed for a period of one year from the time of their index surgical procedure.
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD, Chronic Kidney Failure, Complication of Hemodialysis
- Being tested
- Sirolimus
- Keywords
- Arteriovenous Fistula, Hemodialysis vascular access, Dialysis fistula, Dialysis access
- 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.
SirolimusDrug
Also called Sirolimus-eluting Collagen Implant, SeCI, Sirogen
SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI). Receives: Drug: Sirolimus |
| Control Arm | No intervention | Subjects randomized to the control arm will undergo AV fistula surgery alone and will not receive an implant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Clinical Fistula Maturation (FM)
Clinical Fistula Maturation (FM) is defined as a fistula that can be cannulated with 2-needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of 300 mL/min (unless the prescribed Qb is <300 mL/min) performed during any continuous 30 day period that commences no later than 180 days after randomization.
FM will be summarized by plotting the (inverted) Kaplan-Meier (KM) curves for the treatment and control groups. The KM proportions (and associated 95% CIs) for FM for the two groups will be evaluated on day 210.
Measured: 6 Months
Secondary outcomes (7)
Fistula Suitability for Dialysis at 12 Months (FSD12)
Fistula Suitability for Dialysis at 12 months (FSD12) defined as a fistula that can be used for dialysis using 2 needles for at least 75% of the dialysis sessions performed during a 30 day period that commences on day 330.
Measured: 1 year
Percentage of Participants With Secondary Patency at 12 Months
Secondary Patency (SP) defined as the interval from the time of randomization until access abandonment. SP will be summarized as the cumulative proportion of abandoned AVF by plotting the (inverted SP) Kaplan-Meier (KM) curves for each treatment group and estimating the KM proportions (and associated 95% CIs) of AVF that have maintained SP by day 360 or end of study visit (whichever is later).
Measured: 12 Months
Percentage of Participants With First Dialysis (TTFD) at 12 Months
Time To First Dialysis (TTFD) defined as the interval from the time of randomization to the first of three consecutive dialysis sessions using 2 needles with a mean Qb of ≥300 mL/min (unless the prescribed Qb is <300 mL/min). TTFD will be summarized by plotting the (inverted) Kaplan-Meier (KM) curves for each group (treatment and controls) and estimating the KM proportions (and associated 95% CIs) achieving first dialysis by day 360.
TTFD will be summarized by plotting the (inverted) Kaplan-Meier (KM) curves for the treatment and control groups. The TTFD proportions (and associated 95% CIs) for TTFD for the two groups will be evaluated on day 360.
Measured: 12 Months
Percentage of Participants With Mature Fistula With Preserved Function (MFPF) at 12 Months
Mature Fistula with Preserved Function at 12 Months (MFPF) defined as a fistula that can be cannulated with 2 needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of ≥300 mL/min (unless the prescribed Qb is <300 mL/min) performed during any continuous 30-day period that commences no later than 180 days after randomization (i.e., fistula achieves FM) AND can be used for dialysis using 2-needles for at least 75% of the for the dialysis sessions performed during a 30-day period that commences on day 330 (FSD12).
MFPF will be summarized by plotting the (inverted) Kaplan-Meier (KM) curves for the treatment and control groups. The MFPF proportions (and associated 95% CIs) for MFPF for the two groups will be evaluated on day 360.
Measured: 12 Months
Percentage of Participants With Durable Fistula Maturation (DFM) at 12 Months
Durable Fistula Maturation (DFM) defined as a fistula that can be cannulated with 2 needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of ≥300 mL/min performed during any continuous 30-day period that commences no later than 180 days after randomization (i.e., fistula achieves FM) AND can be used for dialysis using 2-needles with a mean Qb of ≥300 mL/min for the dialysis sessions performed during a 30-day period that commences on day 330.
DFM will be summarized by plotting the (inverted) Kaplan-Meier (KM) curves for the treatment and control groups. The DFM proportions (and associated 95% CIs) for DFM for the two groups will be evaluated on day 360.
Measured: 12 Months
Cumulative Fistula Use (CFU)
Cumulative Fistula Use (CFU) defined as the number of dialysis sessions performed using the study fistula with 2 needles and a mean Qb of ≥300 mL/min. CFU is calculated from the time of fistula creation to the end of study period or upon reaching an intercurrent event (Fistula abandonment, Death, Transfer to PD or transplant) or is lost to follow up.
CFU was calculated for each participant and then averaged together.
Measured: 12 Months
Cumulative Catheter Exposure (CCE)
Cumulative Catheter Exposure (CCE) is defined as the number of days a hemodialysis central venous catheter (CVC) is in situ and the duration of CVC exposure is calculated from the day of fistula creation (i.e., day of randomization) to the end of study period or upon reaching an intercurrent event.
CFU was calculated for each participant and then averaged together.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start26 Aug 2022
- Primary completion18 Mar 2025
- Study completion29 Aug 2025
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 Complication of Renal DialysisStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vascular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sriram Iyer, MD, Study director, Vascular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05425056
- Sponsor's protocol ID
- VT-305
- Acronym
- ACCESS2
- Status last verified
- Aug 2024
- First submitted
- 10 Jun 2022
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) collected in this study will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Prospective, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus Eluting Collagen Implant (The ACCESS 2 Trial)
- ClinicalTrials.gov ID
- NCT05425056
- Acronym / sponsor ID
- ACCESS2 / VT-305
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD, Chronic Kidney Failure, Complication of Hemodialysis
- Keywords
- Arteriovenous Fistula, Hemodialysis vascular access, Dialysis fistula, Dialysis access
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Vascular Therapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 18 Mar 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 6 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an arteriovenous fistula for hemodialysis vascular access.
Detailed description
This is a Phase 3, multicenter, randomized, single-blind, controlled, study designed to evaluate the efficacy and safety of the use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects who are on hemodialysis and are undergoing surgical creation of an AV fistula in comparison to subjects who do not receive the implant.
Subjects of either gender, who are at least 65 years of age, undergoing hemodialysis, and require a new single stage radiocephalic end to side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation will be eligible for enrollment. The study plans to enroll approximately 120 subjects, randomized in a 1:1 ratio. Enrolled subjects will be followed for a period of one year from the time of their index surgical procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: SirolimusSubjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI). |
| Control Arm | No intervention | –Subjects randomized to the control arm will undergo AV fistula surgery alone and will not receive an implant. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age 65 years or older
- Currently on hemodialysis for ≤12 months
- Successful creation of a single stage radiocephalic end to side fistula
Key exclusion criteria (5 listed)
- Prior AV access created on the limb where the fistula surgery is planned
- Planned start of peritoneal dialysis within 6 months of randomization
- Known hypersensitivity to the following: sirolimus, beef or bovine collagen
- Known to be HIV positive
- Prisoner, mentally incompetent, and/or current alcohol or drug abuser
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 |
|---|---|---|
| SirolimusAlso: Sirolimus-eluting Collagen Implant, SeCI, SirogenSeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery. | Drug | Treatment Arm |
Primary outcome
Percentage of Participants With Clinical Fistula Maturation (FM)
Time frame: 6 Months
Clinical Fistula Maturation (FM) is defined as a fistula that can be cannulated with 2-needles for at least 75% of the dialysis sessions, including 3 consecutive sessions with a mean Qb of 300 mL/min (unless the prescribed Qb is <300 mL/min) performed during any continuous 30 day period that commences no later than 180 days after randomization. FM will be summarized by plotting the (inverted) Kaplan-Meier (KM) curves for the treatment and control groups. The KM proportions (and associated 95% CIs) for FM for the two groups will be evaluated on day 210.
7 secondary outcomes
Fistula Suitability for Dialysis at 12 Months (FSD12)
Time frame: 1 year
Percentage of Participants With Secondary Patency at 12 Months
Time frame: 12 Months
Percentage of Participants With First Dialysis (TTFD) at 12 Months
Time frame: 12 Months
Percentage of Participants With Mature Fistula With Preserved Function (MFPF) at 12 Months
Time frame: 12 Months
Percentage of Participants With Durable Fistula Maturation (DFM) at 12 Months
Time frame: 12 Months
Cumulative Fistula Use (CFU)
Time frame: 12 Months
Cumulative Catheter Exposure (CCE)
Time frame: 12 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data (IPD) collected in this study will not be shared.
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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.
Sriram Iyer, MD study director
Vascular Therapies, Inc.
22 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sirolimus in people with Complication of Renal Dialysis and End Stage Renal Disease, run by Vascular Therapies, Inc. at 22 sites in 2 countries.
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 5 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2026). 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?
Percentage of Participants With Clinical Fistula Maturation (FM) (time frame: 6 Months). 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 6 Oct 2026.