Skip to main content
OpenTrials
Completed

NCT Number: NCT05425056

A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complication of Renal Dialysis Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Chronic Kidney Failure Complication of Hemodialysis Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes ESRD End Stage Kidney Disease End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Access Complication Vascular Diseases Vascular Fistula Vascular Malformations

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 65 years or older
  • Currently on hemodialysis for ≤12 months
  • Successful creation of a single stage radiocephalic end to side fistula

Exclusion criteria

  • 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

Treatment and study plan

sirolimus

Drug

SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.

Other names: Sirolimus-eluting Collagen Implant, SeCI, Sirogen

Primary outcomes

  1. 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.

    The primary endpoint will be summarized as a time-to-event endpoint for the SeCI (Sirogen) and control groups by reporting the cumulative proportion of AVF that achieve FM over time [defined as the interval from access placement to the first session that the fistula can be cannulated with 2 needles (contributing to the FM definition)].

Secondary outcomes

  1. Fistula Suitability for Dialysis at 12 months (FSD12)

    Time frame: 1 year

    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.

  2. Secondary Patency (SP)

    Time frame: 1 year

    Secondary Patency (SP) defined as the interval from the time of randomization until access abandonment.

  3. Time To First Dialysis (TTFD)

    Time frame: 1 year

    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).

  4. Mature Fistula with Preserved Function at 12 Months (MFPF)

    Time frame: 1 year

    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).

  5. Durable Fistula Maturation (DFM)

    Time frame: 1 year

    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.

  6. Cumulative Fistula Use (CFU)

    Time frame: 1 year

    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.

  7. Cumulative Catheter Exposure (CCE)

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Vascular Therapies, Inc.

Industry

Registry information

Official study 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)

Acronym: ACCESS2

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.