A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery (ACCESS2)

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease; ESRD; End Stage Kidney Disease; Arteriovenous Fistula; Vascular Access Complication; Chronic Kidney Failure; Complication of Hemodialysis; Complication of Renal Dialysis
• Intervention / Treatment: Drug: Sirolimus

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 Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Contacts and Locations

Study Locations

• United Kingdom
  • Birmingham, United Kingdom
    • University Hospitals Birmingham NHS Foundation Trust
  • Carshalton, United Kingdom, SM5 1AA
    • St Helier Hospital
  • Glasgow, United Kingdom
    • NHS Greater Glasgow and Clyde
  • London, United Kingdom
    • St George's University Hospitals NHS Foundation Trust
  • London, United Kingdom
    • Barts Health NHS Trust of Royal London Hospital
• United States
  • California
    • San Diego, California, United States, 92161
      • Veterans Affairs San Diego Health Center
    • Torrance, California, United States, 90502
      • Lundquist Institute for Biomedical Innovation
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Cardiovascular Research Network at MedStar Washington Hospital Center
  • Florida
    • Miami, Florida, United States, 33156
      • American Access Care of Miami
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital Midtown
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • The Brigham and Women's Hospital
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Surgical Specialists of Charlotte
    • Charlotte, North Carolina, United States, 28204
      • Atrium Health
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • The Regional Medical Center/Dialysis Access Institute
  • Tennessee
    • Memphis, Tennessee, United States, 38115
      • James Eric Gardner, MD PC
  • Texas
    • El Paso, Texas, United States, 79912
      • Arteries & Veins
    • Houston, Texas, United States, 77030
      • Houston Methodist
    • Sugar Land, Texas, United States, 77479
      • Houston Methodist
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital/Sentara Health Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm; Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI).	Drug: Sirolimus; 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
No Intervention: Control Arm; Subjects randomized to the control arm will undergo AV fistula surgery alone and will not receive an implant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. 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)].	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
Secondary Patency (SP)	Secondary Patency (SP) defined as the interval from the time of randomization until access abandonment.	1 year
Time To First Dialysis (TTFD)	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).	1 year
Mature Fistula with Preserved Function at 12 Months (MFPF)	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).	1 year
Durable Fistula Maturation (DFM)	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.	1 year
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.	1 year
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.	1 year

Collaborators and Investigators

• Sponsor: Vascular Therapies, Inc.
• Investigators: Study Director: Sriram Iyer, MD, Vascular Therapies, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2022
• Primary Completion (Actual): March 18, 2025
• Study Completion (Actual): August 29, 2025

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 18, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Arteriovenous Fistula; Hemodialysis vascular access; Dialysis fistula; Dialysis access
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Congenital Abnormalities; Cardiovascular Abnormalities; Renal Insufficiency, Chronic; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Arteriovenous Fistula; Organic Chemicals; Macrolides; Lactones; Sirolimus
• Other Study ID Numbers: VT-305

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) collected in this study will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No