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

NCT05425056 | Completed Phase 3 FDA Drug

• 1 other identifier: VT-305
• Study Type: interventional
• Target: 136
• Locations: 2 countries
• Sites: 22

Brief 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.

Conditions

Complication of Renal Dialysis; End Stage Renal Disease; End Stage Kidney Disease; ESRD; Chronic Kidney Failure; Complication of Hemodialysis; Vascular Access Complication; Arteriovenous Fistula

Keywords

Arteriovenous Fistula; Hemodialysis vascular access; Dialysis fistula; Dialysis access

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Fistula Suitability for Dialysis at 12 months (FSD12)

  1 year

• Secondary Patency (SP)

  1 year

• Time To First Dialysis (TTFD)

  1 year

• Mature Fistula with Preserved Function at 12 Months (MFPF)

  1 year

• Durable Fistula Maturation (DFM)

  1 year

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Subjects randomized to the treatment arm will undergo AV fistula surgery and will receive the Sirolimus eluting Collagen Implant (SeCI).

Drug: Sirolimus

Control Arm

NO INTERVENTION

Subjects randomized to the control arm will undergo AV fistula surgery alone and will not receive an implant.

Interventions

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.

Also known as: Sirolimus-eluting Collagen Implant, SeCI, Sirogen

Treatment Arm

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vascular Therapies, Inc.: lead

Study Sites (22)

Veterans Affairs San Diego Health Center

San Diego, California, 92161, United States

Location

Lundquist Institute for Biomedical Innovation

Torrance, California, 90502, United States

Location

MedStar Cardiovascular Research Network at MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

American Access Care of Miami

Miami, Florida, 33156, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

The Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Atrium Health

Charlotte, North Carolina, 28204, United States

Location

Surgical Specialists of Charlotte

Charlotte, North Carolina, 28207, United States

Location

The Regional Medical Center/Dialysis Access Institute

Orangeburg, South Carolina, 29118, United States

Location

James Eric Gardner, MD PC

Memphis, Tennessee, 38115, United States

Location

Arteries & Veins

El Paso, Texas, 79912, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Houston Methodist

Sugar Land, Texas, 77479, United States

Location

Sentara Norfolk General Hospital/Sentara Health Research Center

Norfolk, Virginia, 23507, United States

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

St Helier Hospital

Carshalton, SM5 1AA, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

Barts Health NHS Trust of Royal London Hospital

London, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Arteriovenous Fistula

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Sriram Iyer, MD

  Vascular Therapies, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 21, 2022
• Study Start: August 26, 2022
• Primary Completion: March 18, 2025
• Study Completion: August 29, 2025
• Last Updated: September 24, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (17); GB (5)