A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
Completed · Phase 3
Conditions studied: Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD, Chronic Kidney Failure, Complication of Hemodialysis, Vascular Access Complication, Arteriovenous Fistula
In brief
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.
Key facts
- Study ID
- NCT05425056
- Run by
- Vascular Therapies, Inc.
- People needed
- 136
- Starts
- 2022-08-26
- Expected to finish
- 2025-08-29
- Last updated by the study team
- 2025-09-24
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Veterans Affairs San Diego Health Center — San Diego, California, United States
- Lundquist Institute for Biomedical Innovation — Torrance, California, United States
- MedStar Cardiovascular Research Network at MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- American Access Care of Miami — Miami, Florida, United States
- Emory University Hospital Midtown — Atlanta, Georgia, United States
- Augusta University — Augusta, Georgia, United States
- University of Louisville — Louisville, Kentucky, United States
- The Brigham and Women's Hospital — Boston, Massachusetts, United States
- Mount Sinai Hospital — New York, New York, United States
- Atrium Health — Charlotte, North Carolina, United States
- Surgical Specialists of Charlotte — Charlotte, North Carolina, United States
- The Regional Medical Center/Dialysis Access Institute — Orangeburg, South Carolina, United States
- James Eric Gardner, MD PC — Memphis, Tennessee, United States
- Arteries & Veins — El Paso, Texas, United States
- Houston Methodist — Houston, Texas, United States
- Houston Methodist — Sugar Land, Texas, United States
- Sentara Norfolk General Hospital/Sentara Health Research Center — Norfolk, Virginia, United States
- University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom
- St Helier Hospital — Carshalton, United Kingdom
- NHS Greater Glasgow and Clyde — Glasgow, United Kingdom
- Barts Health NHS Trust of Royal London Hospital — London, United Kingdom
- St George's University Hospitals NHS Foundation Trust — London, United Kingdom
Full record on ClinicalTrials.gov
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