CompletedPhase 3

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

United States136 participantsStarted 2022-08-26

Plain-language 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.

Who can participate

Age range65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Clinical Fistula Maturation (FM)

Timeframe: 6 Months

Trial details

NCT IDNCT05425056

SponsorVascular Therapies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-03-18

View on ClinicalTrials.gov More Complication of Renal Dialysis trials