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

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

Sex: All

Ages: 65 Years – N/A

Healthy volunteers: No

Phase: PHASE3

Enrollment: 136

Sponsor: Vascular Therapies, Inc.

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05425056). StuddyBuddy aggregates publicly available trial information.