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

• Status: Not yet recruiting
• Trial end date: 2024-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vascular Therapies, Inc.
• Treatments: Sirolimus

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