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

ID#: NCT05425056

Age: 65 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: August 26, 2022

End Date: September 01, 2024

Contact Information:
Rakesh Raghubanshi
201-266-8310
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:

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
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