Summary

Eligibility
for people ages 65 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Phase 3, Prospective, Randomized, Multicenter, Single-blind, Controlled Study Evaluating Arteriovenous Fistula Outcomes With and Without a Perivascular Sirolimus Eluting Collagen Implant (The ACCESS 2 Trial)

Details

This is a Phase 3, multicenter, randomized, single-blind, controlled, study designed to evaluate the efficacy and safety of the use of the Sirolimus-eluting Collagen Implant (SeCI) in subjects who are on hemodialysis and are undergoing surgical creation of an AV fistula in comparison to subjects who do not receive the implant. Subjects of either gender, who are at least 65 years of age, undergoing hemodialysis, and require a new single stage radiocephalic end to side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation will be eligible for enrollment. The study plans to enroll approximately 120 subjects, randomized in a 1:1 ratio. Enrolled subjects will be followed for a period of one year from the time of their index surgical procedure.

Keywords

Complication of Renal Dialysis End Stage Renal Disease End Stage Kidney Disease ESRD Chronic Kidney Failure Complication of Hemodialysis Vascular Access Complication Arteriovenous Fistula Hemodialysis vascular access Dialysis fistula Dialysis access Kidney Diseases Kidney Failure, Chronic Renal Insufficiency Fistula Sirolimus

Eligibility

You can join if…

Open to people ages 65 years and up

  • Age 65 years or older
  • Currently on hemodialysis for ≤12 months
  • Successful creation of a single stage radiocephalic end to side fistula

You CAN'T join 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

Locations

  • University of California San Francisco not yet accepting patients
    San Francisco California 94143 United States
  • Lundquist Institute for Biomedical Innovation accepting new patients
    Torrance California 90502 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Vascular Therapies, Inc.
ID
NCT05425056
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated