Sirogen for Arteriovenous Fistula Outcomes
(ACCESS2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
Is sirolimus generally safe for humans?
Sirolimus, also known as Rapamune, is generally considered safe for humans and has been used since 1999 to prevent organ rejection in kidney transplants. It has a lower risk of kidney, nerve, and certain blood-related complications compared to other similar drugs, but it can increase lipid levels (fats in the blood) in some patients.12345
What data supports the effectiveness of the drug Sirolimus (Rapamune) for improving arteriovenous fistula outcomes?
Who Is on the Research Team?
Sriram Iyer, MD
Principal Investigator
Vascular Therapies, Inc.
Are You a Good Fit for This Trial?
This trial is for people aged 65 or older who have been on hemodialysis for less than a year and are getting a new arteriovenous fistula. It's not for those with previous AV access in the same limb, planned peritoneal dialysis soon, sirolimus or bovine collagen allergies, HIV positive individuals, prisoners, or substance abusers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo AV fistula surgery, with the treatment arm receiving the Sirolimus eluting Collagen Implant (SeCI)
Follow-up
Participants are monitored for fistula maturation and safety for one year after surgery
What Are the Treatments Tested in This Trial?
Interventions
- Sirolimus
Sirolimus is already approved in United States, European Union, Canada, Japan for the following indications:
- Prevention of organ rejection in kidney transplant patients
- Treatment of lymphangioleiomyomatosis (LAM)
- Prevention of organ rejection in kidney transplant patients
- Treatment of lymphangioleiomyomatosis (LAM)
- Prevention of organ rejection in kidney transplant patients
- Treatment of lymphangioleiomyomatosis (LAM)
- Prevention of organ rejection in kidney transplant patients
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vascular Therapies, Inc.
Lead Sponsor